LAPORAN RESMI PRAKTIKUM

TEKNOLOGI FORMULASI SEDIAAN STERIL

PERCOBAAN I
PENCUCIAN DAN STERILISASI PENGEMAS

Disusun oleh :
Nama : Ni Putu Desy Anggraeni
NIM : 17/411941/FA/11370
Kelas/Golongan : C/II A
Hari/Jam Praktikum : Kamis/11.00-15.00
Tanggal Praktikum : 5 Maret 2020
Dosen Pembimbing : Dr. Eng. Khadijah, M.Si., Apt.

LABORATORIUM TEKNOLOGI FARMASI

DEPARTEMEN FARMASETIKA
FAKULTAS FARMASI
UNIVERSITAS GADJAH MADA
YOGYAKARTA
2020
 Alcohol A

1 Nonproprietary Names In the USP 32, the term ‘dehydrated alcohol’ refers to ethanol
BP: Ethanol (96%) 599.5% v/v. The term ‘alcohol’ without other qualification refers
to ethanol 94.9–96.0% v/v.
JP: Ethanol In the JP XV, ethanol (alcohol) contains 95.1–96.9% v/v (by
PhEur: Ethanol (96 per cent) specific gravity) of C2H6O at 158C.
USP: Alcohol In the Handbook of Pharmaceutical Excipients, the term
‘alcohol’ is used for either ethanol 95% v/v or ethanol 96% v/v.
2 Synonyms Alcohol is a clear, colorless, mobile, and volatile liquid with a
slight, characteristic odor and burning taste.
Ethanolum (96 per centum); ethyl alcohol; ethyl hydroxide; grain
See also Section 17.
alcohol; methyl carbinol.
9 Pharmacopeial Specifications
3 Chemical Name and CAS Registry Number
See Table II. See also Sections 17 and 18.
Ethanol [64-17-5]
Table II: Pharmacopeial specifications for alcohol.
4 Empirical Formula and Molecular Weight
C2H6O 46.07 Test JP XV PhEur 6.0 USP 32
Identification þ þ þ
5 Structural Formula Characters — þ —
Specific gravity 0.809–0.816 0.805–0.812 0.812–0.816
Acidity or alkalinity þ þ þ
Clarity and color of þ þ þ
solution
Nonvolatile residue 42.5 mg 425 ppm 42.5 mg
Volatile impurities þ þ þ
6 Functional Category Absorbance þ þ þ
Antimicrobial preservative; disinfectant; skin penetrant; solvent. at 240 nm 40.40 40.40 40.40
at 250–260 nm 40.30 40.30 40.30
at 270–340 nm 40.10 40.10 40.10
7 Applications in Pharmaceutical Formulation or Assay 95.1–96.9% 95.1–96.9% 92.3–93.8%
Technology by weight
Ethanol and aqueous ethanol solutions of various concentrations 94.9–96.0%
(see Sections 8 and 17) are widely used in pharmaceutical by volume
formulations and cosmetics; see Table I. Although ethanol is
primarily used as a solvent, it is also employed as a disinfectant, and
in solutions as an antimicrobial preservative.(1,2) Topical ethanol 10 Typical Properties
solutions are used in the development of transdermal drug delivery
systems as penetration enhancers.(3–10) Ethanol has also been used Antimicrobial activity Ethanol is bactericidal in aqueous mix-
in the development of transdermal preparations as a co-surfac- tures at concentrations between 60% and 95% v/v; the optimum
tant.(11–13) concentration is generally considered to be 70% v/v. Antimicro-
bial activity is enhanced in the presence of edetic acid or edetate
salts.(1) Ethanol is inactivated in the presence of nonionic
Table I: Uses of alcohol.
surfactants and is ineffective against bacterial spores.
Use Concentration (% v/v) Boiling point 78.158C
Flammability Readily flammable, burning with a blue, smokeless
Antimicrobial preservative 510 flame.
Disinfectant 60–90
Extracting solvent in galenical manufacture Up to 85
Flash point 148C (closed cup)
Solvent in film coating Variable NIR spectra see Figures 1 and 2.
Solvent in injectable solutions Variable Solubility Miscible with chloroform, ether, glycerin, and water
Solvent in oral liquids Variable (with rise of temperature and contraction of volume).
Solvent in topical products 60–90 Specific gravity 0.8119–0.8139 at 208C
Note The above typical properties are for alcohol (ethanol 95% or
96% v/v). See Section 17 for typical properties of dehydrated
alcohol.
8 Description
In the BP 2009, the term ‘ethanol’ used without other qualification 11 Stability and Storage Conditions
refers to ethanol containing 599.5% v/v of C2H6O. The term
Aqueous ethanol solutions may be sterilized by autoclaving or by
‘alcohol’, without other qualification, refers to ethanol 95.1–96.9%
filtration and should be stored in airtight containers, in a cool place.
v/v. Where other strengths are intended, the term ‘alcohol’ or
‘ethanol’ is used, followed by the statement of the strength.
In the PhEur 6.0, anhydrous ethanol contains not less than 12 Incompatibilities
99.5% v/v of C2H6O at 208C. The term ethanol (96%) is used to In acidic conditions, ethanol solutions may react vigorously with
describe the material containing water and 95.1–96.9% v/v of oxidizing materials. Mixtures with alkali may darken in color
C2H6O at 208C. owing to a reaction with residual amounts of aldehyde. Organic

17
 18 Alcohol
2.0
A
6.0 2292 Although symptoms of ethanol intoxication are usually encoun-
1000 × [2nd deriv. log(1/R)] 2252
2338
tered following deliberate consumption of ethanol-containing
2369 beverages, many pharmaceutical products contain ethanol as a
1671 solvent, which, if ingested in sufficiently large quantities, may cause
adverse symptoms of intoxication. In the USA, the maximum

1og(1/R)
0.0 quantity of alcohol included in OTC medicines is 10% v/v for
1185
1938
2076 products labeled for use by people of 12 years of age and older, 5%
1692 1734 v/v for products intended for use by children aged 6–12 years of age,
2463
and 0.5% v/v for products for use by children under 6 years of
age.(14)
Parenteral products containing up to 50% of alcohol (ethanol 95
2354 or 96% v/v) have been formulated. However, such concentrations
2270 2309 can produce pain on intramuscular injection and lower concentra-
−9.0 0.0 tions such as 5–10% v/v are preferred. Subcutaneous injection of
1100 1300 1500 1700 1900 2100 2300 2500
alcohol (ethanol 95% v/v) similarly causes considerable pain
Wavelength/nm followed by anesthesia. If injections are made close to nerves,
neuritis and nerve degeneration may occur. This effect is used
Figure 1: Near-infrared spectrum of alcohol (96%) measured by therapeutically to cause anesthesia in cases of severe pain, although
transflectance (1 mm path-length). the practice of using alcohol in nerve blocks is controversial. Doses
6.0 2.0 of 1 mL of absolute alcohol have been used for this purpose.(15)
1000 × [2nd deriv. log(1/R)]

2292 2339
2252
Preparations containing more than 50% v/v alcohol may cause
2369 skin irritation when applied topically.
1671
LD50 (mouse, IP): 0.93 g/kg(16)
LD50 (mouse, IV): 1.97 g/kg
1og(1/R)
0.0
1185 2078
LD50 (mouse, oral): 3.45 g/kg
1692 1734 LD50 (mouse, SC): 8.29 g/kg
LD50 (rat, IP): 3.75 g/kg
2462
LD50 (rat, IV): 1.44 g/kg
LD50 (rat, oral): 7.06 g/kg
2355
2270 2309
−9.0 0.0 15 Handling Precautions
1100 1300 1500 1700 1900 2100 2300 2500
Observe normal precautions appropriate to the circumstances and
Wavelength/nm quantity of material handled. Ethanol and aqueous ethanol
solutions should be handled in a well-ventilated environment. In
Figure 2: Near-infrared spectrum of alcohol (absolute) measured by the UK, the long-term 8-hour TWA workplace exposure limit for
transflectance (1 mm path-length). ethanol is 1920 mg/m3 (1000 ppm).(17) Ethanol may be irritant to
the eyes and mucous membranes, and eye protection and gloves are
recommended. Ethanol is flammable and should be heated with
salts or acacia may be precipitated from aqueous solutions or care. Fixed storage tanks should be electrically grounded to avoid
dispersions. Ethanol solutions are also incompatible with aluminum ignition from electrostatic discharges when ethanol is transferred.
containers and may interact with some drugs.
16 Regulatory Status
13 Method of Manufacture
Included in the FDA Inactive Ingredients Database (dental
Ethanol is manufactured by the controlled enzymatic fermentation preparations; inhalations; IM, IV, and SC injections; nasal and
of starch, sugar, or other carbohydrates. A fermented liquid is ophthalmic preparations; oral capsules, solutions, suspensions,
produced containing about 15% ethanol; ethanol 95% v/v is then syrups, and tablets; rectal, topical, and transdermal preparations).
obtained by fractional distillation. Ethanol may also be prepared by Included in the Canadian List of Acceptable Non-medicinal
a number of synthetic methods. Ingredients. Included in nonparenteral and parenteral medicines
licensed in the UK.
14 Safety
Ethanol and aqueous ethanol solutions are widely used in a variety 17 Related Substances
of pharmaceutical formulations and cosmetics. It is also consumed Dehydrated alcohol; denatured alcohol; dilute alcohol; isopropyl
in alcoholic beverages. alcohol.
Ethanol is rapidly absorbed from the gastrointestinal tract and Dehydrated alcohol
the vapor may be absorbed through the lungs; it is metabolized, Synonyms Absolute alcohol; anhydrous ethanol; ethanol.
mainly in the liver, to acetaldehyde, which is further oxidized to Autoignition temperature 3658C
acetate. Boiling point 78.58C
Ethanol is a central nervous system depressant and ingestion of Explosive limits 3.5–19.0% v/v in air
low to moderate quantities can lead to symptoms of intoxication Flash point 128C (closed cup)
including muscle incoordination, visual impairment, slurred speech, Melting point 1128C
etc. Ingestion of higher concentrations may cause depression of Moisture content Absorbs water rapidly from the air.
medullary action, lethargy, amnesia, hypothermia, hypoglycemia, Refractive index n 20D = 1.361
stupor, coma, respiratory depression, and cardiovascular collapse. Specific gravity 0.7904–0.7935 at 208C
The lethal human blood-alcohol concentration is generally esti- Surface tension 22.75 mN/m at 208C (ethanol/vapor)
mated to be 400–500 mg/100 mL. Vapor density (relative) 1.59 (air = 1)

Vapor pressure 5.8 Pa at 208C
Viscosity (dynamic) 1.22 mPa s (1.22 cP) at 208C
Comments Dehydrated alcohol is ethanol 599.5% v/v. See
Section 8. Dehydrated alcohol is one of the materials that have
been selected for harmonization by the Pharmacopeial Discus-
sion Group. For further information see the General Information
Chapter <1196> in the USP32–NF27, the General Chapter 5.8
in PhEur 6.0, along with the ‘State of Work’ document on the
PhEur EDQM website, and also the General Information
Chapter 8 in the JP XV.
Denatured alcohol
Synonyms Industrial methylated spirit; surgical spirit.
Comments Denatured alcohol is alcohol intended for external use
only. It has been rendered unfit for human consumption by the
addition of a denaturing agent such as methanol or methyl
isobutyl ketone.
Dilute alcohol
Synonyms Dilute ethanol.
Specific gravity see Table III.
Table III: Specific gravity of alcohol.
Strength of alcohol (% v/v) Specific gravity at 208C
90 0.8289–0.8319
80 0.8599–0.8621
70 0.8860–0.8883
60 0.9103–0.9114
50 0.9314–0.9326
45 0.9407–0.9417
25 0.9694–0.9703
20 0.9748–0.9759
Comments The term ‘dilute alcohol’ refers to a mixture of ethanol
and water of stated concentration. The USP32–NF27 lists
diluted alcohol. The BP 2009 lists eight strengths of dilute
alcohol ( dilute ethanol) containing 90%, 80%, 70%, 60%,
50%, 45%, 25%, and 20% v/v respectively of ethanol.
18 Comments
Alcohol is one of the materials that have been selected for
harmonization by the Pharmacopeial Discussion Group. For further
information see the General Information Chapter <1196> in the
USP32–NF27, the General Chapter 5.8 in PhEur 6.0, along with the
‘State of Work’ document on the PhEur EDQM website, and also
the General Information Chapter 8 in the JP XV.
Possession and use of nondenatured alcohols are usually subject
to close control by excise authorities.
A specification for alcohol is contained in the Food Chemicals
Codex (FCC).(18)
The EINECS number for alcohol is 200-578-6. The PubChem
Compound ID (CID) for alcohol is 702.
19 Specific References
1 Chiori CO, Ghobashy AA. A potentiating effect of EDTA on the
bactericidal activity of lower concentrations of ethanol. Int J Pharm
1983; 17: 121–128.
Alcohol 19
A
2 Karabit MS et al. Studies on the evaluation of preservative efficacy. IV.
The determination of antimicrobial characteristics of some pharma-
ceutical compounds in aqueous solutions. Int J Pharm 1989; 54: 51–56.
3 Liu P et al. Quantitative evaluation of ethanol effects on diffusion and
metabolism of b-estradiol in hairless mouse skin. Pharm Res 1991; 8(7):
865–872.
4 Verma DD, Fahr A. Synergistic penetration enhancement of ethanol and
phospholipids on the topical delivery of cyclosporin A. J Control
Release 2004; 97(1): 55–66.
5 Gwak SS et al. Transdermal delivery of ondansetron hydrochloride:
effects of vehicles and penetration enhancers. Drug Dev Ind Pharm
2004; 30(2): 187–194.
6 Williams AC, Barry BW. Penetration enhancers. Adv Drug Delivery Rev
2004; 56(5): 603–618.
7 Heard CA et al. Skin penetration enhancement of mefenamic acid by
ethanol and 1,8-cineole can be explained by the ‘pull’ effect. Int J Pharm
2006; 321: 167–170.
8 Rhee YS et al. Effects of vehicles and enhancers on transdermal delivery
of clebopride. Arch Pharm Res 2007; 30: 1155–1161.
9 Fang C et al. Synergistically enhanced transdermal permeation and
topical analgesia of tetracaine gel containing menthol and ethanol in
experimental and clinical studies. Eur J Pharm Biopharm 2008; 68:
735–740.
10 Krishnaiah YS et al. Penetration-enhancing effect of ethanolic solution
of menthol on transdermal permeation of ondansetron hydrochloride
across rat epidermis. Drug Deliv 2008; 15: 227–234.
11 Kweon JH et al. Transdermal delivery of diclofenac using microemul-
sions. Arch Pharmacol Res 2004; 27(3): 351–356.
12 Huang YB et al. Transdermal delivery of capsaicin derivative-sodium
nonivamide acetate using microemulsions as vehicles. Int J Pharm
2008; 349: 206–211.
13 El Maghraby GM. Transdermal delivery of hydrocortisone from
eucalyptus oil microemulsion: effects of cosurfactants. Int J Pharm
2008; 355: 285–292.
14 Jass HE. Regulatory review. Cosmet Toilet 1995; 110(5): 21–22.
15 Lloyd JW. Use of anaesthesia: the anaesthetist and the pain clinic. Br
Med J 1980; 281: 432–434.
16 Lewis RJ, ed. Sax’s Dangerous Properties of Industrial Materials, 11th
edn. New York: Wiley, 2004; 1627–1628.
17 Health and Safety Executive. EH40/2005: Workplace Exposure Limits.
Sudbury: HSE Books, 2005 (updated 2007). http://www.hse.gov.uk/
coshh/table1.pdf (accessed 5 February 2009).
18 Food Chemicals Codex, 6th edn. Bethesda, MD: United States
Pharmacopeia, 2008; 303.
20 General References
European Directorate for the Quality of Medicines and Healthcare
(EDQM). European Pharmacopoeia – State Of Work Of International
Harmonisation. Pharmeuropa 2009; 21(1): 142–143. http://www.edq-
m.eu/site/-614.html (accessed 3 February 2009).
Lund W, ed. The Pharmaceutical Codex: Principles and Practice of
Pharmaceutics, 12th edn. London: Pharmaceutical Press, 1994; 694–
695.
Spiegel AJ, Noseworthy MN. Use of nonaqueous solvents in parenteral
products. J Pharm Sci 1963; 52: 917–927.
Wade A, ed. Pharmaceutical Handbook, 19th edn. London: Pharmaceutical
Press, 1980; 227–230.
21 Author
ME Quinn.
22 Date of Revision
5 February 2009.
 Hydrochloric Acid

1 Nonproprietary Names Table I: Pharmacopeial specifications for hydrochloric acid.

BP: Hydrochloric Acid
Test JP XV PhEur 6.0 USP32–NF27
JP: Hydrochloric Acid
PhEur: Hydrochloric Acid, Concentrated Identification þ þ þ
Characters þ þ —
USP-NF: Hydrochloric Acid Appearance of solution — þ —
Residue on ignition 41.0 mg — 40.008%
Residue on evaporation — 40.01% —
Bromide or iodide þ — þ
2 Synonyms Free bromine þ — þ
Free chlorine þ 1 ppm (max.) þ
Acidum hydrochloridum concentratum; chlorohydric acid; concen- Sulfate þ 5 ppm (max.) þ
trated hydrochloric acid; E507. Sulfite þ — þ
Arsenic 41 ppm — —
H Heavy metals
Mercury
45 ppm
40.04 ppm
42 ppm
—
45 ppm
—
Assay (of HCl) 35.0–38.0% 35.0–39.0% 36.5–38.0%
3 Chemical Name and CAS Registry Number
Hydrochloric acid [7647-01-0]
10 Typical Properties
Acidity/alkalinity pH = 0.1 (10% v/v aqueous solution)
4 Empirical Formula and Molecular Weight Boiling point 1108C (constant boiling mixture of 20.24% w/w
HCl 36.46 HCl)
Density 1.18 g/cm3 at 208C
Freezing point 248C
Refractive index n 20
D = 1.342 (10% v/v aqueous solution)

5 Structural Formula Solubility Miscible with water; soluble in diethyl ether, ethanol
(95%), and methanol.
See Section 4.
11 Stability and Storage Conditions
Hydrochloric acid should be stored in a well-closed, glass or other
6 Functional Category inert container at a temperature below 308C. Storage in close
proximity to concentrated alkalis, metals, and cyanides should be
Acidifying agent.
avoided.

7 Applications in Pharmaceutical Formulation or
Technology
Hydrochloric acid is widely used as an acidifying agent, in a variety
of pharmaceutical and food preparations (see Section 16). It may
also be used to prepare dilute hydrochloric acid, which in addition
to its use as an excipient has some therapeutic use, intravenously in
the management of metabolic alkalosis, and orally for the treatment
of achlorhydria. See Section 17.
12 Incompatibilities
Hydrochloric acid reacts violently with alkalis, with the evolution of
a large amount of heat. Hydrochloric acid also reacts with many
metals, liberating hydrogen.
13 Method of Manufacture
Hydrochloric acid is an aqueous solution of hydrogen chloride gas
produced by a number of methods including: the reaction of sodium
chloride and sulfuric acid; the constituent elements; as a by-product
from the electrolysis of sodium hydroxide; and as a by-product
during the chlorination of hydrocarbons.

8 Description
Hydrochloric acid occurs as a clear, colorless, fuming aqueous
solution of hydrogen chloride, with a pungent odor.
The JP XV specifies that hydrochloric acid contains 35.0–38.0%
w/w of HCl; the PhEur 6.0 specifies that hydrochloric acid contains
35.0–39.0% w/w of HCl; and the USP32–NF27 specifies that
hydrochloric acid contains 36.5–38.0% w/w of HCl. See also
Section 9.
14 Safety
When used diluted, at low concentration, hydrochloric acid is not
usually associated with any adverse effects. However, the concen-
trated solution is corrosive and can cause severe damage on contact
with the eyes and skin, or if ingested.
LD50 (mouse, IP): 1.4 g/kg(1)
LD50 (rabbit, oral): 0.9 g/kg

15 Handling Precautions
Caution should be exercised when handling hydrochloric acid, and
9 Pharmacopeial Specifications suitable protection against inhalation and spillage should be taken.
See Table I. Eye protection, gloves, face mask, apron, and respirator are

3 08

recommended, depending on the circumstances and quantity of
hydrochloric acid handled. Spillages should be diluted with copious
amounts of water and run to waste. Splashes on the skin and eyes
should be treated by immediate and prolonged washing with large
amounts of water and medical attention should be sought. Fumes
can cause irritation to the eyes, nose, and respiratory system;
prolonged exposure to fumes may damage the lungs. In the UK, the
recommended short-term workplace exposure limit for hydrogen
chloride gas and aerosol mists is 8 mg/m3 (5 ppm). The long-term
exposure limit (8-hour TWA) is 2 mg/m3 (1 ppm).(2)
16 Regulatory Status
GRAS listed. Accepted for use as a food additive in Europe.
Included in the FDA Inactive Ingredients Database (dental
solutions; epidural injections; IM, IV, and SC injections; inhalations;
ophthalmic preparations; oral solutions; nasal, otic, rectal, and
topical preparations). Included in parenteral and nonparenteral
medicines licensed in the UK. Included in the Canadian List of
Acceptable Non-medicinal Ingredients.
17 Related Substances
Dilute hydrochloric acid.
Dilute hydrochloric acid
Synonyms Acidum hydrochloridum dilutum; diluted hydrochlo-
ric acid.
Density 1.05 g/cm3 at 208C
Comments The JP XV and PhEur 6.0 specify that dilute
hydrochloric acid contains 9.5–10.5% w/w of HCl and is
prepared by mixing 274 g of hydrochloric acid with 726 g of
water. The USP32–NF27 specifies 9.5–10.5% w/v of HCl,
prepared by mixing 226 mL of hydrochloric acid with sufficient
water to make 1000 mL.
Hydrophobic Colloidal Silica
1 Nonproprietary Names
BP: Hydrophobic Colloidal Anhydrous Silica
PhEur: Silica, Hydrophobic Colloidal
USP-NF: Hydrophobic Colloidal Silica
2 Synonyms
Aerosil R972; silica dimethyl silylate; silica hydrophobica colloida-
lis; silicic acid, silylated; silicon dioxide, silanated.
3 Chemical Name and CAS Registry Number
Silane, dichloro-dimethyl-, reaction products with silica [68611-
44-9]
4 Empirical Formula and Molecular Weight
SiO2 (partly alkylated for hydrophobation) 60.08
5 Structural Formula
See Section 4.
Hydrophobic Colloidal Silica 30 9
18 Comments
In pharmaceutical formulations, dilute hydrochloric acid is usually
used as an acidifying agent in preference to hydrochloric acid.
Hydrochloric acid is also used therapeutically as an escharotic.(3)
The PhEur 6.0 also contains a specification for hydrochloric acid,
dilute; see Section 17.
A specification for hydrochloric acid is contained in the Food
Chemicals Codex (FCC).(4)
The EINECS number for hydrochloric acid is 231-595-7. The
PubChem Compound ID (CID) for hydrochloric acid is 313.
19 Specific References
1 Lewis RJ, ed. Sax’s Dangerous Properties of Industrial Materials, 11th
edn. New York: Wiley, 2004; 1980.
2 Health and Safety Executive. EH40/2005: Workplace Exposure Limits.
Sudbury: HSE Books, 2005 (updated 2007). http://www.hse.gov.uk/
coshh/table1.pdf (accessed 5 February 2009).
3 Sweetman S, ed. Martindale: The Complete Drug Reference, 36th edn.
H
London: Pharmaceutical Press, 2009; 2322.
4 Food Chemicals Codex, 6th edn. Bethesda, MD: United States
Pharmacopeia, 2008; 458.
20 General References
Japan Pharmaceutical Excipients Council. Japanese Pharmaceutical Exci-
pients Directory 1996. Tokyo: Yakuji Nippo, 1996; 228.
21 Authors
ME Quinn, PJ Sheskey.
22 Date of Revision
5 February 2009.
6 Functional Category
Anticaking agent; emulsion stabilizer; glidant; suspending agent;
thermal stabilizer; viscosity-increasing agent.
7 Applications in Pharmaceutical Formulation or
Technology
Hydrophobic colloidal silica has nano-sized primary particles and a
large specific surface area,(1) which provide desirable flow
characteristics in dry powders used in tableting(2–4) and capsule
filling.(3) The hydrophobic grades absorb less moisture(5) and may
offer an advantage in moisture-sensitive formulations.
Hydrophobic colloidal silica is also used to thixotropically
control viscosity, to thicken and stabilize emulsions, or as a
suspending agent in gels and semisolid preparations. Hydrophobic
colloidal silica has a less pronounced effect on solution viscosity but
can thicken and stabilize the oil phase of a water–oil emulsion.(3,5)
With other ingredients of similar refractive index, transparent gels
may be formed.(5) Generally, the uses and ranges of hydrophobic
colloidal silica are similar to the concentrations used of the standard
hydrophilic colloidal silicon dioxide.
 Sodium Carbonate

1 Nonproprietary Names Table I: Pharmacopeial specifications for sodium carbonate.

BP: Anhydrous Sodium Carbonate
Test JP XV PhEur 6.0 USP32–NF27
JP: Dried Sodium Carbonate
PhEur: Sodium Carbonate, Anhydrous Identification þ þ þ
Characters — þ —
USP-NF: Sodium Carbonate Appearance of solution þ þ —
Alkali hydroxides and — þ —
bicarbonates
2 Synonyms Chlorides 40.071% 4125 ppm —
Bisodium carbonate; calcined soda; carbonic acid disodium salt; Sulfates — 4250 ppm —
Arsenic 43.1 ppm 45 ppm —
cenzias de soda; crystol carbonate; disodium carbonate; E500; Iron — 450 ppm —
natrii carbonas anhydricus; soda ash; soda calcined. Heavy metals 420 ppm 450 ppm 40.001%
Loss on drying 42.0% 41.0% —
Water — — 40.5%
3 Chemical Name and CAS Registry Number Assay (dried basis) >99.0% 99.5–100.5% 99.5–100.5%
Sodium carbonate anhydrous [497-19-8]
Sodium carbonate monohydrate [5968-11-6]
Sodium carbonate decahydrate [6132-02-1]
10 Typical Properties
4 Empirical Formula and Molecular Weight Acidity/alkalinity Strongly alkaline; pH = 11.4 (1% w/v aqueous
Na2CO3 105.99 solution at 258C).(5)
Na2CO3H2O 124.0 Hygroscopicity One mole of sodium carbonate will gradually
Na2CO310H2O 286.1 absorb 1 mole of water (approximately 15%) on exposure to air.
Melting point 8518C
Refractive index n20 D = 1.3352 at 1.0% w/w solution; 1.3440 at
5 Structural Formula 5.0% w/w solution; 1.3547 for 10.0% w/w solution.(6)
See Section 4. Solubility Freely soluble in water, with solubility initially increas-
ing with temperature and then settling at 30.8% w/w above
808C(5) (see Figure 1). Soluble in glycerin; practically insoluble in
6 Functional Category ethanol (95%).
Alkalizing agent; buffering agent. Specific gravity 2.53

7 Applications in Pharmaceutical Formulation or

Technology
36
Sodium carbonate is used as an alkalizing agent in injectable,
ophthalmic, oral, and rectal formulations.
S
32
Na2CO3 in saturated solution (wt %)

In effervescent tablets or granules, sodium carbonate is used in

combination with an acid, typically citric acid or tartaric acid.(1)
When the tablets or granules come into contact with water, an acid– 28
base reaction occurs in which carbon dioxide gas is produced and
the product disintegrates.(2) Raw materials with low moisture
contents are required to prevent the early triggering of the 24
effervescent reaction.(2)
As an alkalizing agent, concentrations of sodium carbonate 20
between 2% and 5% w/w are used in compressed tablet
formulations.(1,3) As an effervescent agent, concentrations of
sodium carbonate up to 10% w/w can be used.(2) 16
Therapeutically, sodium carbonate is also used as an oral
antacid.(4) 12

8 Description 8
Sodium carbonate is a white, almost white, or colorless inorganic
salt, produced as crystalline powder or granules. It is hygroscopic 4
and odorless with an alkaline taste. 0 20 40 60 80 100
Temperature (°C)
9 Pharmacopeial Specifications
Figure 1: Solubility of sodium carbonate in water.(5) Adapted with
See Table I. permission.

63 5
 6 36 Sodium Carbonate
11 Stability and Storage Conditions
Sodium carbonate converts to the monohydrate form when in
contact with water and produces heat. It begins to lose carbon
dioxide at temperatures above 4008C(7) and decomposes before
boiling. Store in airtight containers.
12 Incompatibilities
Sodium carbonate decomposes when in contact with acids in the
presence of water to produce carbon dioxide and effervescence. It
may react violently with aluminum, phosphorous pentoxide,
sulfuric acid, fluorine, and lithium.
13 Method of Manufacture
Sodium carbonate is produced by the ammonia-soda process, also
known as the Solvay process.(7)
14 Safety
Sodium carbonate is used in injectable, oral, and rectal pharma-
ceutical formulations. The pure form of sodium carbonate is mildly
toxic by ingestion, moderately toxic by inhalation and SC routes,
and very toxic by the IP route. It is irritating to the skin and eyes.
Dust and vapors of sodium carbonate may irritate mucous
membranes, causing coughing and shortness of breath. It also has
experimental reproductive effects.
Sodium carbonate can migrate to food from packaging
materials. When used as an excipient or antacid, sodium carbonate
is generally regarded as a nontoxic and nonirritating material.
LD50 (mouse, IP): 0.12 g/kg(8)
LD50 (mouse, SC): 2.21 g/kg
LD50 (rat, oral): 4.09 g/kg
15 Handling Precautions
Observe normal precautions appropriate to the circumstances and
quantity of the material handled. When heated to decomposition it
emits toxic fumes of sodium oxide. Eye protection and gloves are
recommended. Respiratory protection is also recommended if
inhalable dust is present.
16 Regulatory Status
S GRAS listed. Accepted for use as a food additive in Europe.
Included in the FDA Inactive Ingredients Database (injections;
ophthalmic solution; oral capsules and tablets; rectal suspensions).
Included in the Canadian List of Acceptable Non-medicinal
Ingredients. Included in parenteral (powder for solution for
injection) and nonparenteral medicines (oral effervescent tablets,
soluble tablets, granules, lozenges, chewing gums) licensed in the
UK.
USP32–NF27 allows either the anhydrous or the monohydrate
form.
17 Related Substances
Sodium bicarbonate; sodium carbonate decahydrate; sodium
carbonate monohydrate.
Sodium carbonate decahydrate
Empirical formula Na2CO310H2O
Molecular weight 286.1
CAS number [6132-02-1]
Description Colorless, transparent, or white crystals or powder.
Solubility Freely soluble in water; practically insoluble in ethanol
(95%).
Comments Listed in PhEur 6.0 and JP XV. Used in alkaline
baths.(4)
Sodium carbonate monohydrate
Empirical formula Na2CO3H2O
Molecular weight 124.0
CAS number [5968-11-6]
Description Colorless or white crystals or granules.
Solubility Soluble in 3 parts water, 1.8 parts boiling water, or 7
parts glycerin. Practically insoluble in ethanol (95%). Dries out
in warm dry air or above 508C, and converts to anhydrous form
above 1008C.
Comments Listed in PhEur 6.0 and USP32–NF27. Commonly
used in antacid preparations and as a reagent.(4)
18 Comments
Sodium carbonate is more stable in effervescent formulations than
sodium bicarbonate,(3) but is less effective as an effervescent agent
and therefore sodium bicarbonate is most commonly used in
effervescent formulations.(2) Sodium carbonate can be added to
these formulations as a stabilizing agent (up to 10% w/w) as it
absorbs moisture, preventing early effervescent reactions.(2) This
effect is exploited in Effer-Soda, in which a sodium bicarbonate core
is protected by a surface layer of sodium carbonate, equivalent to
8–12% w/w.(9)
The technical grade of sodium carbonate anhydrous (approxi-
mately 99% purity) is known as soda ash.
A specification for sodium carbonate is contained in the Food
Chemicals Codex (FCC).(10)
The EINECS number for sodium carbonate is 207-838-8. The
PubChem Compound ID (CID) for sodium carbonate is 10340.
19 Specific References
1 Niazi S. Compressed solid dosage formulations. Niazi SK, ed. Hand-
book of Pharmaceutical Manufacturing Formulations, vol. 1: Part II.
Boca Raton FL: CRC Press, 2004.
2 Bertuzzi D. Effervescent granulation. Parikh D, ed. Handbook of
Pharmaceutical Granulation Technology, 2nd edn. Boca Raton FL:
Taylor and Francis, 2005; 365.
3 Badawy S et al. Effect of processing and formulation variables on the
stability of a salt of a weakly basic drug candidate. Pharm Dev Technol
2004; 9: 239–245.
4 Sweetman SC, ed. Martindale: the Complete Drug Reference, 36th edn.
London: Pharmaceutical Press, 2009; 2389.
5 Eggeman T. Sodium carbonate.Kirk-Othmer Encyclopedia of Chemical
Technology, 5th edn, vol. 22: New York: Wiley, 2001; 787–797.
6 Lide DR, ed. CRC Handbook of Chemistry and Physics, 88th edn.
Boca Raton FL: CRC Press/Taylor and Francis, 2008; 8–52.
7 O’Neil MJ, ed. Merck Index: An Encyclopedia of Chemicals, Drugs and
Biologicals, 14th edn. Whitehouse Station NJ: Merck, 2006; 1480–
1481.
8 Lewis RJ, ed. Sax’s Dangerous Properties of Industrial Chemicals, 11th
edn. New York: Wiley, 2004; 3236.
9 SPI Pharma. Technical Bulletin No. 117/0300: Effer-Soda, 2007.
10 Food Chemicals Codex, 6th edn. Bethesda, MD: United States
Pharmacopeia, 2008; 878.
20 General References
—
21 Author
KP Hapgood.
22 Date of Revision
3 March 2009.
 W
Water

1 Nonproprietary Names purified water, water for injection (WFI), sterile water for injection,
BP: Purified Water bacteriostatic water for injection, sterile water for irrigation, or
sterile water for inhalation. Validation is required for all systems
JP: Purified Water
producing the water indicated, with the exception of potable water.
PhEur: Water, Purified The chemical composition of potable water is variable, and the
USP: Purified Water nature and concentrations of the impurities in it depend upon the
See also Sections 8 and 17. source from which it is drawn. Water classified as potable water for
applications such as some initial rinsing and API manufacturing
2 Synonyms operations, must meet the US Environmental Protection Agency’s
National Primary Drinking Water Regulations, or comparable
Aqua; aqua purificata; hydrogen oxide.
regulations of the EU or Japan. For most pharmaceutical applica-
tions, potable water is purified by distillation, ion exchange
3 Chemical Name and CAS Registry Number
treatment, reverse osmosis (RO), or some other suitable process
Water [7732-18-5] to produce ‘purified water’. For certain applications, water with
pharmacopeial specifications differing from those of purified water
4 Empirical Formula and Molecular Weight should be used, e.g. WFI; see Sections 9 and 18.
H2 O 18.02 Water is a clear, colorless, odorless, and tasteless liquid.

5 Structural Formula
See Section 4. 9 Pharmacopeial Specifications
See Table II. See also Section 17.
6 Functional Category
Solvent.

7 Applications in Pharmaceutical Formulation or 10 Typical Properties

Technology Boiling point 1008C
Water is widely used as a raw material, ingredient and solvent in the Critical pressure 22.1 MPa (218.3 atm)
processing, formulation and manufacture of pharmaceutical Critical temperature 374.28C
products, active pharmaceutical ingredients (API) and intermedi- Dielectric constant D 25 = 78.54
ates, and analytical reagents. Specific grades of water are used for Dipole moment
particular applications in concentrations up to 100%; see Table I. 1.76 in benzene at 258C;
1.86 in dioxane at 258C.
Table I: Typical applications of specific grades of water. Ionization constant 1.008  1014 at 258C.
Latent heat of fusion 6 kJ/mol (1.436 kcal/mol)
Type Use
Latent heat of vaporization 40.7 kJ/mol (9.717 kcal/mol)
Bacteriostatic water for injection Diluent for ophthalmic and multiple- Melting point 08C
dose injections. Refractive index n20 D = 1.3330
Potable water Public supply suitable for drinking, Solubility Miscible with most polar solvents.
the purity of which is unlikely to be
suitable for use in the manufacture
Specific gravity 0.9971 at 258C.
of pharmaceuticals. Specific heat (liquid) 4.184 J/g/8C (1.00 cal/g/8C) at 148C.
Purified water Vehicle and solvent for the Surface tension 71.97 mN/m (71.97 dynes/cm) at 258C.
manufacture of drug products and Vapor pressure 3.17 kPa (23.76 mmHg) at 258C.
W pharmaceutical preparations; not
suitable for use in the manufacture
Viscosity (dynamic) 0.89 mPa s (0.89 cP) at 258C.

of parenteral products.
Sterile water for inhalation Diluent for inhalation therapy
products.
11 Stability and Storage Conditions
Sterile water for injection Diluent for injections.
Sterile water for irrigation Diluent for internal irrigation therapy Water is chemically stable in all physical states (ice, liquid, and
products. vapor). Water leaving the pharmaceutical purification system and
Water for injections in bulk Water for the bulk preparation of entering the storage tank must meet specific requirements. The goal
medicines for parenteral
when designing and operating the storage and distribution system is
administration.
to keep the water from exceeding allowable limits during storage. In
particular, the storage and distribution system must ensure that
water is protected against ionic and organic contamination, which
8 Description would lead to an increase in conductivity and total organic carbon,
The term ‘water’ is used to describe potable water that is freshly respectively. The system must also be protected against physical
drawn direct from the public supply and is suitable for drinking. entry of foreign particles and microorganisms so that microbial
Water used in the pharmaceutical industry and related disciplines is growth is prevented or minimized. Water for specific purposes
classified as either drinking (potable) water, purified water, sterile should be stored in appropriate containers; see Table III.

7 66
 Table II: Pharmacopeial specifications of water for different pharmaceutical applications.

Test Water Purified Purified Purified Purified Water, Sterile Bacteriostatic Sterile Sterile Sterile Water for Water for Water for Sterile Sterile
JP XV water water in water in water highly water for water for water for water for purified injection(a) injection injection water for purified
JP XV bulk containers USP 32 purified injection injection inhalation irrigation water JP XV USP 32 (in bulk) injection water
PhEur 6.3 PhEur 6.3 PhEur 6.3 USP 32 USP 32 USP 32 USP 32 USP 32 PhEur 6.3 PhEur 6.3 JP XV
Identification — — — — — — — — — — — — — — — —
Production — — þ — — þ — — — — — — — þ — —
Characters — — þ þ — þ — — — — — — — þ — —
Appearance of solution — þ — — — — — — — — — — — — — þ
Odor and taste — þ — — — — — — — — — — — — — þ
pH — — — — — — 5.0–7.0 4.5–7.0 — — — — — — — —
Acid or alkali — þ — þ — — — — — — — þ — — þ þ
Cadmium — — — — — — — — — — — — — — — —
Chloride — þ — þ — — þ — — — — — þ — þ þ
Cyanide — — — — — — — — — — — — — — — —
Copper — — — — — — — — — — — — — — — —
Sulfate — þ — þ — — þ þ — — — þ — — þ þ
Ammonium 40.05 mg/L 40.05 mg/L — 40.2 ppm — — þ — — — — þ — — 40.2 ppm 40.05 mg/L
Iron — — — — — — — — — — — — — — — —
Calcium — — — þ — — þ þ — — — — — — þ —
Lead — — — — — — — — — — — — — — — —
Magnesium — — — þ — — — — — — — — — — þ —
Aluminum — — 410 ppb — — 410 ppb — — — — — — — 410 ppb 410 ppb —
Nitrate — — 40.2 ppm — — 40.2 ppm — — — — — — — 40.2 ppm 40.2 ppm þ
Nitrogen from nitrate — þ — — — — — — — — — þ — — — þ
Nitrogen from nitrite — þ — — — — — — — — — þ — — — þ
Carbon dioxide — — — — — — þ þ — — — — — — — —
Heavy metals — þ 40.1 ppm — — — — — — — — þ — — — þ
Oxidizable substances — — þ þ — — þ — þ þ þ — — — þ —
Potassium — þ — — — — — — — — — þ — — — þ
permanganate-
reducing substances
Residue on evaporation — 41.0 mg — 40.001% — — — — — — — þ — — þ 41.0 mg
Total organic carbon — — þ — þ 40.5 mg/L — — — — — þ(b) þ 40.5 mg/L — —
Total hardness — — — — — — — — — — — — — — — —
Conductivity — — þ — þ þ — — 425 mS/cm for 425 mS/cm for 425 mS/cm — þ þ 425 mS/cm for —
containers containers for containers containers
410 mL, 410 mL, 410 mL, 410 mL,
45 mS/cm 45 mS/cm 45 mS/cm for 45 mS/cm
for containers for containers containers for containers
510 ml 510 ml 510 ml 510 ml
Anionic surfactants — — — — — — — — — — — — — — — —
Antimicrobial agents — — — — — — — þ — — — — — — — —
Sterility — — — — — — þ þ þ þ þ þ — — þ þ
Extractable volume — — — — — — — — — — — þ — — — —
Particulate matter — — — — — — þ þ — — — — — — þ —
Microbial contamination — — — 4102 cfu/mL — — — — — — — — — — — —
Bacterial endotoxins — — 40.25 IU/mL — — 40.25 IU/mL 40.25 EU/mL <0.5 EU/mL <0.5 EU/mL 40.25 EU/mL — 40.25 EU/mL 40.25 EU/mL 40.25 IU/mL <0.25 IU/mL —

(a) For water for injection preserved in containers and sterilized, the JP XV provides separate tests for acid or alkali, chloride, ammonium, and residue on evaporation within the monograph.
(b) For water for injection prepared by reverse osmosis–ultrafiltration.

Water
76 7
W
 7 68 Water

Table III: Storage requirements for different grades of water. exchange, RO or any other suitable method that complies with
regulations on water intended for human consumption laid down
Type Storage requirements(a) by the competent authority. The USP 32 and the JP XV permit the
Bacteriostatic water for injection Preserve in single-dose and multiple-
use of RO in addition to distillation and ultrafiltration. In the past
dose containers, preferably of 10–15 years, RO has become the most common way to produce
Type I or Type II glass, not larger pharmaceutical purified water, either as a final treatment step or as a
than 30 mL in size. pretreatment step for the distillation stills.
Potable water Preserve in tightly sealed containers. Distillation Distillation is a process that involves the evaporation
Purified water Preserve in tightly sealed containers. of water followed by the condensation of the resulting steam.
If it is stored in bulk, the conditions While expensive, it allows removal of almost all organic and
of storage should be designed to inorganic impurities and achieves very high quality water. It is
limit the growth of microorganisms
and avoid any other also considered the safest method to avoid microbial and
contamination. endotoxin contamination. To improve energy efficiency, distilla-
Sterile water for inhalation Preserve in single-dose containers, tion is usually conducted in multiple-effects stills designed to
preferably of Type I or Type II recover most of the energy spent on evaporating the water. A
glass. typical design consists of an evaporator, vapor separator, and
Sterile water for injection Preserve in single-dose containers, compressor. The distilland (raw feed water) is heated in the
preferably of Type I or Type II evaporator to boiling and the vapor produced is separated from
glass, not more than 1000 mL in
entrained distilland in the separator. The vapor then enters a
size.
Water for injection Preserve in tightly sealed containers. compressor where the temperature of the vapors is raised to
Water for injections in bulk Collect and store in conditions 1078C. Superheated vapors are then condensed on the outer
designed to prevent growth of surface of the tubes of the evaporator containing cool distilland
microorganisms and avoid any circulating within.
other contamination. Vapor compression stills of various sizes are commercially
available and can be used to produce water of high purity when
(a) To prevent evaporation and to maintain quality.
properly constructed. A high-quality distillate, such as WFI, can
be obtained if the water is first deionized. The best stills are
constructed from types 304 or 316 stainless steel and coated with
12 Incompatibilities pure tin, or are made from chemical-resistant glass.
In pharmaceutical formulations, water can react with drugs and Deionization An ionic exchange process is based on the ability of
other excipients that are susceptible to hydrolysis (decomposition in certain synthetic resins to selectively adsorb either cations or
the presence of water or moisture) at ambient and elevated anions, and to release (exchange) other ions based on their
temperatures. relative activity. Cationic and anionic ion exchange resins are
Water can react violently with alkali metals and rapidly with used to purify potable water by removing any dissolved ions.
alkaline metals and their oxides, such as calcium oxide and Dissolved gases are also removed, while chlorine, in the
magnesium oxide. Water also reacts with anhydrous salts to form concentrations generally found in potable water, is destroyed
hydrates of various compositions, and with certain organic by the resin itself. Some organics and colloidal particles are
materials and calcium carbide. removed by adsorption and filtration. Resin beds may, however,
foster microbial life and produce pyrogenic effluent unless
13 Method of Manufacture adequate precautions are taken to prevent contamination.
Unlike other excipients, water is not purchased from outside Another disadvantage is the type of chemicals required for resin
suppliers but is manufactured in-house by pharmaceutical compa- regeneration. A continuous deionization system, which repre-
nies. As naturally occurring water has a variety of contaminants, sents a combination of ion exchange and membrane separation
many treatment processes have been developed to remove these. A technologies, uses an electrical current to continuously regener-
typical pharmaceutical water purification system contains several ate the ion exchange resin simultaneously with the water
unit operations designed to remove various components. The treatment process, eliminating the need to handle powerful
selection of the most appropriate system and its overall design are chemicals. Ion exchange units are normally used today to treat
crucial factors in ensuring that water of the correct quality is raw feed water prior to distillation or RO processing.
produced.(1,2) Reverse osmosis Water is forced through a semipermeable
To produce potable or drinking water, insoluble matter is first membrane in the opposite direction to normal osmotic diffusion.
W removed from a water supply by coagulation, settling (clarifica-
tion), and filtering processes. Pathogenic microorganisms present
Typically, membranes range between 1–10 Å and reject not only
organic compounds, bacteria and viruses, but also 90–99% of
are then destroyed by aeration, chlorination, or some other means. all ions. It is common to use double-pass RO systems with two
Water may also be rendered free of viable pathogenic microorgan- filtration stages connected in series. Such systems meet require-
isms by active boiling for 15–20 minutes. Activated carbon filters ments for USP purified water and WFI. However, EU regulations
are employed to remove chlorine and many dissolved organic do not allow RO to be used as a final treatment step for the
materials found in water, although they may become a breeding production of WFI.
ground for microorganisms. The palatability of the water is Membrane filtration Membrane filters are surface-type filters,
improved by aeration and charcoal filtration. which stop particles larger than the pore size at the upstream
Purified water suitable for use in pharmaceutical formulations is surface of the polymeric membrane. Microfiltration uses
usually prepared by purifying potable water by one of several membranes with pores in the 0.1–1.0 mm range, which can filter
processes, such as distillation, deionization, or RO.(1,3–8) out particles of dust, activated carbon, ion exchange resin fines,
The quality attributes of WFI are stricter than those for purified and most microorganisms. Ultrafiltration uses membranes that
water. Consequently, the preparation methods typically vary in the reject not only solid particles but also dissolved matter with a
last stage to ensure good control of WFI quality. Methods for the high molecular weight. The ‘molecular weight cut-off’ point of
production of WFI are the subject of current debate. The PhEur 6.3 such membranes varies in the range 10 000–100 000 Da, and
indicates that only distillation would give assurance of consistent bacteria, endotoxins, colloidal contaminants, and large organic
supply of the appropriate quality, but permits distillation, ion molecules can be removed.
 Water 76 9

14 Safety Sterile water for irrigation

Water is the base for many biological life forms, and its safety in
pharmaceutical formulations is unquestioned provided it meets
standards of quality for potability(9) and microbial content; see
Sections 9 and 18. Plain water is considered slightly more toxic
upon injection into laboratory animals than physiological salt
solutions such as normal saline or Ringer’s solution.
Ingestion of excessive quantities of water can lead to water
intoxication, with disturbances of the electrolyte balance.
WFI should be free from pyrogens.
LD50 (mouse, IP): 25 g/kg(10)
Comments The USP 32 describes sterile water for irrigation as
WFI sterilized and suitably packaged. It contains no antimicro-
bial agents or other substances.
Water for injection (WFI)
Comments The USP 32 describes WFI as water purified by
distillation or RO. It contains no added substances. The PhEur
6.3 title is ‘water for injections’ and comprises two parts: ‘water
for injections in bulk’ and ‘sterilized water for injection’. The
PhEur 6.3 states that water for injections is produced by
distillation.

18 Comments
15 Handling Precautions
In most pharmacopeias, the term ‘water’ now refers to purified or
Observe normal precautions appropriate to the circumstances and distilled water.
quantity of material handled. Without further purification, ‘water’ may be unsuitable for
certain pharmaceutical applications; for example, the presence of
calcium in water affects the viscosity and gel strength of algins and
16 Regulatory Status
pectin dispersions, while the use of potable water affects the clarity
Included in nonparenteral and parenteral medicines licensed in the and quality of cough mixtures, and the stability of antibiotic liquid
UK and USA. preparations.
Water commonly contains salts of aluminum, calcium, iron,
magnesium, potassium, sodium, and zinc. Toxic substances such as
17 Related Substances arsenic, barium, cadmium, chromium, cyanide, lead, mercury, and
Bacteriostatic water for injection; carbon dioxide-free water; de- selenium may constitute a danger to health if present in excessive
aerated water; hard water; soft water; sterile water for inhalation; amounts. Ingestion of water containing high amounts of calcium
sterile water for injection; sterile water for irrigation; water for and nitrate is also contraindicated. National standards generally
injection (WFI). specify the maximum limits for these inorganic substances in
Bacteriostatic water for injection potable water. Limits have also been placed on microorganisms,
Comments The USP 32 describes bacteriostatic water for injection detergents, phenolics, chlorinated phenolics, and other organic
as sterile water for injection that contains one or more suitable substances. The WHO(11) and national bodies have issued guide-
antimicrobial agents. lines for water quality, although many countries have their own
standards for water quality embodied in specific legislation.(12) See
Carbon dioxide-free water Table IV.
Comments Purified water that has been boiled vigorously for 5
minutes and allowed to cool while protecting it from absorption
of atmospheric carbon dioxide. Table IV: Limits for inorganic substances in potable water (mg/L).

De-aerated water Contaminant UK (mg/L) WHO (mg/L)

Comments Purified water that has been boiled vigorously for 5 Aluminum 0.2 0.2
minutes and cooled to reduce the air (oxygen) content. Ammonium 0.5 —
Hard water Antimony 0.01 —
Arsenic 0.05 0.05
Comments Water containing the equivalent of not less than Barium 1.0 No limit
120 mg/L and not more than 180 mg/L of calcium carbonate. Beryllium — No limit
Soft water Boron 2.0 —
Cadmium 0.005 0.005
Comments Water containing the equivalent of not more than
Calcium 250 —
60 mg/L of calcium carbonate. Chloride 400 250
Sterile water for inhalation
Comments The USP 32 describes sterile water for inhalation as
Chromium
Copper
Cyanide
0.05
3.0
0.05
0.05
1.0
0.1
W
WFI sterilized and suitably packaged. It contains no antimicro- Fluoride 1.5 1.5
bial agents or other added substances, except where used in Iron 0.2 0.3
humidifiers or other similar devices, and where liable to Lead 0.05 0.05
contamination over a period of time. Magnesium 50 —
Manganese 0.05 0.1
Sterile water for injection Mercury 0.001 0.001
Comments The USP 32 describes sterile water for injection as WFI Nickel 0.05 No limit
sterilized and suitably packaged. It contains no antimicrobial Nitrate (as N) — 10
agents or other substances. Nitrate (as NO3) 50 —
Sterile water for injection in containers is one of the materials Nitrite (as NO2) 0.1 —
Phosphorus 2.2 —
that have been selected for harmonization by the Pharmacopeial Potassium 12 —
Discussion Group. For further information see the General Selenium 0.01 0.01
Information Chapter <1196> in the USP32–NF27, the General Silver 0.01 No limit
Chapter 5.8 in PhEur 6.0, along with the ‘State of Work’ Sodium 150 200
document on the PhEur EDQM website, and also the General Sulfate 250 400
Information Chapter 8 in the JP XV. Zinc 5.0 5.0
 7 70 Wax, Anionic Emulsifying
Control of microbiological contamination is critical for waters
used in preparation of pharmaceuticals, as proliferation of
microorganisms can potentially occur during all stages of manu-
facture, storage, or distribution. Suitable control is achieved by
ensuring that the water system is well designed and well maintained.
Purified water that is produced, stored, and circulated at ambient
temperatures is susceptible to the establishment of biofilms;
therefore, frequent monitoring, high usage, correct flow rate, and
appropriate sanitization are all factors that require consideration to
ensure that water is satisfactory.(13)
Monitoring of the whole system is essential in order to
demonstrate that correct microbiological quality is achieved. For
WFI, the recommended methodology is membrane filtration
(0.45 mm) as a large sample size (100–300 mL) is required. For
purified water, membrane filtration or plate count methods are
typically used depending on the quality requirements of the system.
It is important to set appropriate target, alert, and action limits to
serve as an indication of action required to bring the quality of
water back under control. It is recognized that limits are not
intended as pass/fail criteria for water or product batches; however,
an investigation regarding the implications should be conducted.(14)
Validation is conducted to provide a high level of assurance that
the water production and distribution system will consistently
produce water conforming to a defined quality specification. The
validation process serves to qualify the design (DQ), installation
(IQ), operation (OQ), and performance (PQ) of the system. The
extent of monitoring data required should be defined, with
consideration given to whether validation to FDA guidelines is
required.(14) It is also important to have an ongoing control
program with respect to maintenance, and periodic reviews of the
performance of the water system.
The PubChem Compound ID (CID) for water is 962.
19 Specific References
1 Thomas WH, Harvey H. Achieving purity in pharmaceutical water.
Manuf Chem Aerosol News 1976; 47(10): 32, 36, 39, 40.
2 McWilliam AJ. High purity water distribution systems. Pharm Eng
1995; Sept/Oct: 54–71.
3 Honeyman T. Purified water for pharmaceuticals. Manuf Chem 1987;
58(3): 53, 54, 57, 59.
4 Cross J. Treating waters for the pharmaceutical industry. Manuf Chem
1988; 59(3): 34–35.
Wax, Anionic Emulsifying
W
1 Nonproprietary Names
BP: Emulsifying Wax
PhEur: Cetostearyl Alcohol (Type A), Emulsifying
PhEur: Cetostearyl Alcohol (Type B), Emulsifying
2 Synonyms
Collone HV; Crodex A; Cyclonette Wax; Lanette SX; Lanette W.
3 Chemical Name and CAS Registry Number
Anionic emulsifying wax [8014-38-8]
5 Cross J. Steam sterilisable ultrafiltration membranes. Manuf Chem
1989; 60(3): 25–27.
6 Horry JM, Cross JR. Purifying water for ophthalmic and injectable
preparations. Pharm J 1989; 242: 169–171.
7 Smith VC. Pure water. Manuf Chem 1990; 61(3): 22–24.
8 Burrows WD, Nelson JH. IV fluidmakers: preparation of sterile water
for injection in a field setting. J Parenter Sci Technol 1993; 47(3): 124–
129.
9 Walker A. Drinking water – doubts about quality. Br Med J 1992; 304:
175–178.
10 Lewis RJ, ed. Sax’s Dangerous Properties of Industrial Materials, 11th
edn. New York: Wiley, 2004; 3692.
11 World Health Organization. Guidelines for Drinking-water Quality,
vol. 1: Recommendations. Geneva: WHO, 1984.
12 Statutory Instrument 1147. The water supply (water quality) regula-
tions 1989. London: HMSO, 1989. http://www.opsi.gov.uk/ (accessed
27 February 2009).
13 Riedewald F. Biofilms in pharmaceutical waters. Pharm Eng 1997;
Nov/Dec: 8–18.
14 Food and Drug Administration. Guide to Inspections of High Purity
Water Systems. Washington, DC: FDA, 1993. http://www.fda.gov/ora/
inspect_ref/igs/high.html (accessed 27 February 2009).
20 General References
Collentro WV, ed. Pharmaceutical Water: System Design, Operation and
Validation. Buffalo Grove, IL: Interpharm Press, 1999.
European Directorate for the Quality of Medicines and Healthcare
(EDQM). European Pharmacopoeia – State Of Work Of International
Harmonisation. Pharmeuropa 2009; 21(1): 142–143. http://www.edq-
m.eu/site/-614.html (accessed 27 February 2009).
Rössler R. Water and air, two important media in the manufacture of sterile
pharmaceuticals, with regard to the GMP. Drugs Made Ger 1976; 19:
130–136.
Santoro M, Maini C. Which water for pharmaceutical use? Eur J Parenter
Pharm Sci 2003; 8: 15–20.
21 Authors
D Dubash, U Shah.
22 Date of Revision
27 February 2009.
4 Empirical Formula and Molecular Weight
The PhEur 6.2 specifies that cetostearyl alcohol (type A), emulsify-
ing contains a minimum of 80% cetostearyl alcohol and 7% sodium
cetostearyl sulfate. Cetostearyl alcohol (type B), emulsifying
contains a minimum of 80% cetostearyl alcohol and 7% sodium
lauryl sulfate. A suitable buffer can be added to both.
The BP 2009 describes anionic emulsifying wax as containing
cetostearyl alcohol, purified water, and either sodium lauryl sulfate
or a sodium salt of a similar sulfated higher primary aliphatic
alcohol. See also Section 18.
The BP 2009 specifies that the formula of anionic emulsifying
wax is:
Cetostearyl alcohol 90 g
Sodium lauryl sulfate 10 g
Purified water 4 mL
 Sodium Carbonate, Anhydrous
Safety Data Sheet
according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations
Date of issue: 05/13/2013 Revision date: 03/20/2018 Supersedes: 03/20/2018 Version: 1.2

SECTION 1: Identification
1.1. Identification
Product form : Substance
Substance name : Sodium Carbonate, Anhydrous
CAS-No. : 497-19-8
Product code : LC22965
Formula : Na2CO3
1.2. Recommended use and restrictions on use
Use of the substance/mixture : For laboratory and manufacturing use only.
Recommended use : Laboratory chemicals
Restrictions on use : Not for food, drug or household use
1.3. Supplier
LabChem Inc
Jackson's Pointe Commerce Park Building 1000, 1010 Jackson's Pointe Court
Zelienople, PA 16063 - USA
T 412-826-5230 - F 724-473-0647
info@labchem.com - www.labchem.com

1.4. Emergency telephone number

Emergency number : CHEMTREC: 1-800-424-9300 or +1-703-741-5970

SECTION 2: Hazard(s) identification

2.1. Classification of the substance or mixture
GHS-US classification
Skin corrosion/irritation H315 Causes skin irritation
Category 2
Serious eye damage/eye H319 Causes serious eye irritation
irritation Category 2A
Full text of H statements : see section 16

2.2. GHS Label elements, including precautionary statements

GHS-US labeling
Hazard pictograms (GHS-US) :

GHS07
Signal word (GHS-US) : Warning
Hazard statements (GHS-US) : H315 - Causes skin irritation
H319 - Causes serious eye irritation
Precautionary statements (GHS-US) : P264 - Wash exposed skin thoroughly after handling.
P280 - Wear eye protection, protective gloves.
P302+P352 - IF ON SKIN: Wash with plenty of soap and water.
P305+P351+P338 - If in eyes: Rinse cautiously with water for several minutes. Remove contact
lenses, if present and easy to do. Continue rinsing
P332+P313 - If skin irritation occurs: Get medical advice/attention.
P337+P313 - If eye irritation persists: Get medical advice/attention.
P362 - Take off contaminated clothing and wash before reuse.
2.3. Other hazards which do not result in classification
Other hazards not contributing to the : None.
classification
2.4. Unknown acute toxicity (GHS US)
Not applicable

03/20/2018 EN (English US) Page 1

Sodium Carbonate, Anhydrous
Safety Data Sheet
according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations

SECTION 3: Composition/Information on ingredients

3.1. Substances
Substance type : Mono-constituent
Name Product identifier % GHS-US classification
Sodium Carbonate, Anhydrous (CAS-No.) 497-19-8 100 Skin Irrit. 2, H315
(Main constituent) Eye Irrit. 2A, H319
Full text of hazard classes and H-statements : see section 16
3.2. Mixtures
Not applicable
SECTION 4: First-aid measures
4.1. Description of first aid measures
First-aid measures general : Never give anything by mouth to an unconscious person. If you feel unwell, seek medical
advice (show the label where possible).
First-aid measures after inhalation : Allow victim to breathe fresh air. Allow the victim to rest.
First-aid measures after skin contact : Wash with plenty of soap and water. Wash contaminated clothing before reuse. If skin irritation
occurs: Get medical advice/attention. Get medical advice/attention.
First-aid measures after eye contact : Rinse immediately with plenty of water. Obtain medical attention if pain, blinking or redness
persists.
First-aid measures after ingestion : Rinse mouth. Do NOT induce vomiting. Obtain emergency medical attention.
4.2. Most important symptoms and effects (acute and delayed)
Symptoms/effects after inhalation : Coughing.
Symptoms/effects after skin contact : Causes skin irritation.
Symptoms/effects after eye contact : Causes serious eye irritation.
Symptoms/effects after ingestion : Vomiting. Nausea.
Chronic symptoms : Not available.
4.3. Immediate medical attention and special treatment, if necessary
None.

SECTION 5: Fire-fighting measures

5.1. Suitable (and unsuitable) extinguishing media
Suitable extinguishing media : Foam. Dry powder. Carbon dioxide. Water spray. Sand.
Unsuitable extinguishing media : Do not use a heavy water stream.
5.2. Specific hazards arising from the chemical
Fire hazard : Non combustible.
Explosion hazard : Not applicable.
Reactivity : Reacts with (some) acids.
5.3. Special protective equipment and precautions for fire-fighters
Firefighting instructions : Use water spray or fog for cooling exposed containers. Exercise caution when fighting any
chemical fire. Prevent fire-fighting water from entering environment.
Protection during firefighting : Do not enter fire area without proper protective equipment, including respiratory protection.

SECTION 6: Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures
General measures : None.

6.1.1. For non-emergency personnel

Emergency procedures : Evacuate unnecessary personnel.

6.1.2. For emergency responders

Protective equipment : Equip cleanup crew with proper protection.
Emergency procedures : Ventilate area.
6.2. Environmental precautions
Prevent entry to sewers and public waters. Notify authorities if liquid enters sewers or public waters.

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Sodium Carbonate, Anhydrous
Safety Data Sheet
according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations

6.3. Methods and material for containment and cleaning up

Methods for cleaning up : On land, sweep or shovel into suitable containers. Minimize generation of dust. Store away
from other materials.
6.4. Reference to other sections
See Heading 8. Exposure controls and personal protection.

SECTION 7: Handling and storage

7.1. Precautions for safe handling
Precautions for safe handling : Wash hands and other exposed areas with mild soap and water before eating, drinking or
smoking and when leaving work. Provide good ventilation in process area to prevent formation
of vapor.
Hygiene measures : Wash exposed skin thoroughly after handling.
7.2. Conditions for safe storage, including any incompatibilities
Storage conditions : Keep only in the original container in a cool, well ventilated place away from : incompatible
materials. Keep container closed when not in use.
Incompatible products : Strong bases. Strong acids.
Incompatible materials : Sources of ignition. Direct sunlight.

SECTION 8: Exposure controls/personal protection

8.1. Control parameters
No additional information available

8.2. Appropriate engineering controls

Appropriate engineering controls : Emergency eye wash fountains should be available in the immediate vicinity of any potential
exposure.

8.3. Individual protection measures/Personal protective equipment

Personal protective equipment:
Gloves. Safety glasses.

Hand protection:
Wear protective gloves.

Eye protection:
Chemical goggles or safety glasses

Skin and body protection:

Wear suitable protective clothing

Respiratory protection:
Respiratory protection not required in normal
conditions

Other information:
Do not eat, drink or smoke during use.

SECTION 9: Physical and chemical properties

9.1. Information on basic physical and chemical properties
Physical state : Solid
Appearance : White powder or lumps.
Color : white

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Sodium Carbonate, Anhydrous
Safety Data Sheet
according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations

Odor : odorless
Odor threshold : No data available
pH : 11.6
Melting point : No data available
Freezing point : No data available
Boiling point : 1600 °C
Flash point : No data available
Relative evaporation rate (butyl acetate=1) : No data available
Flammability (solid, gas) : Non flammable.
Vapor pressure : No data available
Relative vapor density at 20 °C : No data available
Relative density : No data available
Specific gravity / density : 2.53 g/cm³
Molecular mass : 105.99 g/mol
Solubility : No data available
Log Pow : No data available
Auto-ignition temperature : No data available
Decomposition temperature : No data available
Viscosity, kinematic : No data available
Viscosity, dynamic : No data available
Explosion limits : No data available
Explosive properties : Not applicable.
Oxidizing properties : None.
9.2. Other information
No additional information available

SECTION 10: Stability and reactivity

10.1. Reactivity
Reacts with (some) acids.
10.2. Chemical stability
Not established.
10.3. Possibility of hazardous reactions
Not established.
10.4. Conditions to avoid
Direct sunlight. Extremely high or low temperatures.
10.5. Incompatible materials
Strong acids. Strong bases.
10.6. Hazardous decomposition products
fume. Carbon monoxide. Carbon dioxide.

SECTION 11: Toxicological information

11.1. Information on toxicological effects

Likely routes of exposure : Inhalation; Skin and eye contact

Acute toxicity : Not classified
Sodium Carbonate, Anhydrous (497-19-8)
LD50 oral rat 4090 mg/kg
ATE US (oral) 4090 mg/kg body weight
Skin corrosion/irritation : Causes skin irritation.
pH: 11.6

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Sodium Carbonate, Anhydrous
Safety Data Sheet
according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations

Serious eye damage/irritation : Causes serious eye irritation.

pH: 11.6
Respiratory or skin sensitization : Not classified
Germ cell mutagenicity : Not classified
Based on available data, the classification criteria are not met
Carcinogenicity : Not classified
Reproductive toxicity : Not classified
Based on available data, the classification criteria are not met
Specific target organ toxicity – single exposure : Not classified
Specific target organ toxicity – repeated : Not classified
exposure
Aspiration hazard : Not classified

Potential Adverse human health effects and : Based on available data, the classification criteria are not met.
symptoms
Symptoms/effects after inhalation : Coughing.
Symptoms/effects after skin contact : Causes skin irritation.
Symptoms/effects after eye contact : Causes serious eye irritation.
Symptoms/effects after ingestion : Vomiting. Nausea.
Chronic symptoms : Not available.

SECTION 12: Ecological information

12.1. Toxicity
Sodium Carbonate, Anhydrous (497-19-8)
LC50 fish 1 300 mg/l
EC50 Daphnia 1 265 mg/l
LC50 fish 2 740 mg/l

12.2. Persistence and degradability

Sodium Carbonate, Anhydrous (497-19-8)
Persistence and degradability Not established.

12.3. Bioaccumulative potential

Sodium Carbonate, Anhydrous (497-19-8)
Bioaccumulative potential Not established.

12.4. Mobility in soil

No additional information available

12.5. Other adverse effects

Other information : Avoid release to the environment.

SECTION 13: Disposal considerations

13.1. Disposal methods
Waste disposal recommendations : Dispose in a safe manner in accordance with local/national regulations.
Ecology - waste materials : Avoid release to the environment.

SECTION 14: Transport information

Department of Transportation (DOT)
In accordance with DOT
Not regulated

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Sodium Carbonate, Anhydrous
Safety Data Sheet
according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations

SECTION 15: Regulatory information

15.1. US Federal regulations
Sodium Carbonate, Anhydrous (497-19-8)
Listed on the United States TSCA (Toxic Substances Control Act) inventory
All components of this product are listed, or excluded from listing, on the United States Environmental Protection Agency Toxic
Substances Control Act (TSCA) inventory

15.2. International regulations

CANADA
Sodium Carbonate, Anhydrous (497-19-8)
Listed on the Canadian DSL (Domestic Substances List)

EU-Regulations
No additional information available

National regulations
Sodium Carbonate, Anhydrous (497-19-8)
Listed on the Canadian IDL (Ingredient Disclosure List)

15.3. US State regulations

California Proposition 65 - This product does not contain any substances known to the state of California to cause cancer,
developmental and/or reproductive harm

SECTION 16: Other information

Revision date : 03/20/2018
Other information : None.
Full text of H-phrases: see section 16:
--- H315 Causes skin irritation
---
--- H319 Causes serious eye irritation
---
NFPA health hazard : 1 - Materials that, under emergency conditions, can cause
significant irritation.
NFPA fire hazard : 0 - Materials that will not burn under typical dire conditions,
including intrinsically noncombustible materials such as
concrete, stone, and sand.
NFPA reactivity : 0 - Material that in themselves are normally stable, even
under fire conditions.

Hazard Rating
Health : 1 Slight Hazard - Irritation or minor reversible injury possible
Flammability : 0 Minimal Hazard - Materials that will not burn
Physical : 0 Minimal Hazard - Materials that are normally stable, even under fire conditions, and will NOT
react with water, polymerize, decompose, condense, or self-react. Non-Explosives.
Personal protection : B
B - Safety glasses, Gloves

SDS US LabChem

Information in this SDS is from available published sources and is believed to be accurate. No warranty, express or implied, is made and LabChem Inc assumes no liability resulting from the use of this
SDS. The user must determine suitability of this information for his application.

03/20/2018 EN (English US) 6/6

 CD63S2013/02

Teepol Products, Murray Road, Orpington Kent BR5 3QY

T: 01689 877020 F: 01689 877027 E: sales@teepol.co.uk

SAFETY DATA SHEET

Revision date: 24/02/2017 Version no 3

Print date: 24/02/2017

SECTION 1: IDENTIFICATION OF SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING

1.1 Product identifiers
Trade Name Description Unit Code
Teepol Multi Purpose Detergent 4 x 5L 0001
Teepol Multi Purpose Detergent 20 L Drum 0002
Teepol Multi Purpose Detergent 200 L Drum 0003
Teepol Multi Purpose Detergent 1000 L IBC 0029
Teepol Multi Purpose Detergent 6 x 1L Squirt 0032
Teepol Multi Purpose Detergent 12 x 500ml 0554
1.2 Relevant identified uses of the substance/mixture and uses advised against
Detergent for washing up and general cleaning.
1.3 Details of the supplier of the safety data sheet
Company Teepol Products,
Address Harvey Waddington, Telephone 01689 877020
Murray Road, Fax 01689 877027
Orpington,
Kent BR5 3QY E-Mail sales@teepol.co.uk

1.4 Emergency telephone number +44 (0)1689 877020 (09:00 - 16:00 Monday to Friday)
SECTION 2: HAZARD IDENTIFICATION
2.1 Classification of the substance or mixture
Classification according to Regulation (EC) No 1272/2008 [EU-GHS/CLP
Eye. Irrit. 2, H319
Skin. Irrit. 2, H315
2.2 Label elements
Signal Word: Hazard Pictograms:
WARNING
Hazard Statements:

H315 Causes skin irritation.

H319 Causes serious eye irritation.

Precautionary Statements:
Disposal
P501 Dispose of contents/container to licensed waste disposal site.

Product Identifier: Teepol Multi Purpose Detergent Page 1 of 6

Prevention
P264 Wash … thoroughly after handling.

Response
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and
easy to do. Continue rinsing.
P302 + P352 IF ON SKIN: Wash with plenty of soap and water.
P332 + P313 If skin irritation occurs: Get medical advice/attention.

Storage
P102 Keep out of reach of children.
2.3 Other hazards
EUH none None known

SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS

3.2. Mixtures
Substance Name REACH Reg. No. CAS-No EC-No. Amount [%]
Sodium Dodecylbenzene Sulphonate 01-2119565112-48-XXXX 25155-30-0 246-680-4 5-15
Hazard Class Hazard Category Hazard Statements
Skin corrosion/irritation Skin. Irrit. 2 H315 Skin corrosion/irritation
Serious eye damage/irritation Eye. Dam. 1 H318 Serious eye damage/irritation
Substance Name REACH Reg. No. CAS-No EC-No. Amount [%]
Sodium C12-C15 Alcohol Ether Sulphate 13150-00-0 236-091-0 <5
Hazard Class Hazard Category Hazard Statements
Skin corrosion/irritation Skin. Irrit. 2 H315 Skin corrosion/irritation
Serious eye damage/irritation Eye. Dam. 1 H318 Serious eye damage/irritation

SECTION 4: FIRST AID MEASURES

4.1 Description of first aid measures
General Advice
Remove contaminated clothing.
After inhalation
Ensure supply of fresh air
After contact with skin
Rinse off with water
After contact with eyes
Rinse eyes with water until irritation subsides.
After ingestion:
If small amount wash out mouth with water and drink clean water. If amount is large give plenty of water to drink, do
not induce vomiting and seek medical advise.
4.2 Most important symptoms and effects, both acute and delayed
Eye irritation and reddening
4.3 Indication of any immediate medical attention and special treatment needed
Rinse with clean water
SECTION 5: FIRE-FIGHTING MEASURES
5.1 Suitable extinguishing media: This product is not flammable. Use fire extinguishing media appropriate for
surrounding area.
5.1 Unsuitable extinguishing media: Not applicable.
5.2 Special hazards arising from the substance or mixture
Product Identifier: Teepol Multi Purpose Detergent Page 2 of 6
5.2 Special hazards arising from the substance or mixture
May produce oxides of carbon, nitrogen, sodium and sulphur.
5.3 Advice fo Fire Fighters
Wear self-contained breathing apparatus and protective clothing as appropriate to the associated fire.
SECTION 6: ACCIDENTAL RELEASE MEAS
6.1 Personal precautions, protective equipment and emergency procedures
Use appropriate PPE. Avoid breathing vapours if any and ensure adequate ventilation. Cordon off area to other
personnel.
6.2 Environmental precaution
Do not allow to enter surface water drains, soil/subsoil.
6.3 Methods and material for containment and cleaning up
Absorb with sand or binder and dispose of according to local regulations. Small spillages may be flushed to a foul
drain.
6.4 Reference to Other Sections: See Section 8 and 13 for more information on exposure and disposal.
SECTION 7: HANDLING and STORAGE
7.1 Precautions for safe handling
Provide good ventilation in working area. Wash hands after use and do not allow to enter surface water drains.
7.2 Conditions for safe storage, including any incompatabilities
Store only in original containers out of reach of children. Storage temperature should be between 5'C and 30'C.
7.3 Specific end use(s)
Use only as directed on the container or label.
SECTION 8: EXPOSURE CONTROLS / PERSONAL PROTECTION
8.1 Control paramenters
Contains no substances with known occupational exposure limits.
8.2 Exposure Controls
Do not eat, drink or smoke whilst working and wash hands after use.
Exposure Controls - Eyes: Avoid contact with eyes.
Exposure Controls - Skin: Wear vinyl, latex or nitrile gloves.
Exposure Controls - Respiratory None required.
SECTION 9: PHYSICAL and CHEMICAL PROPERTIES
9.1 Information on basic physical and chemical properties
Appearance / Odour Green liquid with Lemon odour (Method: QP22)
pH (10% soln.) 6.5-7.5 (Method: QP03)
Melting/freezing point: 0'C
Flammable / Flash point Not Flammable
Relative density 1.02 g/cm3 @ 20'C (Method: QP07)
Solubility: Soluble/dispersible in water
Viscosity: 60 - 70s Ford 4 @20'C (Method: QP04)
Oxidising properties: Not applicable.
Explosive properties: Not applicable.
9.2 Other Information No information available.
SECTION 10: STABILITY AND REACTIVITY
10.1 Reactivity: Not known to react with other chemicals
10.2 Chemical Stability: No stability concerns
10.3 Hazardous Reactions: None known
10.6 Hazardous Decomposition Products May produce toxic products of combustion when invoved with a fire.
10.4 Conditions to Avoid: None known
10.5 Incompatible Materials: None known

SECTION 11: TOXICOLOGICAL INFORMATION

11.1 Information on toxicological effects
Product Identifier: Teepol Multi Purpose Detergent Page 3 of 6
11.1 Information on toxicological effects
Substance Toxicity
Sodium Acute toxicity
Dodecylbenzene LD50 Oral - rat - 438 mg/kg
Sulphonate Remarks: Sense Organs and Special Senses (Nose, Eye, Ear, and Taste):Eye:Lacrimation.
Behavioral:Somnolence (general depressed activity). Diarrhoea
Skin corrosion/irritation
Skin - rabbit - Skin irritation - 24 h
Serious eye damage/eye irritation
Eyes - rabbit - Severe eye irritation - 24 h
Respiratory or skin sensitization
no data available
Germ cell mutagenicity
no data available
Carcinogenicity
IARC: No component of this product present at levels greater than or equal to 0.1% is identified as
probable, possible or confirmed human carcinogen by IARC.
Reproductive toxicity
no data available
Specific target organ toxicity - single exposure
Inhalation - May cause respiratory irritation.
Specific target organ toxicity - repeated exposure
no data available

Aspiration hazard
no data available
Potential health effects
Inhalation May be harmful if inhaled. Causes respiratory tract irritation.
Ingestion Harmful if swallowed.
Skin May be harmful if absorbed through skin. Causes skin irritation.
Eyes Causes eye burns.
Signs and Symptoms of Exposure
To the best of our knowledge, the chemical, physical, and toxicological properties have not been
thoroughly investigated.
Additional Information
RTECS: DB6825000
Sodium C12-C15 TOXIC DOSE 1 - LD 50 >2000 mg/kg (oral rat)
Alcohol Ether INHALATION
Sulphate May cause irritation to the respiratory system.
INGESTION
May cause discomfort if swallowed.
SKIN CONTACT
Irritating to skin.
EYE CONTACT
May cause severe irritation to eyes.
No information regarding interactions between the ingredients in this mixture is available, therefore, the information shown
above is separately reported for each relevant ingredient used in the mixture even though it may be present below its
concentration limit and represent no toxicity in the mixture as a whole.

SECTION 12: ECOLOGICAL INFORMATION

No specific information is available for this mixture, therefore, the following information regarding the relevant substances used
in this mixture is provided, even though they may be present below the concentration limit and represent minimal or no toxicity
to the environment.
Substance ECO Toxicity
Sodium 12.1 Toxicity
Dodecylbenzene Fish mortality NOEC - Oncorhynchus kisutch -3.1 mg/l - 3d
Sulphonate mortality LOEC - Oncorhynchus kisutch - 5.6 mg/l - 3d
Toxicity to daphnia and other aquatic invertebrates
mortality NOEC - Daphnia - 4 mg/l - 7d
Product Identifier: Teepol Multi Purpose Detergent Page 4 of 6
Sodium 12.2 Persistence and degradability
Dodecylbenzene no data available
Sulphonate 12.3 Bioaccumulative potential
Bioaccumulation Lepomis macrochirus - 28 d -64 μg/l
Bioconcentration factor (BCF): 220
12.4 Mobility in soil
no data available
12.5 Results of PBT and vPvB assessment
no data available
12.6 Other adverse effects
Avoid release to the environment.
No data available
Sodium C12-C15 12.1 Toxicity
Alcohol Ether EC 50, 48 Hrs, DAPHNIA, mg/l 1-10
Sulphate IC 50, 72 Hrs, ALGAE, mg/l 1-10
12.2 Persistance and degradability:
The product is easily biodegradable.
SECTION 13: DISPOSAL CONSIDERATIONS
13.1 Waste treatment methods
When disposing of surplus or waste product use suitable PPE etc. ensuring empty containers are rinsed out and
disposed of safely. Do not allow product to enter land or surface water drains. Dispose of in accordance with local
authority regulations. Do not mix with other waste materials.
SECTION 14: TRANSPORT INFORMATION
14.1 UN number: N/A
14.2 Shipping Name: Teepol Multi Purpose Detergent
14.3 Transport hazard class None
: N/A
14.4 Packing group:
14.5 Environmental Hazards: None
14.6 Special precautions for user:
No information
14.7 Transport in bulk according to Annex II of Marpol 73/78 and the IBC code:
No information

SECTION 15: REGULATORY INFORMATION

15.1 Safety, health and environment regulation/legislation specific to the substance or mixture

EU Legislation

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling
and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
Regulation (EC) No 1907/2006.

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration,
Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending
Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well
as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, including
amendments.

Guidance

ECHA Guidance on the application of CLP criteria (Version 4: November 2013)

ECHA Guidance on the compilation of safety data sheets (Version 2.1: February 2014)
15.2 Chemical safety assessment
No information
SECTION 16: OTHER INFORMATION
Full text of H-Statements referred to under section 3
H318
Product Identifier: Teepol Multi Purpose Detergent Page 5 of 6
H318 Causes serious eye damage.
H315 Causes skin irritation.
Conforms to Mat. Spec.: MIL-D-16791G Type 1. Nato No. 7930 99 224 5066. ICN Code: 3402 90 90.
Directions:
Dish Washing: 1 part to 600 parts of hot water. General Cleaning: 1 part to 250 parts of hot water. Vehicles: 1 part to 450 parts of warm water. Rinse and dry hands after
use. If you have damaged or sensitive skin, avoid prolonged contact with the neat product or dilute solution. If accidentally splashed into eyes rinse well with cold water.
Further Information: The latest version of this data sheet may be obtained from the Harvey Waddington Web Site at: www.teepol.co.uk

GLOSSARY: PPE Personal protective equipment. N/A Not applicable. N/K Not known OES Occupational exposure limit
TWA Time weighted average W/V Weight to volume

The data contained in this Safety Data Sheet has been supplied for the purpose of protecting the health and safety of industrial and commercial users who are deemed capable of understanding and acting on the information
provided.
ANIMAL TESTING: Teepol Products (UK) do not test their finished products on animals.

The information contained in this document is based on information believed to be correct on the date of issue. No warranty or representation, expressed or
implied, is made as to the accuracy or completeness of this information. The user assumes all liability for any damage or injury resulting from abnormal use, from
the failure to adhere to recommended practises, or from hazards inherent in the nature of the product. In accordance with our policy of incorporating technical
improvemets, we reserve the right to amend any specification without notice.

Product Identifier: Teepol Multi Purpose Detergent Page 6 of 6

 Material Safety Data Sheet
Alcohol 70%
Section 1: Chemical Product and Company Identification

Product Name: OneMed Alcohol 70% Contact Information:

CAS #: Mixtures PT. Jayamas Medica Industri

RTECS: Not Applicable By Pass Krian KM-28

TSCA: TSCA 8(b) inventory; Water; Ethyl Alcohol 95% Sidoarjo - Indonesia

CI#: N/A Telp: +62 31 8982349 ; 8985269

Synonim: - Fax: +62 31 8985268

Chemical Formula: N/A Email: jmi@onemedhealthcare.com

Website: www.onemed.co.id

Section 2: Composition and Information on Ingredients

Composition:
Name CAS # % by Weight
Water 7732-18-5 27
Ethyl alcohol 95% 64-17-5 73

Toxicological Data on Ingredients: Ethyl alcohol: ORAL (LD50): Acute: 7060 mg/kg [Rat]. 3450 mg/kg [Mouse].
VAPOR (LC50): Acute: 20000 ppm 8 hours [Rat]. 39000 mg/m 4 hours [Mouse].

Section 3: Hazards Identification

Potential Acute Health Effects:
Hazardous in case of skin contact (irritant), of eye contact (irritant), . Slightly hazardous in case of skin contact
(permeator), of ingestion. Non-corrosive for skin. Non-corrosive to the eyes. Non-corrosive for lungs.

Potential Chronic Health Effects:

Slightly hazardous in case of skin contact (sensitizer)
CARCINOGENIC EFFECTS: Classified PROVEN
Classified A4 (Not classifiable for human or animal.)
MUTAGENIC EFFECTS: Mutagenic for mammalian somatic cells. [Ethyl alcohol 95% ]. Mutagenic for
bacteria and/or yeast. [Ethyl alcohol 95% ].
TERATOGENIC EFFECTS: Classified PROVEN for human [Ethyl alcohol 95% )
ELOPMENTAL TOXICITY: Classified Development toxin [PROVEN] [Ethyl alcohol 95% ) . Classified
Reproductive system/toxin/female, Reproductive system/toxin/male [POSSIBLE] [Ethyl alcohol 95% ].

p. 1
 The substance is toxic to blood, the reproductive system, liver, upper respiratory tract, skin, central nervous

Section 4: First Aid Measures

Eye Contact:
Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes,
keeping eyelids open. Cold water may be used. Get medical attention.

Skin Contact:
In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove
contaminated clothing and shoes. Cold water may be used.Wash clothing before reuse. Thoroughly clean shoes
before reuse. Get medical attention.

Serious Skin Contact:

Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek medical
attention.

Inhalation:
If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get
medical attention if symptoms appear.

Serious Inhalation:
Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or
waistband. If breathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth
resuscitation. Seek medical attention.

Ingestion:
Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an
unconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention if
symptoms appear.

Serious Ingestion: Not available.

Section 5: Fire and Explosion Data

Flammability of the Product: Flammable.

Auto-Ignition Temperature: The lowest known value is 363°C (685.4°F) (Ethyl alcohol 95% ).

Flash Points: CLOSED CUP: 18.5°C (65.3°F).(estimated)

Flammable Limits: The greatest known range is LOWER: 3.3% UPPER: 19% (Ethyl alcohol 95% )

Products of Combustion: These products are carbon oxides (CO, CO2).

Fire Hazards in Presence of Various Substances:

Highly flammable in presence of open flames and sparks, of heat.
Slightly flammable to flammable in presence of oxidizing materials.
Non-flammable in presence of shocks, of reducing materials, of combustible materials, of organic materials, of
metals, of acids, of alkalis.

Explosion Hazards in Presence of Various Substances:

Slightly explosive in presence of open flames and sparks, of heat, of oxidizing materials, of acids.
Non-explosive in presence of shocks.

Fire Fighting Media and Instructions:

Flammable liquid, soluble or dispersed in water.
SMALL FIRE: Use DRY chemical powder.
LARGE FIRE: Use alcohol foam, water spray or fog.

p. 2
 Special Remarks on Fire Hazards:
Containers should be grounded. CAUTION: MAY BURN WITH NEAR INVISIBLE FLAME Vapor may travel
considerable distance to source of ignition and flash back. May form explosive mixtures with air.
Contact with Bromine pentafluoride is likely to cause fire or explosion.
Ethanol ignites on contact with chromyl chloride.
Ethanol ignites on contact with iodine heptafluoride gas.
It ignites than explodes upon contact with nitrosyl perchlorate.
Additon of platinum black catalyst caused ignition.
(Ethyl alcohol 95% )

Remarks on Explosion Hazards:

Ethanol has an explosive reaction with the oxidized coating around potassium metal.
Ethanol ignites and then explodes on contact with acetic anhydride + sodium hydrosulfate (ignites and may
explode), disulfuric acid + nitric acid, phosphorous(III) oxide platinum, potassium-tert-butoxide+ acids.
Ethanol forms explosive products in reaction with the following
compound : ammonia + silver nitrate (forms silver nitride and silver fulminate), iodine + phosphorus (forms ethane
iodide), magnesium perchlorate (forms ethyl perchlorate), mercuric nitrate, nitric acid + silver (forms silver
fulminate) silver nitrate (forms ethyl nitrate) silver(I) oxide + ammonia or hydrazine (forms
silver nitride and silver fulminate), sodium (evolves hydrogen gas).
Sodium Hydrazide + alcohol can produce an explosion.
Alcohols should not be mixed with mercuric nitrate, as explosive mercuric fulminate may be formed.
May form explosive mixture with manganese perchlorate + 2,2-dimethoxypropane.
Addition of alcohols to highly concentrate hydrogen peroxide forms powerful explosives.
Explodes on contact with calcium hypochlorite
Vapor may explode if ignited in an enclosed area.
Containers may explode when heated or involved in a fire.
(Ethyl alcohol 95% )

Section 6: Accidental Release Measures

Small Spill:
Dilute with water and mop up, or absorb with an inert dry material and place in an appropriate waste disposal
container.

Large Spill:
Flammable liquid.
Keep away from heat. Keep away from sources of ignition. Stop leak if without risk. Absorb with DRY earth,
sand or other non-combustible material. Do not touch spilled material. Prevent entry into sewers, basements or
confined areas; dike if needed. Be careful that the product is not present at a concentration level above TLV.
Check TLV on the MSDS and with local authorities.

Section 7: Handling and Storage

Precautions:
Keep locked up.. Keep away from heat. Keep away from sources of ignition. Ground all equipment containing
material. Do not ingest. Do not breathe gas/fumes/ vapor/spray. Wear suitable protective clothing. In case of
insufficient ventilation, wear suitable respiratory equipment. If ingested, seek medical advice immediately and
show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as
oxidizing agents, acids, alkalis, moisture.

Storage:
Store in a segregated and approved area. Keep container in a cool, well-ventilated area. Keep container tightly
closed and sealed until ready for use. Avoid all possible sources of ignition (spark or flame). Do not store above
23°C (73.4°F).

Section 8: Exposure Controls/Personal Protection

Engineering Controls:

p. 3
 Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their
respective threshold limit value. Ensure that eyewash stations and safety showers are proximal to the
work-station location.

Personal Protection:
Splash goggles. Lab coat. Vapor respirator. Be sure to use an approved/certified respirator or equivalent.
Gloves.

Personal Protection in Case of a Large Spill:

Splash goggles. Full suit. Vapor respirator. Boots. Gloves. A self contained breathing apparatus should be
used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist
BEFORE handling this product.

Exposure Limits:
Ethyl alcohol 200 Proof
TWA: 1900 (mg/m3) from OSHA (PEL) [United States]
TWA: 1000 (ppm) from OSHA (PEL) [United States]
TWA: 1900 (mg/m3) from NIOSH [United States]
TWA: 1000 (ppm) from NIOSH [United States]
TWA: 1000 (ppm) [United Kingdom (UK)]
TWA: 1920 (mg/m3) [United Kingdom (UK)]
TWA: 1000 STEL: 1250 (ppm) [Canada]
Consult local authorities for acceptable exposure limits.

Section 9: Physical and Chemical Properties

Physical state and appearance: Liquid.

Odor:
Alcohol like. Mild to strong. Like wine or
whiskey; Ethereal, vinous. Pleasant.

Taste: Burning. Pungent.

Molecular Weight: Not applicable.

Color: Clear Colorless.

pH (1% soln/water): Neutral.

Boiling Point: The lowest known value is 78.5°C (173.3°F) (Ethyl alcohol 95% ). Weighted average: 79.58°C (175.2°F)

Melting Point: May start to solidify at -114.1°C (-173.4°F) based on data for: Ethyl alcohol 95% ) .

Critical Temperature: The lowest known value is 243°C (469.4°F) (Ethyl alcohol 95% ).

Specific Gravity: Weighted average: 0.8 (Water = 1)

Vapor Pressure: The highest known value is 5.7 kPa (@ 20°C) (Ethyl alcohol 95% ). Weighted average: 5.53 kPa (@
20°C)

Vapor Density: The highest known value is 1.59 (Air = 1) (Ethyl alcohol 95% ). Weighted average: 1.54 (Air = 1)

Volatility: Not available.

Odor Threshold: 100 ppm

Water/Oil Dist. Coeff.: Not available.

Ionicity (in Water): Not available.

p. 4
Dispersion Properties: See solubility in water, methanol, diethyl ether, acetone.

Solubility:
Easily soluble in cold water, hot water, methanol, diethyl ether.
Soluble in acetone.

Section 10: Stability and Reactivity Data

Stability: The product is stable.

Instability Temperature: Not available.

Conditions of Instability: Incompatible materials, heat, sources of ignition.

Incompatibility with various substances: Reactive with oxidizing agents, acids, alkalis.

Corrosivity: Non-corrosive in presence of glass.

Special Remarks on Reactivity:

Ethanol rapidly absorbs moisture from the air.
Can react vigorously with oxiders.
The following oxidants have been demonstrated to undergo vigorous/explosive reaction with ethanol: barium
perchlorate, bromine pentafluoride, calcium hypochlorite, chloryl perchlorate, chromium trioxide, chromyl chloride,
dioxygen difluoride, disulfuryl difluoride, fluorine nitrate, hydrogen peroxide, iodine heptafluoride, nitric acid nitrosyl
perchlorate, perchloric acid permanganic acid, peroxodisulfuric acid, potassium dioxide, potassium perchlorate,
potassium permanganate, ruthenium(VIII) oxide, silver perchlorate, silver peroxide, uranium hexafluoride, uranyl
perchlorate.
Ethanol reacts violently/expodes with the following compounds: acetyl bromide (evolves hydrogen bromide)
acetyl chloride, aluminum, sesquibromide ethylate, ammonium hydroxide & silver oxide, chlorate, chromic
anhydride, cyanuric acid + water, dichloromethane + sulfuric acid + nitrate (or) nitrite, hydrogen peroxide +
sulfuric acid, iodine + methanol + mercuric oxide, manganese perchlorate + 2,2-dimethoxy propane,
perchlorates, permanganates + sulfuric acid, potassium superoxide, potassium tert-butoxide, silver & nitric acid,
silver perchlorate, sodium hydrazide, sulfuric acid + sodium dichromate, tetrachlorisilane + water.
Ethanol is also incompatible with platinium, and sodium.
No really safe conditions exist under which ethyl alcohol and chlorine oxides can be handled.
Reacts vigorously with acetyl chloride (Ethyl alcohol 95% )

Special Remarks on Corrosivity: Not available.

Polymerization: Will not occur.

Section 11: Toxicological Information

Routes of Entry: Absorbed through skin. Eye contact. Inhalation. Ingestion.

Toxicity to Animals: Acute oral toxicity (LD50): 3632 mg/kg (Mouse) (Calculated value for the mixture).

Chronic Effects on Humans:

CARCINOGENIC EFFECTS: Classified PROVEN
Classified A4 (Not classifiable for human or animal.) by ACGIH [Ethyl alcohol 95% ].
MUTAGENIC EFFECTS: Mutagenic for mammalian somatic cells. [Ethyl alcohol 95% ]. Mutagenic for
bacteria and/or yeast. [Ethyl alcohol 95% ].
TERATOGENIC EFFECTS: Classified PROVEN for human [Ethyl alcohol 95% ].
DEVELOPMENTAL TOXICITY: Classified Development toxin [PROVEN] [Ethyl alcohol 95% ]. Classified
Reproductive system/toxin/female, Reproductive system/toxin/male [POSSIBLE] [Ethyl alcohol 95% ].

Other Toxic Effects on Humans:

Hazardous in case of skin contact (irritant), of inhalation.
Slightly hazardous in case of skin contact (permeator), of ingestion.

p. 5
Special Remarks on Toxicity to Animals:
Lowest Published Dose/Conc:
LDL[Human] - Route: Oral; Dose: 1400 mg/kg
LDL[Human child] - Route: Oral; Dose: 2000 mg/kg
LDL[Rabbit] - Route: Skin; Dose: 20000 mg/kg (Ethyl alcohol 95% )

Special Remarks on Chronic Effects on Humans:

May affect genetic material (mutagenic)
Causes adverse reproductive effects and birth defects (teratogenic) , based on moderate to heavy consumption.
May cause cancer based on animal data.
Human: passes through the placenta, excreted in maternal milk. (Ethyl alcohol 95% )

Special Remarks on other Toxic Effects on Humans:

Acute potential health effects:
Skin: causes skin irritation
Eyes: causes eye irritation
Ingestion: May cause gastrointestinal tract irritation with nausea, vomiting, diarrhea, and alterations in gastric
secretions. May affect behavior/central nervous system (central nervous system depression - amnesia,
headache, muscular incoordination, excitation, mild euphoria, slurred speech, drowsiness, staggaring gait, fatigue,
changes in mood/personality, excessive talking, dizziness, ataxia, somnolence, coma/narcosis, hallucinations,
distorted perceptions, general anesthetic), peripherial nervous system (spastic paralysis)vision (diplopia).
Moderately toxic and narcotic in high concentrations. May also affect metabolism, blood, liver, respiration
(dyspnea), and endocrine system.
May affect respiratory tract, cardiovascular(cardiac arrhythmias, hypotension), and urinary systems.
Inhalation: May cause irritation of the respiratory tract and affect behavior/central nervous system with symptoms
similar to ingestion.
Chronic Potential Health Effects:
Skin: Prolonged or repeated skin contact may casue dermatitis, an allergic reaction.
Ingestion: Prolonged or repeated ingestion will have similiar effects as acute ingestion. It may also affect the
brain. (Ethyl alcohol 95% )

Section 12: Ecological Information

Ecotoxicity: Not available.

BOD5 and COD: Not available.

Products of Biodegradation:
Possibly hazardous short term degradation products are not likely. However, long term degradation products may
arise.

Toxicity of the Products of Biodegradation: The product itself and its products of degradation are not toxic.

Special Remarks on the Products of Biodegradation: Not available.

Section 13: Disposal Considerations

Waste Disposal:
Waste must be disposed of in accordance with federal, state and local environmental
control regulations.

Section 14: Transport Information

DOT Classification: CLASS 3: Flammable liquid.

Identification: : Ethanol (Ethyl alcohol 95% ) UNNA: 1170 PG: II

Special Provisions for Transport: Not available.

p. 6
 Section 15: Other Regulatory Information
Other Regulations: OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200).

Other Classifications:

WHMIS (Canada):
CLASS B-2: Flammable liquid with a flash point lower than 37.8°C (100°F).
CLASS D-2B: Material causing other toxic effects (TOXIC).

DSCL (EEC):
R11- Highly flammable.
S7- Keep container tightly closed.
S16- Keep away from sources of ignition - No
smoking.

HMIS (U.S.A.):

Health Hazard: 2

Fire Hazard: 3

Reactivity: 0

Personal Protection: h

National Fire Protection Association (U.S.A.):

Health: 2

Flammability: 3

Reactivity: 0

Specific hazard:

Protective Equipment:
Gloves.
Lab coat.
Vapor respirator. Be sure to use an
approved/certified respirator or
equivalent. Wear appropriate respirator
when ventilation is inadequate.
Splash goggles.

Section 16: Other Information

References: Not available.

Other Special Considerations: Not available.

Created: 10/09/2005 05:28 PM

Last Updated: 11/06/2008 12:00 PM

The information above is believed to be accurate and represents the best information currently available to us. However, we
make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we
assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the
information for their particular purposes.

p.7
 He a lt h 0
0 0
Fire
0 0
Re a c t iv it y 0
P e rs o n a l A
P ro t e c t io n

Material Safety Data Sheet

Water MSDS

Section 1: Chemical Product and Company Identification

Product Name: Water Contact Information:

Catalog Codes: SLW1063 Sciencelab.com, Inc.
14025 Smith Rd.
CAS#: 7732-18-5 Houston, Texas 77396
RTECS: ZC0110000 US Sales: 1-800-901-7247
International Sales: 1-281-441-4400
TSCA: TSCA 8(b) inventory: Water
Order Online: ScienceLab.com
CI#: Not available.
CHEMTREC (24HR Emergency Telephone), call:
Synonym: Dihydrogen oxide 1-800-424-9300
Chemical Name: Water International CHEMTREC, call: 1-703-527-3887
Chemical Formula: H2O For non-emergency assistance, call: 1-281-441-4400

Section 2: Composition and Information on Ingredients

Composition:

Name CAS # % by Weight

Water 7732-18-5 100

Toxicological Data on Ingredients: Not applicable.

Section 3: Hazards Identification

Potential Acute Health Effects:

Non-corrosive for skin. Non-irritant for skin. Non-sensitizer for skin. Non-permeator by skin. Non-irritating to the eyes. Non-
hazardous in case of ingestion. Non-hazardous in case of inhalation. Non-irritant for lungs. Non-sensitizer for lungs. Non-
corrosive to the eyes. Non-corrosive for lungs.
Potential Chronic Health Effects:
Non-corrosive for skin. Non-irritant for skin. Non-sensitizer for skin. Non-permeator by skin. Non-irritating to the eyes.
Non-hazardous in case of ingestion. Non-hazardous in case of inhalation. Non-irritant for lungs. Non-sensitizer for lungs.
CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available.
DEVELOPMENTAL TOXICITY: Not available.

Section 4: First Aid Measures

Eye Contact: Not applicable.

p. 1
Skin Contact: Not applicable.
Serious Skin Contact: Not available.
Inhalation: Not applicable.
Serious Inhalation: Not available.
Ingestion: Not Applicable
Serious Ingestion: Not available.

Section 5: Fire and Explosion Data

Flammability of the Product: Non-flammable.

Auto-Ignition Temperature: Not applicable.
Flash Points: Not applicable.
Flammable Limits: Not applicable.
Products of Combustion: Not available.
Fire Hazards in Presence of Various Substances: Not applicable.
Explosion Hazards in Presence of Various Substances: Not Applicable
Fire Fighting Media and Instructions: Not applicable.
Special Remarks on Fire Hazards: Not available.
Special Remarks on Explosion Hazards: Not available.

Section 6: Accidental Release Measures

Small Spill: Mop up, or absorb with an inert dry material and place in an appropriate waste disposal container.
Large Spill: Absorb with an inert material and put the spilled material in an appropriate waste disposal.

Section 7: Handling and Storage

Precautions: No specific safety phrase has been found applicable for this product.
Storage: Not applicable.

Section 8: Exposure Controls/Personal Protection

Engineering Controls: Not Applicable

Personal Protection: Safety glasses. Lab coat.
Personal Protection in Case of a Large Spill: Not Applicable
Exposure Limits: Not available.

Section 9: Physical and Chemical Properties

Physical state and appearance: Liquid.

p. 2
Odor: Odorless.
Taste: Not available.
Molecular Weight: 18.02 g/mole
Color: Colorless.
pH (1% soln/water): 7 [Neutral.]
Boiling Point: 100°C (212°F)
Melting Point: Not available.
Critical Temperature: Not available.
Specific Gravity: 1 (Water = 1)
Vapor Pressure: 2.3 kPa (@ 20°C)
Vapor Density: 0.62 (Air = 1)
Volatility: Not available.
Odor Threshold: Not available.
Water/Oil Dist. Coeff.: Not available.
Ionicity (in Water): Not available.
Dispersion Properties: Not applicable
Solubility: Not Applicable

Section 10: Stability and Reactivity Data

Stability: The product is stable.

Instability Temperature: Not available.
Conditions of Instability: Not available.
Incompatibility with various substances: Not available.
Corrosivity: Not available.
Special Remarks on Reactivity: Not available.
Special Remarks on Corrosivity: Not available.
Polymerization: Will not occur.

Section 11: Toxicological Information

Routes of Entry: Absorbed through skin. Eye contact.

Toxicity to Animals:
LD50: [Rat] - Route: oral; Dose: > 90 ml/kg LC50: Not available.
Chronic Effects on Humans: Not available.
Other Toxic Effects on Humans:
Non-corrosive for skin. Non-irritant for skin. Non-sensitizer for skin. Non-permeator by skin. Non-hazardous in case of
ingestion. Non-hazardous in case of inhalation. Non-irritant for lungs. Non-sensitizer for lungs. Non-corrosive to the eyes. Non-
corrosive for lungs.
Special Remarks on Toxicity to Animals: Not available.

p. 3
Special Remarks on Chronic Effects on Humans: Not available.
Special Remarks on other Toxic Effects on Humans: Not available.

Section 12: Ecological Information

Ecotoxicity: Not available.

BOD5 and COD: Not available.
Products of Biodegradation:
Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.
Toxicity of the Products of Biodegradation: The product itself and its products of degradation are not toxic.
Special Remarks on the Products of Biodegradation: Not available.

Section 13: Disposal Considerations

Waste Disposal:
Waste must be disposed of in accordance with federal, state and local environmental control regulations.

Section 14: Transport Information

DOT Classification: Not a DOT controlled material (United States).

Identification: Not applicable.
Special Provisions for Transport: Not applicable.

Section 15: Other Regulatory Information

Federal and State Regulations: TSCA 8(b) inventory: Water

Other Regulations: EINECS: This product is on the European Inventory of Existing Commercial Chemical Substances.
Other Classifications:
WHMIS (Canada): Not controlled under WHMIS (Canada).
DSCL (EEC):
This product is not classified according to the EU regulations. Not applicable.
HMIS (U.S.A.):
Health Hazard: 0
Fire Hazard: 0
Reactivity: 0
Personal Protection: a
National Fire Protection Association (U.S.A.):
Health: 0
Flammability: 0
Reactivity: 0
Specific hazard:

p. 4
Protective Equipment:
Not applicable. Lab coat. Not applicable. Safety glasses.

Section 16: Other Information

References: Not available.

Other Special Considerations: Not available.
Created: 10/10/2005 08:33 PM
Last Updated: 05/21/2013 12:00 PM

The information above is believed to be accurate and represents the best information currently available to us. However, we
make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume
no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for
their particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or for
lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.com
has been advised of the possibility of such damages.

p. 5
 Hydrochloric Acid MSDS
Effective Date: December 03, 2012
24 Hour Emergency Contact:
ChemTel: (800)255-3924
www.pioneerforensics.com

1. PRODUCT AND COMPANY IDENTIFICATION

Product: Hydrochloric Acid

Product Number(s): PF021, PF022
CAS#: 7647-01-0
Synonyms: Muriatic acid; Hydrogen chloride, aqueous; Chlorohydric acid
Manufacturer: Pioneer Forensics, LLC
804 E. Eisenhauer Blvd.
Loveland, CO 80537
Ph: (970) 292-8487
Emergency Number: (800) 255-3924 (CHEM-TEL)
Customer Service: (970) 292-8487

2. HAZARDS IDENTIFICATION

Emergency Overview: DANGER! Corrosive. Causes severe skin, eye, and digestive tract burns. Harmful if
swallowed. Mist or vapor extremely irritating to eyes and respiratory tract.

Safety Ratings: Health: 3, Severe Reactivity: 1, Slight

Flammability: 0, None Contact: 4, Extreme

OSHA Regulatory Status: This product is considered a "Hazardous Chemical" as defined by the OSHA Hazard
Communication Standard, 29 CFR 1910.1200.

Potential Acute Health Effects:

Routes of Exposure: Inhalation, ingestion, skin contact, eye contact

Inhalation: Corrosive. May cause damage to mucous membranes in nose, throat, lungs and bronchial
system.

Ingestion: Corrosive. Harmful if swallowed. May produce burns to the lips, oral cavity, upper airway,
esophagus and digestive tract.

Skin Contact: Corrosive. Causes severe burns.

Eye Contact: Corrosive. Causes severe burns. Vapor or spray may cause eye damage, impaired sight or
blindness.

Target Organs: Skin, respiratory system, eyes, lungs

Chronic Health Effects: Corrosive. Prolonged contact causes serious tissue damage.

Product: Hydrochloric Acid

Revision Date: 12/03/2012 1/7
Aggravation of: Repeated or prolonged exposure to the substance can produce target organs damage.
Medical Conditions: Persons with pre-existing skin disorders or eye problems may be more susceptible to the
effects of the substance.

Potential Environmental May affect the acidity (pH) in water with risk of harmful effects to aquatic organisms.
Effects:

3. COMPOSITION AND INFORMATION ON INGREDIENTS

Chemical Formula % by
Components CAS# Formula Weight Hazardous Weight
Hydrochloric Acid 7647-01-0 HCl 36.46 Yes 36.5 - 38.0
Water 7732-18-5 H2O 18.02 No 62.0 - 63.5

4. FIRST AID MEASURES

First Aid Procedures:

Inhalation: Remove to fresh air. If breathing is difficult, administer oxygen. If the victim is not
breathing, perform mouth-to-mouth resuscitation. Get medical attention immediately.

Ingestion: Do not induce vomiting. If vomiting occurs, keep head low so that vomit does not enter
lungs. Never give anything by mouth to an unconscious person. GET MEDICAL
ATTENTION IMMEDIATELY.

Skin Contact: Flush affected area with plenty of water for at least 15 minutes. Remove contaminated
clothing and shoes. Wash clothing before reuse. Get medical attention immediately.

Eye Contact: Check for and remove contact lenses. Immediately flush eyes with gentle but large stream
of water for at least 15 minutes, lifting lower and upper eyelids occasionally. Get medical
attention immediately.

General Advice: In the case of accident or if you feel unwell, seek medical advice immediately (show the
label where possible). Ensure that medical personnel are aware of the material(s) involved
and take precautions to protect themselves. Show this safety data sheet to the doctor in
attendance.

Notes to Physician: Treat symptomatically. Keep victim under observation.

5. FIRE FIGHTING MEASURES

NFPA Ratings: Health: 3 Flammability: 0 Reactivity: 1

Flammable Properties: The material is not flammable.

Flash Point: Not applicable

Auto-ignition Temp: Not applicable

Flammable Limits in Not applicable

Air (% by volume):

Suitable Extinguishing Media: Water, dry powder, foam, carbon dioxide

Unsuitable Extinguishing Media: No information found

Product: Hydrochloric Acid

Revision Date: 12/03/2012 2/7
Hazardous Combustion
Products:
Specific Hazards:
Special Protective Equipment
For Firefighters:
Specific Methods:
6. ACCIDENTAL RELEASE MEASURES
Personal Precautions:
Environmental Precautions:
Methods for Containment:
Methods for Cleaning Up:
7. HANDLING AND STORAGE
Handling:
Storage:
8. EXPOSURE CONTROL AND PERSONAL PROTECTION
Exposure Limits:
Engineering Controls:
Product: Hydrochloric Acid
Revision Date: 12/03/2012
Hydrogen chloride. Chlorine. May decompose upon heating to produce corrosive and/or
toxic fumes.
Fire may produce irritating, corrosive, and/or toxic gases.
As in any fire, wear MSHA/NIOSH approved (or equivalent) self-contained positive pressure
or pressure-demand breathing apparatus and full protective gear.
Use water spray to cool unopened containers. Cool containers exposed to flames with
flooding quantities of water until well after the fire is out. In the event of fire and/or explosion
do not breathe fumes.
Ventilate area of leak or spill. Isolate hazard area and keep unnecessary and unprotected
personnel away from the area of the leak or spill. Keep upwind. Keep out of low areas.
Wear appropriate personal protective equipment as specified in the Exposure Control and
Personal Protection Section 8. Avoid contact with eyes, skin, and clothing.
Prevent further leakage or spillage if safe to do so. Do not contaminate water. Avoid
discharge into drains, water courses or onto the ground. In case of large spill, dike if
needed.
Stop the flow of material, if this is without risk. Prevent entry into waterways, sewer,
basements or confined areas. Dike the spilled material, where this is possible.
Absorb spill with an inert material (e.g. vermiculite, dry sand, earth, cloth, fleece), and place
in a suitable non-combustible container for reclamation or disposal. Do not use combustible
materials, such as sawdust. Clean contaminated surface thoroughly. Neutralize spill area
and washings with soda ash or lime. Never return spills in original containers for re-use.
Clean up in accordance with all applicable regulations.
Wear personal protective equipment (see section 8). Use only in well-ventilated areas.
Provide sufficient air exchange and/or exhaust in work rooms. Avoid contact with skin, eyes
and clothing. Do not breathe vapors or spray mist. Do not ingest. When using, do not eat,
smoke, or drink. Keep away from incompatible materials. Handle in accordance with good
industrial hygiene and safety practice. Wash thoroughly after handling. Containers of this
material may be hazardous when empty since they retain product residues (vapors, liquids).
Observe all warnings and precautions listed for the product Use caution when combining
with water. DO NOT add water to acid. ALWAYS add acid to water while stirring to prevent
release of heat, steam, and fumes.
Store in a cool, dry, ventilated area away from incompatible materials. Store in original
container. Keep containers tightly closed and upright. Keep away from food, drink and
animal feedingstuffs. Keep out of the reach of children.
ACGIH: Ceiling: 2 ppm
OSHA: Ceiling: 5 ppm
3
7 mg/m
Ensure adequate ventilation. Ventilation rates should be matched to conditions. If
applicable, use process enclosures, local exhaust ventilation, or other engineering controls
3/7
 to maintain airborne levels below recommended exposure limits. If exposure limits have not
been established, maintain airborne levels to an acceptable level. Explosion proof exhaust
ventilation should be used.

Personal Protective Equipment:

Eye/Face Protection: Wear safety glasses with side shields or goggles and a face shield.

Skin Protection: Wear appropriate chemical resistant clothing (with long sleeves) and appropriate chemical
resistant gloves.

Respiratory Protection: If engineering controls do not maintain airborne concentrations below recommended
exposure limits (where applicable) or to an acceptable level (in countries where exposure
limits have not been established), an approved respirator must be worn. Respirator type:
Chemical respirator with acid gas cartridge. Use a positive-pressure air-supplied respirator
if there is any potential for an uncontrolled release, exposure levels are not known, or any
other circumstances where air-purifying respirators may not provide adequate protection.

General Hygiene Avoid contact with skin, eyes and clothing. When using, do not eat, drink or smoke. Always
Considerations: observe good personal hygiene measures, such as washing after handling the material and
before eating, drinking, and/or smoking. Routinely wash work clothing and protective
equipment to remove contaminants. Provide eyewash station and safety shower.

9. PHYSICAL AND CHEMICAL PROPERTIES

Physical State: Liquid

Appearance: Transparent
Color: Colorless
Odor: Pungent, irritating
Molecular Formula: HCl
Molecular Weight: 36.46
pH: 0.1 (1.0 N Solution)
Specific Gravity: 1.18
Freezing/Melting Point: -25 °C (-13 °F)
Boiling Point: 50.5 °C (123 °F)
Flash Point: Not applicable
Auto Ignition Temperature: Not applicable
Flammable Limits in Air
(% by Volume):
Upper: Not applicable
Lower:
Solubility: Miscible with water
Vapor Pressure: 25 kPa at 25°C (estimate)
Vapor Density: 1.3 (estimate)
Odor threshold (ppm): 0.25-10 ppm
Evaporation Rate: No information found
Partition Coefficient
(n-octanol/water): No information found

10. STABILITY AND REACTIVITY

Stability: Stable under normal conditions.

Conditions to Avoid: Incompatibles

Incompatible Materials: Bases, metals, oxidizing agents, acids, amines, reducing agents, organic materials

Product: Hydrochloric Acid

Revision Date: 12/03/2012 4/7
Hazardous Decomposition Hydrogen chloride, chlorine. May decompose upon heating to product corrosive and/or
Products: toxic fumes.

Possibility of Hazardous Can react vigorously, violently or explosively with incompatible materials listed above.
Reactions:

Hazardous Polymerization: Will not occur.

11. TOXICOLOGICAL INFORMATION

Toxicological Data: Oral Rat LD50: 240 mg/kg (estimate)

Oral Rabbit LD50: 900 mg/kg
Inhalation Rat LC50: 3124 mg/L 1 H

Acute Effects: Strongly corrosive. May cause deep tissue damage. Harmful if swallowed.

Local Effects: Causes severe burns. Mist or vapor extremely irritating to eyes and respiratory tract.

Sensitization: Not a skin sensitizer.

Chronic Effects: Corrosive. Prolonged or repeated skin contact causes serious tissue damage.

Carcinogenic Effects: This product is not considered to be a carcinogen by IARC, ACGIH, NTP, or OSHA.

ACGIH: A4 – Not classifiable as a human carcinogen

IARC: 3 – Not classifiable as to carcinogenicity of humans

Skin Corrosion/Irritation: Corrosive to skin and eyes.

Epidemiology: No epidemiological data is available for this product.

Mutagenicity: No data available to indicate product or any components present at greater than 0.1% are
mutagenic or genotoxic.

Neurological Effects: No information found.

Reproductive Effects: Contains no ingredient listed as toxic to reproduction.

Teratogenic Effects: No data available to indicate product or any components present at greater than 0.1% may
cause birth defects.

Target Organs and Symptoms: Corrosive effects. Mucus membranes, skin, eyes, kidneys, liver, respiratory tract

12. ECOLOGICAL INFORMATION

Ecotoxicological Data: LC50 Western mosquitofish (Gambusia affinis): 282 mg/L 96 H

Ecotoxicity: This product may affect the acidity (pH) in water with risk of harmful effects to aquatic
organisms.

Environmental Effects: An environmental hazard cannot be excluded in the event of unprofessional handling or
disposal.

Persistence and Degradability: Expected to be readily biodegradable.

Product: Hydrochloric Acid

Revision Date: 12/03/2012 5/7
Partition Coefficient No information found.
(n-octanol/water):

13. DISPOSAL INFORMATION

Disposal Instructions: Dispose of this material and its container to hazardous or special waste collection point.
Incinerate the material under controlled conditions in an approved incinerator. All wastes
must be handled in accordance with local, state and federal regulations.

Contaminated Packaging: Since emptied containers retain product residue, follow label warnings even after container
is emptied. Offer rinsed packaging material to local recycling facilities.

Waste Codes: D002: Waste corrosive material (pH ≤ 2 or pH ≥12.5, or corrosive to steel)

14. TRANSPORT INFORMATION

DOT:

UN Number: UN1789

Proper Shipping Name: Hydrochloric Acid

Hazard Class: 8

Packaging Group: II

ERG Number: 157

15. REGULATORY INFORMATION

U.S. Federal Regulations:

OSHA: This product is considered a "Hazardous Chemical" as defined by the OSHA Hazard
Communication Standard, 29 CFR 1910.1200.

TSCA Inventory: Hydrochloric Acid; Water

U.S. EPCRA (SARA Title III):

Sections 311/312: Hazard Categories List (Yes/No)____

Section 311 – Hazardous Chemical Yes
Immediate Hazard Yes
Delayed Hazard No
Fire Hazard No
Pressure Hazard No
Reactivity Hazard No

Section 302: Extremely Hazardous Substance: Hydrochloric Acid

Reportable Quantity: 5000 lbs

Threshold Planning Quantity: 500 lbs

Section 313: Toxic chemical or category: Hydrochloric Acid

Product: Hydrochloric Acid

Revision Date: 12/03/2012 6/7
 De minimis concentration: 1.0%

CERCLA: Hydrochloric Acid: 5000 lbs

International Inventories: Country(s) or Region Inventory Name On Inventory (Yes/No)*

Australia Australian Inventory of Chemical Yes
Substances (AICS)
Canada Domestic Substances List (DSL) Yes
Canada Non-Domestic Substances List (NDSL) No
China Inventory of Existing Chemical Yes
Substances in China (IECSC)
Europe European Inventory of Existing Commercial Yes
Chemical Substances (EINECS)
Europe European List of Notified Chemical No
Substances (ELINCS)
Japan Inventory of Existing and New Chemical Yes
Substances (ENCS)
Korea Existing Chemicals List (ECL) Yes
New Zealand New Zealand Inventory Yes
Philippines Philippine Inventory of Chemicals and Yes
Chemical Substances (PICCS)

*A "Yes" indicates that the listed component(s) of this product comply with the inventory requirements administered by the
governing country(s)

16. OTHER INFORMATION

Product Use: Laboratory and/or field reagent

Disclaimer: Pioneer Forensics LLC provides the information in this Material Safety Data Sheet in the
belief that it is reliable but assumes no responsibility for its completeness or accuracy. The
physical properties reported in this MSDS are obtained from the literature and do not
constitute product specifications. Pioneer Forensics LLC makes and gives no
representations or warranties with respect to the information contained herein or the product
to which it refers, whether express, implied, or statutory, including without limitation,
warranties of accuracy, completeness, merchantability, non-infringement, performance,
safety, suitability, stability, and fitness for a particular purpose. No warranty against
infringement of any patent, copyright or trademark is made or implied. This MSDS is
intended only as a guide to the appropriate handling of the material by a properly trained
person. It shall be the user's responsibility to develop proper methods of handling and
personal protection based on the actual conditions of use. Accordingly, Pioneer Forensics
LLC assumes no liability whatsoever for the use of or reliance upon this information
including results obtained, incidental or consequential damages, or lost profits.

Issue Date: 12/03/2012

Reason for Revision: Not applicable

Product: Hydrochloric Acid

Revision Date: 12/03/2012 7/7