Excipients Role + Specs + MOA + COA's

Genome Pharmaceuticals (Pvt.) Ltd.
16/I, Phase IV , Industrial Estate Hattar Pakistan, Ph# (+92-995) 617872-73 / Fax # (+92-995) 617874
SPECIFICATIONS OF
INACTIVE PHARMACEUTICAL INGREDIENTS
The excipients used in the formula are well established and compendial in British
pharmacopoeia. From the literature it was predicted that the excipients are
compatible with active ingredients and this is conformed from the stability and
assay of the finished product.
All of the excipients are conventional pharmaceutical ingredients comply with

the requirements of the BP. They are included in the formulation at suitable
levels and for recognized purposes. Formulation does not contain any Excipients
of Human or Animal Origin. Novel Excipients were totally avoided. The inactive
ingredients (excipients) which are used in formulation are inert substances. These
ingredients are compatible with the active ingredients and have no harmful or
hazards effects on the finished product or patients.
S# Excipients Role of excipients Reference Supplier Name / Address

Boai NKY Pharma Ltd,
(Pvp k30) BP 2014 China
Tablet binder
1 (Ph Eur monograph 0685)
at concentrations between 0.5% –5%
Polyvinyl pyrolidone potassium Vol 2, Page # II-638 Hangzhou Starshine
Pharmaceuticals Co Ltd, China
Tablet binder in wet granulation process
Corn starch at concentrations between 3% – 20% BP 2014
Rafhan Industrial Division,
Pakistan
(Maize starch) Tablet / capsule disintegrant Vol 2, Page # II-911
at concentrations between 3% – 25%
BP 2014
Used as a filler or diluent Foremost Farms Cooperativ,
3 Lactose monohydrate (Ph Eur monograph 0187)
in tablets / capsules USA
Vol 2, Page # II-65
Used as a filler or diluent Foremost Farms Cooperativ,

4 Lactose sd In-house
in tablets / capsules USA
(Avicel 102) BP 2014

Tablet binder in direct granulation JRS Pharma GMBH & CO.KG,
at concentrations between 10% –90% Germany
Microcrystalline cellulose Vol 1, Page # I-468
Used as a disintegrant
(Primojel) at concentrations between 1% - 8% BP 2014
Hangzhou Starshine
With the optimum concentration about 4%, Pharmaceuticals Co Ltd, China
Sodium starch glycolate Vol 2, Page # II-865
although in many cases 2% is sufficient.
Used as disintegrant in capsules
at concentrations between 10% – 25% BP 2014
Croscarmellose sodium Accent Microcell Private
Limited, India
Used as disintegrant in tablets Volume # 01, Page # I-643
at concentrations between 0.5% – 5%

As disintegrating agent: Kyron T-314 has a
very high swelling tendency of hydration
either in contact with water or G.I. fluids
causing fast disintegration without the
formation of lumps and thus acts as an
effective tablet super disintegrant.
Required quantity is from 0.5% to 4.0% to
Kyron T-314 get fast disintegration.
8 In-house Corel Pharma Chem, India
(Polacrilin potassium) As dissolution improver: Kyron T-314
breaks the tablets into very smaller
particles, thus it increases the effective
surface area for the absorption of the active
substances and thus it increases the
dissolution and bioavailability of the active
substances. Required quantity is from 2.0%
to 6.0% for dissolution improvement.
Used as an antiadherent
(Aerosil 200) BP 2014
Used as a glidant Wacker Chemie A.G.81737
at concentrations between 0.1% – 1% munchen, Germany
Colloidal silicon dioxide Vol 2, Page # II-804
Used as a suspending and thickening agent
BP 2014 Haicheng Success Resource
Used as an antiadherent
10 Talc (Ph Eur monograph 0438) Co., Ltd
at concentrations between 1% – 10 %
Vol 2, Page # II-968 Rurka Export, China
BP 2014
Used as a lubricant Coin Power International
11 Magnesium stearate (Ph Eur monograph 0229)
at concentrations between 0.25% – 2.0% Co., Ltd, Taiwan
Vol 2, Page # II-638
(SLS) BP 2014
Used as dissolution enhancer
12 (Ph Eur monograph 0098) Lahore Chemical, Pakistan
at concentrations between 1% – 2.0%
Sodium Lauryl Sulphate Volume # 02, Page # II-851
Prosolv SMCC 50
Tablet binder in direct granulation JRS Pharma GMBH & CO.KG,
13 In-house
(Silicified Microcrystalline at concentrations between 10% –90% Germany
Cellulose)
Pruv BP 2014
Used as a lubricant JRS Pharma GMBH & CO.KG,
at concentrations between 0.5% – 2.0% Germany
(Sodium stearyl fumarate) Vol # 2, Page # II-869
(HPMC E5)
BP 2014
Coating agent; film-former in coating The Dow Chemical Company
Hydroxy propyl at concentrations between 1% – 10 % Midland, USA
Vol 1, Page # I-1161
methyl cellulose E5
(Tio2) BP 2014
Used as an opacifier in coating
16 (Ph Eur monograph 1046) Kronos Titanox, Germany
at concentrations between 0.3% – 2 %
Titanium dioxide Vol 2, Page # II-1046
(PEG 6000) BP 2014

Used as a plasticizer in coating
17 (Ph Eur monograph 1444) Lotte Chemical, Korea
at concentrations between 0.3% – 2%
Polyethylene glycol 6000 Vol 2, Page # II-146
Organic solvent used as a wetting agent in BP 2014

YII= Diann Chemical Industry
18 Isopropyl alcohol wet granulation process (Ph Eur monograph 0970)
Co., Ltd., Taiwan
at concentrations between 12% – 80% Vol 1, I-1234
BP 2014
YII= Diann Chemical Industry
19 Isopropyl alcohol Organic solvent in tablet coating (Ph Eur monograph 0970)
Co., Ltd., Taiwan
Vol 1, I-1234
BP 2014
20 Purified water Aqueous solvent in tablet coating (Ph Eur monograph 0008) In-house
Vol 2, II-1168
Carboxymethylcellulose sodium Used as a suspending agent BP 2014

21 viscosity increasing agent (Ph Eur monograph 0472) Maido Corporation, Japan
(Carmellose sodium) at concentrations between 0.1% – 1% Vol 1, Page # I-412
Used as a stabilizing agent BP 2014

22 Xanthan gum suspending agent / thickening agent (Ph Eur monograph 1277) Deosen Biochemical Ltd., China
at concentrations between 0.2% – 1% Vol 2, Page # II-1184
BP 2014
Used as an antimicrobial preservative Jiangxi Vista Enterprise, Co.,
23 Sodium benzoate (Ph Eur monograph 0123)
at concentrations between 0.02% – 0.5% Ltd., China
BP 2014 Mengzhou Huaxing Biochemical

Used as a sweetener
24 Aspartame (Ph Eur monograph 0973) Co., Ltd., No. 96 Changiro Road
upto 15mg per kg body weight
Vol 1, Page # I-198 Menzhou Henan, China
BP 2014
Used as a sweetener Jiangxi Dongxu Chemical
25 Saccharin sodium (Ph Eur monograph 0787)
upto 5mg per kg body weight Technology Co., China
BP 2014
Used as a buffering agent Jiangxi Dongxu Chemical
26 Sodium citrate (Ph Eur monograph 0412)
at concentrations between 0.2% – 2% Technology Co., China
Used as an acidifying agent, buffering BP 2014

Jiangxi Dongxu Chemical
27 Citric acid agent and flavor enhancer (Ph Eur monograph 0455)
Technology Co., China
at concentrations between 0.1% - 2% Vol 1, Page # I-560
(Sugar)
BP 2014
Used as a bulk diluent
28 (Ph Eur monograph 0204) Alkhaleeg, UAE
Sucrose Sweetener
(Refined Sugar)
Dextrose BP 2014
29 (Glucose Monohydrate) Used as a bulk diluent (Ph Eur monograph 0178) Xiwang Pharma Co., Ltd., China
(Vol 1, Page # 1054)
TYFRANSCO
Used as a flavor Allied Axiom Chemical
30 Flavor In-house
at concentrations between 0.1% – 1% Private Limited, Karachi,
Pakistan
BP 2014
Used as a diluent ICD Biochemistry Co., Ltd.,
31 Sorbitol powder (Eur. monograph 0435)
at concentrations between 10% –90% China
Volume # 02, Page # II-886
BP 2014
Used as a diluent
32 Mannitol (Ph. Eur. monograph 0559) Singsino Group limited, China
at concentrations between 10% –90%
(BP 2014)
33 Methanol Organic solvent (Ph. Eur. monograph 1989) Sigma Aldrich, Germany
34 Hard Gelatin Capsule shell ------- In-house Gel Caps, Karachi

(Pvp k30)
Polyvinyl pyrolidone potassium
BP 2014
(Ph Eur monograph 0685)
S# Description Specifications
1 Appearance White Crystalline powder
2 Solubility soluble in water
3 Identification Conforms
4 PH 3.0 – 7.0
5 L.O.D NMT 5%
6 Bulk Density 0.290 - 0.390g/ml
7 Tapped Density 0.390 - 0.54g/ml

Isopropyl Alcohol
BP 2014
Vol 1, I-1234
1 Appearance Clear colourless Volatile liquid
2 Solubility Miscible with water
4 RI 1.376 – 1.379
5 Water NMT 0.5%
6 Specific Gravity 0.785 – 0.789

Corn Starch
BP 2014
Irregular, agular white masses of fine
1 Appearance
powder
Insoluble in cold water and in alcohol,
2 Solubility
soluble in boiling water
A: Prepare a smooth mixture of 1 g of it
with 2 mL of cold water, stir it into 15 mL
of boiling water, boil gently for 2 minutes,
3 Identification and cool: a translucent, whitish jelly is
produced.
B: Water slurry of it is colored reddish
violet to deep blue by iodine TS.
4 PH of 20% Suspension Between 4.0 and 7.0.
5 Loss on drying: NMT 15 %
6 Iron: NMT 0.001%.
7 Residue on ignition NMT0.6%
8 Oxidizing substances: NMT0.002%
9 Sulfur dioxide: NMT0.005%

The total aerobic microbial count does not
exceed 500 cfu per g and the total combined
10 Microbial limits
molds and yeasts count does not exceed 50
cfu per g.
Lactose monohydrate
BP 2014
Vol 2, Page # II-65
1 Appearance White powder
Freely but slowly soluble in water. Insoluble

2 Solubility
in ethanol (96%)
4 Water / LOD 4.5% - 5.5%
NMT 0.4ml of 0.1N NaOH is required to

5 Acidity /Alkalinity
change colour
6 Bulk Density NMT 0.540 g /cm3
7 Tapped Density NMT 0.800 g /cm3

Lactose SD
BP 2014
Vol 2, Page # II-66
1 Appearance White Crystalline powder
Freely but slowly soluble in water. Insoluble

2 Solubility
in ethanol (96%)
4 Water / LOD NMT 1%
NMT 0.4ml of 0.1N NaOH is required to

5 Acidity /Alkalinity
change colour
6 Bulk Density NMT 0.670 g / cm3
7 Tapped Density NMT 0.780 g / cm3

(Avicel 102)
Microcrystalline cellulose
BP 2014
Vol 1, Page # I-468
1 Appearance White crystalline powder
2 Solubility Insoluble in water
4 PH 5.0 – 7.5
5 LOD NMT 7%

(Primojel)
Sodium starch glycolate
BP 2014
1 Appearance White fine free flowing powder
2 Solubility Gives Translucent Suspension in Water
4 PH 5.5 – 7.5
5 LOD NMT 10%

Croscarmellose Sodium
BP 2014
Volume # 01, Page # I-643
1 Appearance White or grayish-white powder.

Practically insoluble in acetone, in
2 Solubility anhydrous ethanol and in toluene.
4 PH of 20% Suspension Between 4.0 and 7.0.
5 Loss on drying: NMT 10%
6 Water-soluble substances NMT 10.0 per cent.
7 Heavy metals Maximum 20 ppm.
8 Sulfated ash 14% to 28%

Settling volume
9 Meet the requirement
Degree of substitution
10 0.60 to 0.85 (dried substance).
Kyron T-314
(Polacrilin potassium)
(In-house)
A cream colored odorless and tasteless, free-

1 Appearance
flowing powder
2 Solubility Insoluble in water
Identification Kyron T-314

3
UV should be positive
4 Loss on drying Not more than 10%

(Aerosil 200)
Colloidal silicon dioxide
BP 2014
Alight ,fine, white or almost white

1 Appearance
amorphous powder
Insoluble in water and in mineral acids
2 Solubility
except hydrofluoric acid
3 Identification Reactions of silicates must positive
4 PH of 1gram in 30 ml water suspension 3.5 – 5.5
5 Loss on ignition NMT 5.0%
6 Chlorides NMT 250 ppm
7 Heavy metals NMT 25 ppm

Talc
BP 2014
2 Solubility Insoluble in Water
4 PH 7 – 10

Magnesium stearate
BP 2014
1 Appearance White powder ,greasy to touch
2 Solubility Insoluble in Water
4 Water/LOD NMT6%

(SLS)
Sodium Lauryl Sulphate
BP 2014
1 Appearance White or pale yellow, powder or crystals.
Freely soluble in water giving an opalescent

2 Solubility solution, partly soluble in ethanol
(96 percent).
4 Non-esterified alcohols NMT 4.0%
5 Alkalinity Meet the requirement

Prosolv SMCC 50
(Silicified Microcrystalline Cellulose)
(In-house)
White or almost white, fine or granular

1 Appearance
powder.
Dispersible in water producing a white,
opaque colloidal dispersion; practically
2 Solubility
insoluble in organic solvents and in dilute
acids.
4 Loss on Drying NMT 6.0%
5 PH 5.7-----------7.0
6 Bulk Density 0.250gm/ml ------------0.370gm/ml
7 Tapped Density 0.370gm/ml ------------0.550gm/ml

Pruv
(Sodium stearyl fumarate)
BP 2014
Vol # 2, Page # II-869
White or almost white, fine powder with

1 Appearance
agglomerates of flat, circular particles
Practically insoluble in water, slightly
2 Solubility soluble in methanol, practically insoluble in
acetone and in anhydrous ethanol.
3 Identification Conform
4 Water NMT 5.0%

(HPMC E5)
Hydroxy propyl methyl cellulose E5
BP 2014
2 Solubility Soluble in cold water
4 PH 5.5-8.0
5 Water/LOD NMT 5%
6 Bulk Density 0.40-0.440g/ml
7 Tapped Density 0.490-0.520g/ml

Titanium Dioxide
BP 2014
Insoluble in water and Slowly soluble in hot

2 Solubility
concentrated H2SO4
NMT 1 ml of 0.01N NaOH is required to

4 Acidity/Alkalinity
change the colour
(PEG 6000)
Polyethylene glycol 6000
BP 2014
1 Appearance White crystals or flakes
2 Solubility soluble in water
4 PH 4.5 – 7.5
5 Melting point 550 C - 630 C

Isopropyl Alcohol
BP 2014
Vol 1, I-1234
2 Solubility Miscible with water
4 RI 1.376 – 1.379
5 Water NMT 0.5%
6 Specific Gravity 0.785 – 0.789

Purified Water
BP 2014
Vol 2, II-1168
Clear, colourless, odourless and tasteless

1 Appearance
liquid
2 Nitrates Maximum 0.2 ppm
3 Aluminium Maximum 10 mg/l
Maximum 0.1 ppm.

4 Heavy metals
5 pH 5.0 – 7.5
6 Heavy Metals Maximum 0.002%.
7 Conductivity maximum 4.3 µScm-1 at 20C
8 total organic carbon NMT 0.5 mg/l
9 Oxidisable substances Must passes test

Carboxymethylcellulose sodium
(Carmellose Sodium)
BP 2014
Vol 1, Page # I-412
A white or almost white, granular powder,

1 Appearance
hygroscopic after drying
Practically insoluble in acetone, in ethanol
2 Solubility and in toluene. It is easily dispersed in water
giving colloidal solutions.
3 Appearance of solution Clear
4 pH 6.0 to 8.0.
5 Chlorides 5.0 – 7.5
6 Heavy Metals 20ppm
7 Sulfated ash 20.0 per cent to 33.3 per cent

Xanthan gum
BP 2014
1 Appearance White Or yellowish free flowing powder
soluble in water Practically Insoluble in

2 Solubility
organic solvent
Identification
3 Conforms
4 LOD NMT 15%
5 pH 6.0---8.0
Sodium benzoate
BP 2014
White or crystalline granular hygroscopic

1 Appearance
powder or flakes.
Freely soluble in water, sparingly soluble in
2 Solubility
alcohol
4 Sieve Analysis (60 mesh) NLT 60% should Passed

Aspartame
BP 2014
Vol 1, Page # I-198
1 Appearance A white, crystalline powder
Slightly soluble in water and in alcohol

2 Solubility practically insoluble in hexane and in
dichloromethane
3 Loss on Drying NMT 4.5 %
4 Sieve Analysis 60 mesh NLT 90% Should Passes
Bulk Density
5 0.200gm/ml--------0.260gm/ml
6 Tapped Density 0.300gm/ml--------0.35gm/ml
7 Assay 98% ------------102%

Saccharin sodium
BP 2014
1 Appearance White crystals
2 Solubility Soluble in water
4 LOD NMT 15%
5 PH 226°C---230°C
6 Assay 98---102%
Sodium citrate
BP 2014
White Crystalline or granular powder or

1 Appearance
flakes
Freely soluble in water Practically insoluble
2 Solubility
in ethanol
Identification
3 Test for Citrate
Conforms
Test for Sodium
4 LOD 11.0---13.0%
5 Assay 99%---101%
Citric Acid
BP 2014
Vol 1, Page # I-560
1 Appearance White to off-white Crystalline powder
2 Solubility Freely soluble in water
4 Water 7.5—9.0%
5 Melting Point 154°C
6 Assay 99.5---101.0%
Sucrose
(Refined Sugar)
BP 2014
1 Appearance White or almost white crystalline powder
Very soluble in water, slightly soluble in

2 Solubility ethanol(96%) practically insoluble in
anhydrous ethanol
4 Sieve Analysis (60 mesh) NLT 60% should Passed

Dextrose
(In-house)
1 Appearance White or almost white, crystalline powder,
Freely soluble in water, sparingly soluble in

2 Solubility
ethanol (96 per cent)
Water
3 NMT 1.0 %
NLT 90% Should Passes

4 Sieve Analysis 60 mesh
Specific optical rotation + 52.5º to + 53.3º.

5
Appearance of solution Solution should be clear

6
7 Bacterial endotoxins Less than 1.25 EU/g

Sorbitol
BP 2014
(Eur. monograph 0435)
1 Appearance White or almost white, crystalline powder
Very soluble in water, practically insoluble

2 Solubility
in ethanol (96 per cent)
4 Specific optical rotation + 4.0 to + 7.0
5 Water 1.5 %
7 Conductivity Maximum 20 µS·cm-1.
8 Reducing sugars NMT 0.2%
9 Lead NMT 0.5 ppm.
10 Nickel NMT 1ppm

Mannitol
BP 2014
(Ph. Eur. monograph 0559)
White or almost white, crystalline powder or
1 Appearance
free-flowing granules
Freely soluble in water, very slightly soluble
2 Solubility
4 Specific optical rotation + 23 to + 25
5 Melting point 165 °C to 170 °C.
6 Water NMT 0.5 %
8 Conductivity Maximum 20 µS·cm-1.
9 Reducing sugars NMT 0.2%
10 Lead NMT 0.5 ppm.
11 Nickel NMT 1ppm
12 Conductivity Maximum 20 µS·cm-1

Methanol
(BP 2014)
1 Appearance Clear, colorless, volatile, hygroscopic liquid
Miscible with water and with methylene

2 Solubility
chloride
Boiling Point
4 About 64 °C.
5 Appearance Clear
6 Relative density 0.791 to 0.793.
7 Residue on evaporation Maximum 10 ppm.
8 Water Maximum 0.10

Hard Gelatin Capsule shell

(In-house)
Hard gelatin capsule shell

1 Appearance
cap and body
2 Size
3 Solubility Soluble in water
5 Water/LOD 12 – 15 %
6 D. Time NMT 30 minutes

ANALYTICAL PROCEDURE OF
INACTIVE PHARMACEUTICAL
INGREDIENTS
METHOD OF ANALYSIS
(Pvp k30)
BP 2014
Objective:
To check and verify the qualitative and quantitative status of the incoming raw materials
Scope:
This procedure is applicable in Quality Control department.
Responsibility:
Quality Control Manager / Quality Control Analyst
Procedure:
Carry out the following analysis according to the individual S.A.P for the raw material samples
Content
11.5 per cent to 12.8 per cent of nitrogen (N; Ar 14.01) (anhydrous substance).
The different types of povidone are characterized by their viscosity in solution, expressed as a K-value.
Appearance:
White or yellowish-white powder or flakes, hygroscopic
Solubility:
Freely soluble in water, in ethanol (96 per cent) and in methanol, slightly soluble in acetone
TESTS
Identification
A. To 0.4 ml of solution S1 (see Tests) add 10 ml of water R, 5 ml of dilute hydrochloric acid R
and 2 ml of potassium dichromate solution R. An orange-yellow precipitate is formed.
B To 1 ml of solution S1 add 0.2 ml of dimethylaminobenzaldehyde solution R1 and 0.1 ml of

sulphuric acid R. A pink colour is produced.
C To 0.1 ml of solution S1 add 5 ml of water R and 0.2 ml of 0.05 M iodine. A red colour is
produced.
E. It is freely soluble in water R.
Solution S: Dissolve 1.0 g in carbon dioxide-free water Rand dilute to 20 ml with the same solvent.
Add the substance to be examined to the water in small portions with magnetic stirring.
Solution S1:
Dissolve 2.5 g in carbon dioxide-free water R and dilute to 25 ml with the same solvent. Add the
substance to be examined to the water in small portions with magnetic stirring.
Appearance of solution:
Solution S is clear and not more intensely colored than reference solution.
pH:
3.0 to 5.0 for solution S, for povidone having a stated K-value of at most 30; 4.0 to 7.0 for solution
S, for povidone having a stated K-value of more than 30
Viscosity, expressed as K-value:

For povidone having a stated value of 18 or less, use a 50 g/l solution. For povidone having a
declared value of more than 18, use a 10 g/l solution. For povidone having a declared value of more
than 95, use a 1.0 g/l solution.
Allow to stand for 1 h and determine the viscosity (2.2.9) of the solution at 25 °C, using viscometer
No.1 with a minimum flow time of 100 s. Calculate the K-value from the expression:
Concentration of the substance to be examined, calculated with reference to the anhydrous

substance, in grams per 100 ml,
 = viscosity of the solution relative to that of water R.
Isopropyl Alcohol
BP 2014
Vol 1, I-1234
Objective:
Scope:
Responsibility:
Procedure:
Appearance: Clear, colourless liquid
TESTS
Solubility: Miscible with water and with alcohol
Identification
A. Relative density: 0.785 to 0.789.
B. Refractive index: 1.376 to 1.379.
C. to 1 ml adds 2 ml of potassium dichromate solution R and 1 ml of dilute sulphuric acid R.
Boil. Vapour is produced which changes the colour of a piece of filter paper impregnated with
nitrobenzaldehyde solution R to green. Moisten the filter paper with dilute hydrochloric acid R.
The colour changes to blue.
Appearance: The substance to be examined is clear and colourless Dilute 1 ml to 20 ml with

water R. After 5 min, the solution is clear.
Absorbance: Maximum 0.30 at 230nm, 0.10 at 250nm, 0.03 at 270nm, 0.02 at 290nm & 0.01 at
310nm, the absorbance is measured between 230 nm and 310 nm using water R as the
compensation liquid. The absorption curve is smooth.
Non-volatile substances: Maximum 20ppm

Evaporate 100 g to dryness on a water-bath after having verified that it complies with the test for
peroxides and dry in an oven at 100-105 °C. The residue weighs a maximum of 2 mg.
Corn Starch
BP 2014
Objective:
Scope:
Responsibility:
Procedure:
Corn Starch consists of the granules separated from the mature grain of corn [Zea mays Linné (Fam.
Gramineae)].
Packaging and storage:

Preserve in well-closed containers.
Appearance:
Irregular, agular white masses of fine powder
Solubility:
Insoluble in cold water and in alcohol, soluble in boiling water
Botanic characteristics:
Polygonal, rounded or spheroidal granules up to about 35 µm in diameter and usually having a
circular or several-rayed central cleft
Identification:
A: Prepare a smooth mixture of 1 g of it with 2mL of cold water, stir it into 15mL of boiling water,
boil gently for 2 minutes, and cool: a translucent, whitish jelly is produced.
B: Water slurry of it is colored reddish violet to deep blue by iodine TS.
Microbial limits:
The total aerobic microbial count does not exceed 500 cfu per g and the total combined molds and
yeasts count does not exceed 50 cfu per g.
PH:
Prepare slurry by weighing 20.0 g ± 100 mg of Topical Starch, transferring to a suitable nonmetallic
container, and adding 100mL of water. Agitate continuously at a moderate rate for 5 minutes, then
stop agitation, and immediately determine the pH to the nearest 0.1 unit: the pH, determined
potentiometrically, is between 4.0 and 7.0.
Loss on drying:
Dry it at 130 for 90minutes: it loses not more than 15.0% of its weight.
Residue on ignition:
Not more than 0.6%, determined on a 2.0-g test specimen ignited at a temperature of 575 ± 25 .
Iron:
Dissolve the residue obtained in the test for Residue on ignition in 4mL of hydrochloric acid with the
aid of gentle heating, dilute with water to 50mL, and mix. Dilute 25mL of the resulting solution with
water to 47mL: the limit is 0.001%.
Oxidizing substances:
Transfer 4.0 g to a glass-stoppered, 125-mL conical flask, and add 50.0 mL of water. Insert the
stopper, and swirl for 5 minutes. Decant into a glass-stoppered, 50-mL centrifuge tube, and spin to
clarify. Transfer 30.0 mL of clear supernatant to a glass-stoppered, 125-mL conical flask.
Add 1mL of glacial acetic acid and 0.5 g to 1.0 g of potassium iodide. Insert the stopper, swirl, and
allow standing for 25 to 30 minutes in the dark. Add 1mL of starch TS, and titrate with 0.002 N
sodium thiosulfate VS to the disappearance of the starch-iodine color. Each mL of 0.002 N sodium
thiosulfate is equivalent to 34 µg of oxidant, calculated as hydrogen peroxide. Not more than 12.6mL
of 0.002N sodium thiosulfate is required (0.002%).
Sulfur dioxide:
Mix 20 g with 200 mL of water to obtain a smooth suspension, and filter. To 100 mL of the clear
filtrate add 3 mL of starch TS, and titrate with 0.01 N iodine VS to the first permanent blue color: not
more than 2.7 mL is consumed (0.005%).
Lactose monohydrate
BP 2014
Vol 2, Page # II-65
Objective:
Scope:
Responsibility:
Procedure:
Definition:
Lactose monohydrate is the monohydrate of O--D-galactopyranosyl-(14)--D-glucopyranose.
Characters:
A white or almost white, crystalline powder, freely but slowly soluble in water, practically insoluble
Identification
A. Dissolve 0.25 g in 5 ml of water R. Add 5 ml of ammonia R and heat in a water-bath at 80 °C for
10 min. A red colour develops.
B. It complies with the test for water (see Tests).
Absorbance:
Dissolve 1.0 g in boiling water R and dilute to 10.0 ml with the same solvent (solution A). The
absorbance of the solution measured at 400 nm is not greater than 0.04. Dilute 1.0 ml of solution A
to 10.0 ml with water R. Examine the solution from 210 nm to 300 nm. At wavelengths from 210 nm
to 220 nm, the absorbance is not greater than 0.25. At wavelengths from 270 nm to 300 nm, the
absorbance is not greater than 0.07.
Dissolve 1.0 g in boiling water R, dilute to 10 ml with the same solvent. The solution is clear and not
more intensely colored than reference solution.
Acidity or alkalinity:
Dissolve 6.0 g by heating in 25 ml of carbon dioxide-free water R, cool and add 0.3 ml of
phenolphthalein solution R. The solution is colourless. Not more than 0.4 ml of 0.1 M sodium
hydroxide is required to change the colour of the indicator to pink.
Heavy metals:
Dissolve 4.0 g in water R with warming, add 1 ml of 0.1 M hydrochloric acid and dilute to 20 ml
with water R. 12 ml of the solution complies with limit test A for heavy metals (5 ppm). Prepare the
reference solution using lead standard solution (1 ppm Pb) R.
Water:
4.5 per cent to 5.5 per cent determined on 0.50 g by the semi-micro determination of water, using a
mixture of 1 volume of formamide R and 2 volumes of methanol R as the solvent.
Sulphated ash:
Not more than 0.1 per cent. To 1.0 g add 1 ml of sulphuric acid R, evaporate to dryness on a water-
bath and ignite to constant mass.
Microbial contamination:
Total viable aerobic count not more than 102 micro-organisms per gram, determined by plate-count. It
complies with the test for Escherichia coli.
Lactose SD
BP 2014
Vol 2, Page # II-66
Objective:
Scope:
Responsibility:
Procedure:
Definition:
Lactose monohydrate is the monohydrate of O--D-galactopyranosyl-(14)--D-glucopyranose.
Characters:
A white or almost white, crystalline powder, freely but slowly soluble in water, practically insoluble
Identification
A. Dissolve 0.25 g in 5 ml of water R. Add 5 ml of ammonia R and heat in a water-bath at 80 °C for
10 min. A red colour develops.
B. It complies with the test for water (see Tests).
Absorbance:
Dissolve 1.0 g in boiling water R and dilute to 10.0 ml with the same solvent (solution A). The
absorbance of the solution measured at 400 nm is not greater than 0.04. Dilute 1.0 ml of solution A
to 10.0 ml with water R. Examine the solution from 210 nm to 300 nm. At wavelengths from 210 nm
to 220 nm, the absorbance is not greater than 0.25. At wavelengths from 270 nm to 300 nm, the
absorbance is not greater than 0.07.
Dissolve 1.0 g in boiling water R, dilute to 10 ml with the same solvent. The solution is clear and not
more intensely colored than reference solution.
Dissolve 6.0 g by heating in 25 ml of carbon dioxide-free water R, cool and add 0.3 ml of
phenolphthalein solution R. The solution is colourless. Not more than 0.4 ml of 0.1 M sodium
hydroxide is required to change the colour of the indicator to pink.
Heavy metals:
Dissolve 4.0 g in water R with warming, add 1 ml of 0.1 M hydrochloric acid and dilute to 20 ml
with water R. 12 ml of the solution complies with limit test A for heavy metals (5 ppm). Prepare the
reference solution using lead standard solution (1 ppm Pb) R.
Water:
4.5 per cent to 5.5 per cent determined on 0.50 g by the semi-micro determination of water, using a
mixture of 1 volume of formamide R and 2 volumes of methanol R as the solvent.
Sulphated ash:
Not more than 0.1 per cent. To 1.0 g add 1 ml of sulphuric acid R, evaporate to dryness on a water-
bath and ignite to constant mass.
Total viable aerobic count not more than 102 micro-organisms per gram, determined by plate-count. It
complies with the test for Escherichia coli.
(Avicel 102)
BP 2014
Vol 1, Page # I-468
Objective:
Scope:
Responsibility:
Procedure:
Action and Use: Pharmaceutical aid.
Microcrystalline cellulose (Avicel) is purified, partly depolymerised cellulose
Definition: prepared by treating alpha cellulose, obtained as a pulp from fibrous plant
material, with mineral acids.
Description: A white or almost white, fine or granular powder, odorless and tasteless.
Practically insoluble in water, in acetone, in ethanol, in Toluene and in dilute
acids and in a 50-gm/liter solution of sodium hydroxide.
Solubility:
Dissolve 50 mg in 10 ml of ammoniacal solution of copper tetramine. It
dissolves completely, leaving no residue.
A) Place about 10 mg on a watch glass and disperse in 2 ml of iodinated zinc
Identification:
chloride solution. The substance becomes violet-blue.
Shake 5 gm with 40 ml of carbon dioxide free water for 20 minutes and
PH:
centrifuge. The pH of the supernatant liquid is 5.0 to 7.5.
Not more than 6.0 percent, determined on 1.0 gm by drying in an oven at 100 C
Loss on drying:
to 105 C for 3 hours.
To 10 gm add 90 ml of water and boil for 5 minutes. Filter whilst hot. Cool and
Starch:
add to the filtrate 0.1 ml of 0.05 M iodine. No blue colour is produced.
Shake 5.0 gm with 80 ml of water for 10 minutes. Filter with the aid of vacuum
Water-soluble
into a tarred flask. Evaporate to dryness on a water bath and dry at 100 0 C to
Substances:
1050 C for 1 hour. The residue weighs not more than 12.5 mg (0.25 Percent)
Residue on Ignition:
Not more than 0.05 percent.
(Primojel)
BP 2014
Objective:
Scope:
Responsibility:
Procedure:
Content:
2.8 per cent to 4.2 per cent of Na (substance washed with ethanol (80 per cent V/V) and dried).
Appearance:
White or almost white, fine, free-flowing powder, very hygroscopic
Solubility:
Practically insoluble in Methylene chloride
It gives a translucent suspension in water.
TESTS
Identification
A. pH (see Tests)
B. Prepare with shaking and without heating a mixture of 4.0 g of the substance to be examined and
20 ml of carbon dioxide-free water R. The mixture has the appearance of a gel. Add 100 ml of
carbon dioxide-free water R and shake. A suspension forms that settles after standing.
C. To an acidified solution, add iodinated potassium iodide solution R1. The solution becomes blue
or violet.
D. Solution S2 (see Tests) gives reaction (a) of sodium
PH: 5.5 to 7.5.

Disperse 1.0 g in 30 ml of water R.
Sodium chloride: Maximum 7.0 per cent.

Place 0.500 g in a beaker and suspend in 100 ml of water R. Add 1 ml of nitric acid R.
Titrate with 0.1 M silver nitrate, determining the end-point potentiometrically using a silver
indicator electrode.
1 ml of 0.1 M silver nitrate is equivalent to 5.844 mg of NaCl.
Loss on drying:
Maximum 10.0 per cent, determined on 1.000 g by drying in an oven at 130 °C for 1.5 h.
It complies with the test for Escherichia coli and Salmonella.
ASSAY:
Shake 1.000 g with 20 ml of ethanol (80 per cent V/V) R, stir for 10 min and filter. Repeat the
operation until chloride has been completely extracted and verify the absence of chloride using
silver nitrate solution R2. Dry the residue at 105 °C to constant mass. To 0.700 g of the dried
residue, add 80 ml of glacial acetic acid R and heat under a reflux condenser for 2 h. cool the
solution to room temperature. Titrate with 0.1 M perchloric acid, determining the end-point
potentiometrically .Carry out a blank titration.
1 ml of 0.1 M perchloric acid is equivalent to 2.299 mg of Na.

Croscarmellose Sodium
(BP 2014)
Objective:
Scope:
Responsibility:
Procedure:
DEFINITION
Cross-linked sodium carboxymethylcellulose
Sodium salt of a cross-linked, partly O-carboxymethylated cellulose
CHARACTERS
Appearance
White or greyish-white powder
Solubility
Practically insoluble in acetone, in anhydrous ethanol and in toluene
IDENTIFICATION
A. Mix 1 g with 100 mL of a solution containing 4 ppm of methylene blue R, stir the mixture and
allow it to settle. The substance to be examined absorbs the methylene blue and settles as a blue,
fibrous mass.
B. Mix 1 g with 50 mL of water R. Transfer 1 mL of the mixture to a small test-tube and add 1 mL of
water R and 0.05 mL of a freshly prepared 40 g/L solution of -naphthol R in methanol R. Incline
the test-tube and carefully add 2 mL of sulfuric acid R down the side so that it forms a lower layer. A
reddish-violet colour develops at the interface.
C. The solution prepared from the sulfated ash in the test for heavy metals (see Tests) gives reaction
(a) of sodium (2.3.1).
TESTS
pH (2.2.3)
5.0 to 7.0 for the suspension.
Shake 1 g with 100 mL of carbon dioxide-free water R for 5 min.
Sodium chloride and sodium glycollate

Maximum 0.5 per cent (dried substance) for the sum of the percentage contents of sodium chloride
and sodium glycollate.
Sodium chloride: Place 5.00 g in a 250 mL conical flask, add 50 mL of water R and 5 mL of strong
hydrogen peroxide solution R and heat on a water-bath for 20 min, stirring occasionally to ensure
total hydration. Cool, add 100 mL of water R and 10 mL of nitric acid R. Titrate with 0.05 M silver
nitrate, determining the end-point potentiometrically (2.2.20) using a silver indicator electrode and a
double-junction reference electrode containing a 100 g/L solution of potassium nitrate R in the outer
jacket and a standard filling solution in the inner jacket, and stirring constantly. 1 mL of 0.05 M
silver nitrate is equivalent to 2.922 mg of NaCl.
Sodium glycollate: Place a quantity of the substance to be examined equivalent to 0.500 g of the
dried substance in a 100 mL beaker. Add 5 mL of glacial acetic acid R and 5 mL of water R and stir
to ensure total hydration (about 15 min). Add 50 mL of acetone R and 1 g of sodium chloride R. Stir
for several minutes to ensure complete precipitation of the carboxymethylcellulose. Filter through a
fast filter paper impregnated with acetone R into a volumetric flask, rinse the beaker and the filter
with 30 mL of acetone R and dilute the filtrate to 100.0 mL with the same solvent. Allow to stand for
24 h without shaking. Use the clear supernatant to prepare the test solution.
Prepare the reference solutions as follows: in a 100 mL volumetric flask, dissolve 0.100 g of
glycollic acid R, previously dried in vacuo over diphosphorus pentoxide R at room temperature
overnight, in water R and dilute to 100.0 mL with the same solvent; use the solution within 30 days;
transfer 1.0 mL, 2.0 mL, 3.0 mL and 4.0 mL of the solution to separate volumetric flasks, dilute the
contents of each flask to 5.0 mL with water R, add 5 mL of glacial acetic acid R, dilute to 100.0 mL
with acetone R and mix.
Transfer 2.0 mL of the test solution and 2.0 mL of each of the reference solutions to separate 25 mL
volumetric flasks. Heat the uncovered flasks for 20 min on a water- bath to eliminate acetone. Allow
to cool and add 5.0 mL of 2,7-dihydroxynaphthalene solution R to each flask. Mix, add a further
15.0 mL of 2,7-dihydroxynaphthalene solution R and mix again. Close the flasks with aluminium
foil and heat on a water- bath for 20 min. Cool and dilute to 25.0 mL with sulfuric acid R.
Measure the absorbance (2.2.25) of each solution at 540 nm. Prepare a blank using 2.0 mL of a
solution containing 5 per cent V/V each of glacial acetic acid R and water R in acetone R. Prepare a
standard curve using the absorbances obtained with the reference solutions. From the standard curve
and the absorbance of the test solution, determine the mass (a) of glycollic acid in the substance to be
examined, in milligrams, and calculate the content of sodium glycollate using the following
expression:
1.29 = the factor converting glycollic acid to sodium glycollate;

b=loss on drying as a percentage;
m = mass of the substance to be examined, in grams.
Water-soluble substances
Maximum 10.0 per cent
Disperse 10.00 g in 800.0 mL of water R and stir for 1 min every 10 min during the first 30 min.
Allow to stand for 1 h and centrifuge if necessary. Decant 200.0 mL of the supernatant liquid onto a
fast filter paper in a vacuum filtration funnel, apply vacuum and collect 150.0 mL of the filtrate.
Evaporate to dryness and dry the residue at 100-105 °C for 4 h.
Heavy metals (2.4.8): Maximum 20 ppm
To the residue obtained in the determination of the sulfated ash add 1 mL of hydrochloric acid R and
evaporate on a water-bath. Take up the residue in 20 mL of water R. 12 mL of the solution complies
with test A. Prepare the reference solution using lead standard solution (1 ppm Pb) R.
Loss on drying (2.2.32): Maximum 10.0 per cent, determined on 1.000 g by drying in an oven at 105
°C for 6 h.
Sulfated ash (2.4.14): 14.0 per cent to 28.0 per cent (dried substance), determined on 1.0 g, using a
mixture of equal volumes of sulfuric acid R and water R.
Settling volume: Place 75 mL of water R in a 100 mL graduated cylinder and add 1.5 g of the
substance to be examined in 0.5 g portions, shaking vigorously after each addition
Dilute to 100.0 mL with water R and shake again until the substance is homogeneously distributed.
Allow to stand for 4 h. The settling volume is between 10.0 mL and 30.0 mL.
Degree of substitution: 0.60 to 0.85 (dried substance).
Place 1.000 g in a 500 mL conical flask, add 300 mL of a 100 g/L solution of sodium chloride R and
25.0 mL of 0.1 M sodium hydroxide, stopper the flask and allow standing for 5 min, shaking
occasionally. Add 0.05 mL of m-cresol purple solution R and about 15 mL of 0.1 M hydrochloric
acid from a burette. Insert the stopper and shake. If the solution is violet, add 0.1 M hydrochloric acid
in 1 mL portions until the solution becomes yellow, shaking after each addition. Titrate with 0.1M
sodium hydroxide until the colour turns to violet.
Calculate the number of mill equivalents (M) of base required to neutralise the equivalent of 1 g of
dried substance.
Calculate the degree of acid carboxymethyl substitution (A) using the following expression:
C = sulfated ash as a percentage.

Calculate the degree of sodium carboxymethyl substitution (S) using the following expression:
The degree of substitution is the sum of A and S.
Kyron T-314
(In-house)
Objective:
Scope:
Responsibility:
Procedure:
Characteristic:
A cream colored odorless and tasteless, free-flowing powder
Identification:
Should be positive
Solubility:
Insoluble in water
Loss on drying:
Dry one gram of the sample at 105˚C for 6 hours (Not more than 10 %)
(Aerosil 200)
BP 2014
Objective:
Scope:
Responsibility:
Procedure:
Appearance:
Light, loose, Bluish white color, odorless, tasteless, nongritty, amorphous powder
Solubility:
Practically insoluble in organic solvents, water and acids
Soluble in hot solutions of alkali hydroxide
Form a colloidal dispersion with water.
PH:
3.5 – 5.5 (A 4.0% Dispersion with water)
Loss on drying:
NMT 2.5 % at 105 C
Loss on ignition:
NMT: 5.0%
Purified Talc
BP 2014

Objective:
Scope:
Responsibility:
Procedure:
Definition:
Talc is a powdered, selected, natural, hydrated magnesium silicate. Pure talc has the formula
[Mg3Si4O10 (OH)2; Mr379.3]. It may contain variable amounts of associated magnesium silicates),
magnesite (magnesium carbonate), calcite (calcium carbonate) and dolomite (calcium and
magnesium carbonate) are predominant.

Production:
Talc derived from deposits that are known to contain associated asbestos is not suitable for
pharmaceutical use. The manufacturer is responsible for demonstrating by the test for amphiboles and
serpentines that the product is free from asbestos. The presence of amphiboles and of serpentines is
revealed by X-ray diffraction or by infrared spectrophotometry (see A and B). If detected, the specific
morphological criteria of asbestos are investigated by a suitable method of optical microscopy to
determine whether tremolite asbestos or chrysotile is present, as described below.

A. Examine by infrared spectrophotometry (2.2.24). In the range 740 cm -1 to 760 cm-1 using scale
expansion, any absorption band at 758 cm-1 1 cm-1 may indicate the presence of tremolite or of
chlorite. If the absorption band remains after ignition of the substance at 850C for at least 30 min, it
indicates the presence of the tremolite. In the range 600 cm -1 to 650 cm-1 using scale expansion, any
absorption band or shoulder may indicate the presence of serpentines. Examine the substance
prepared as discs using potassium bromide R.
B. Examine by X-ray diffraction employing the following conditions:

Cu Ka monochromatic 40 kV radiation, 24 mA to 30 mA,
incident slit: 1C,
detection slit: 0.2C,
goniometer speed: 1/10C 2q/min,
Scanning range: 10C to 13C 2q and 24C to 26C 2q,
the sample is not oriented.
Place the sample on the sample holder; pack and smooth its surface with a polished glass microscope
slide.

Record the diffractograms.

The presence of amphiboles is detected by a diffraction peak at 10.5C 0.1C 2q, the presence of
serpentines is detected by diffraction peaks at 24.3C 0.1C 2q and at 12.1C 0.1C 2q.

If, by one of the 2 methods, amphiboles and/or serpentine are detected, examine by a suitable method
of optical microscopy to determine the asbestos character.
Examined by optical microscopy, the presence of asbestos is shown if the following criteria are met:
a range of length to width ratios of 20:1 to 100:1, or higher for fibres longer than 5 mm,
capability of splitting into very thin fibrils,
and if 2 or more of the following 4 criteria are met:
parallel fibres occurring in bundles,
fibre bundles displaying frayed ends,
fibres in the form of thin needles,
matted masses of individual fibres and/or fibres showing curvature.
Characters:
A light, homogeneous, white or almost white powder, greasy to the touch (non abrasive), practically
insoluble in water, in alcohol and in dilute solutions of acids and alkali hydroxides

Identification:
First identification
A.
Second identification
B, C.
A. Examine by infrared absorption spectrophotometry (2.2.24). The spectrum shows absorption

bands at 3677 cm-1 2 cm-1, at 1018 cm-1 2 cm-1 and at 669 cm-1 2 cm-1. Examine the substance as discs
prepared using potassium bromide R.
B. In a platinum crucible, melt a mixture of 0.2 g of anhydrous sodium carbonate R and 2.0 g of
potassium carbonate R. To the melted mass add 0.1 g of the substance to be examined and heat until
the mixture is completely melted. Allow to cool and transfer the melted mass into an evaporating dish
with 50 ml of hot water R. Add hydrochloric acid R until effervescence ceases. Add 10 ml of
hydrochloric acid R and evaporate to dryness on a water-bath. Allow to cool. Add 20 ml of water R,
heat to boiling and filter. (The residue is used for identification test C). To 5 ml of the filtrate add 1
ml of ammonia R and 1 ml of ammonium chloride solution R and filter. To the filtrate add 1 ml of
disodium hydrogen phosphate solution R. A white, crystalline precipitate is formed.
C. The residue obtained in identification test B gives the reaction of silicates (2.3.1).

Tests
Solution S 1:
Weigh 10.0 g of the substance to be examined into a conical flask fitted with a reflux condenser, add
50 ml of 0.5M hydrochloric acid gradually while stirring and heat on a water-bath for 30 min. allow
cooling. Transfer the mixture to a beaker and allow the undissolved material to settle.
Filter the supernatant through medium-speed filter paper into a 100 ml volumetric flask, retaining as
much as possible of the insoluble material in the beaker. Wash the residue and the beaker with 3
quantities, each of 10 ml, of hot water
R. Wash the filter with 15 ml of hot water R, allow the filtrate to cool and dilute to 100.0 ml with the
same solvent.
Solution S 2:
Weigh 0.5 g of the substance to be examined in a 100 ml polytetrafluoroethylene dish, add 5 ml of
hydrochloric acid R, 5 ml of lead-free nitric acid R and 5 ml of perchloric acid R. Stir gently then add
35 ml of hydrofluoric acid R and evaporate slowly to dryness on a hot plate
To the residue, add 5 ml of hydrochloric acid R, cover with a watch-glass, heat to boiling and allow
cooling. Rinse the watch-glass and the dish with water R. Transfer into a volumetric flask, rinse the
dish with water R and dilute to 50.0 ml with the same solvent.

pH (2.2.3)
The pH of the filtrate obtained in the test for water-soluble substances is 7.0 to 9.0. Read the pH 1
min after inserting the electrode.

Water-soluble substances
To 10.0 g add 50 ml of carbon dioxide-free water R, heat to boiling and maintain boiling under a
reflux condenser for 30 min. Allow to cool, filter through a medium-speed filter paper and dilute to
50.0 ml with carbon dioxide-free water R. Take 25.0 ml of the filtrate, evaporate to dryness and heat
at 105C for 1 h. The residue weighs not more than 10 mg (0.2 per cent).

Aluminium
Not more than 2.0 per cent of Al, determined by atomic absorption spectrometry (2.2.23, Method I).

Test solution
To 5.0 ml of solution S2 add 10 ml of a 25.34 g/l solution of caesium chloride R, 10.0 ml of
hydrochloric acid R and dilute to 100.0 ml with water R.

Reference solutions
Into 4 identical volumetric flasks, each containing 10.0 ml of hydrochloric acid R and 10 ml of a
25.34 g/l solution of caesium chloride R, introduce respectively 5.0 ml, 10.0 ml, 15.0 ml and 20.0 ml
of aluminium standard solution (100 ppm Al) R and dilute to 100.0 ml with water R. Measure the
absorbance at 309.3 nm, using an aluminium hollow-cathode lamp as the radiation source and a
nitrous oxide-acetylene flame.

Calcium
Not more than 0.9 per cent of Ca, determined by atomic absorption spectrometry (2.2.23, Method I).

Test solution
To 5.0 ml of solution S2 add 10.0 ml of hydrochloric acid R, 10 ml of lanthanum chloride solution R

and dilute to 100.0 ml with water R.
Reference solutions
Into 4 identical volumetric flasks, each containing 10.0 ml of hydrochloric acid R and 10 ml of
lanthanum chloride solution R, introduce respectively 1.0 ml, 2.0 ml, 3.0 ml and 4.0 ml of calcium
standard solution (100 ppm Ca) R1 and dilute to 100.0 ml with water R.
Measure the absorbance at 422.7 nm using a calcium hollow-cathode lamp as the radiation source
and a nitrous oxide-acetylene flame.

Iron
Not more than 0.25 per cent of Fe, determined by atomic absorption spectrometry (2.2.23, Method I).

Test solution
To 2.5 ml of solution S1, add 50.0 ml of 0.5M hydrochloric acid and dilute to 100.0 ml with water R.

Reference solutions
Into 4 identical volumetric flasks, each containing 50.0 ml of 0.5M hydrochloric acid, introduce
respectively 2.0 ml, 2.5 ml, 3.0 ml and 4.0 ml of iron standard solution (250 ppm Fe) R and dilute to
100.0 ml with water R.
Measure the absorbance at 248.3 nm using an iron hollow-cathode lamp as the radiation source and
an air-acetylene flame. Make a correction using a deuterium lamp.

Lead
Not more than 10 ppm of Pb, determined by atomic absorption spectrometry (2.2.23, Method I).

Test solution
Use solution S1.

Reference solutions
Into 4 identical volumetric flasks, each containing 50.0 ml of 0.5M hydrochloric acid, introduce
respectively 5.0 ml, 7.5 ml, 10.0 ml and 12.5 ml of lead standard solution (10 ppm Pb) R1 and dilute
to 100.0 ml with water R. Measure the absorbance at 217.0 nm using a lead hollow-cathode lamp as
the radiation source and an air-acetylene flame.
Magnesium
17.0 per cent to 19.5 % of Mg, determined by atomic absorption spectrometry (2.2.23, Method I).

Test solution
Dilute 0.5 ml of solution S2 to 100.0 ml with water R. To 4.0 ml of the solution, add 10.0 ml of
hydrochloric acid R, 10 ml of lanthanum chloride solution R and dilute to 100.0 ml with water R.

Reference solutions
Into 4 identical volumetric flasks, each containing 10.0 ml of hydrochloric acid R and 10 ml of
lanthanum chloride solution R, introduce respectively 2.5 ml, 3.0 ml, 4.0 ml and 5.0 ml of
magnesium standard solution (10 ppm Mg) R1 and dilute to 100.0 ml with water R. Measure the
absorbance at 285.2 nm using a magnesium hollow-cathode lamp as the radiation source and an air-
acetylene flame.

Loss on ignition
Not more than 7.0 per cent, determined on 1.00 g by ignition to constant weight at 1050-1100C.

Magnesium stearate
BP 2014
Objective:
Scope:
Responsibility:
Procedure:
Definition:
Magnesium stearate is a mixture of magnesium salts of different fatty acids consisting mainly of
stearic acid [(C17H35COO)2Mg; Mr 591.3] and palmitic acid [(C15H31COO)2 Mg; Mr 535.1] with
minor proportions of other fatty acids. It contains not less than 4.0 per cent and not more than 5.0
per cent of Mg (Ar 24.30), calculated with reference to the dried substance. The fatty acid fraction
contains not less than 40.0 per cent of stearic acid and the sum of stearic acid and palmitic acid is
not less than 90.0 per cent.
Characters:
A white, very fine, light powder, greasy to the touch, practically insoluble in water and in ethanol
TESTS
Identification
Solution S:
To 5.0 g add 50 ml of peroxide-free ether R, 20 ml of dilute nitric acid R and 20 ml of distilled
water R and heat under a reflux condenser until dissolution is complete. Allow to cool. In a
separating funnel, separate the aqueous layer and shake the ether layer with 2 quantities, each of
4 ml, of distilled water R. Combine the aqueous layers, wash with 15 ml of peroxide-free ether R
and dilute to 50 ml with distilled water R (solution S). Evaporate the organic layer to dryness and
dry the residue at 100-105 °C.
A. The residue obtained in the preparation of solution S (see Tests) has a freezing point not
lowers than 53 °C. .
B 1 ml of solution S gives the reaction of magnesium.
To 1.0 g add 20 ml of carbon dioxide-free water R and boil for 1 min with continuous stirring.
Cool and filter. To 10 ml of the filtrate add 0.05 ml of bromothymol blue solution R1. Not more
than 0.5 ml of 0.01 M hydrochloric acid or 0.01 M sodium hydroxide is required to change the
colour of the indicator.
Chlorides:
0.5 ml of solution S diluted to 15 ml with water R complies with the limit test for chlorides (0.1
per cent).
Sulphates:
0.3 ml of solution S diluted to 15 ml with distilled water R complies with the limit test for
sulphates (0.5 per cent).
Measure the absorbance at 232.0 nm, using a nickel hollow-cathode lamp as a source of radiation
and a graphite furnace as atomic generator.
Loss on drying:
Not more than 6.0 per cent, determined on 1.000 g by drying in an oven at 100-105 °C.
Total viable aerobic count not more than 103 micro-organisms per gram, determined by plate
count. It complies with the test for Escherichia coli.
ASSAY:
Magnesium
To 0.500 g in a 250 ml conical flask add 50 ml of a mixture of equal volumes of butanol R and
ethanol R, 5 ml of concentrated ammonia R, 3 ml of ammonium chloride buffer solution pH 10.0
R, 30.0 ml of 0.1 M sodium edetate and 15 mg of mordant black 11 triturate R. Heat to 45-50 °C
until the solution is clear and titrate with 0.1 M zinc sulphate until the colour changes from blue
to violet. Carry out a blank titration.
1 ml of 0.1 M sodium edetate is equivalent to 2.431 mg of Mg.

(SLS)
BP 2014
Objective:
Scope:
Responsibility:
Procedure:
DEFINITION
Mixture of sodium alkyl sulfates consisting chiefly of sodium dodecyl sulfate (C12H25NaO4S; Mr
288.4)
Content:
Sodium alkyl sulfates: minimum 85.0 per cent, expressed as C12H25NaO4S.
CHARACTERS
Appearance:
White or pale yellow, powder or crystals
Solubility:
Freely soluble in water giving an opalescent solution, partly soluble in ethanol (96 per cent)
IDENTIFICATION
A. Dissolve 0.1 g in 10 mL of water R and shake. Copious foam is formed.

B. To 0.1 mL of the solution prepared for identification test A, add 0.1 mL of a 1 g/L solution of
methylene blue R and 2 mL of dilute sulfuric acid R. Add 2 mL of methylene chloride R and shake.
An intense blue colour develops in the methylene chloride layer.
C. Mix about 10 mg with 10 mL of anhydrous ethanol R. Heat to boiling on a water-bath, shaking
frequently. Filter immediately and evaporate the ethanol. Dissolve the residue in 8 mL of water R,
add 3 mL of dilute hydrochloric acid R, evaporate the solution to half its volume and allow to cool.
Separate the congealed fatty alcohols by filtration. To the filtrate add 1 mL of barium chloride
solution R1. A white, crystalline precipitate is formed.
D. Ignite 0.5 g. The residue gives reaction (a) of sodium (2.3.1).
TESTS
Alkalinity:
Dissolve 1.0 g in 100 mL of carbon dioxide-free water R and add 0.1 mL of phenol red solution R.
Not more than 0.5 mL of 0.1 M hydrochloric acid is required to change the colour of the indicator.
Non-esterified alcohols:
Maximum 4 per cent
Dissolve 10 g in 100 mL of water R, add 100 mL of ethanol (96 per cent) R and shake the solution
with 3 quantities, each of 50 mL, of pentane R, adding sodium chloride R, if necessary, to promote
separation of the 2 layers. Wash the combined organic layers with 3 quantities, each of 50 mL, of
water R, dry over anhydrous sodium sulfate R, filter and evaporate on a water-bath until the solvent
has evaporated. Heat the residue at 105 °C for 15 min and cool. The residue weighs a maximum of
0.4 g.
Sodium chloride and sodium sulfate

Maximum 8.0 per cent for the total percentage content
Sodium chloride
Dissolve 5.00 g in 50 mL of water R, add dilute nitric acid R dropwise until the solution is neutral to
blue litmus paper R, add 2 mL of potassium chromate solution R and titrate with 0.1 M silver nitrate.
1 mL of 0.1 M silver nitrate is equivalent to 5.844 mg of NaCl.
Sodium sulfate
Dissolve 0.500 g in 20 mL of water R, warming gently if necessary, then add 1 mL of a 0.5 g/L
solution of dithizone R1 in acetone R. If the solution is red, add 1M nitric acid , dropwise, until the
solution becomes bluish-green. Add 2.0 mL of dichloroacetic acid solution R and 80 mL of acetone
R. Titrate with 0.01 M lead nitrate until a persistent violet-red or orange-red colour is obtained. Carry
out a blank titration.
1 mL of 0.01 M lead nitrate is equivalent to 1.420 mg of Na2SO4.
ASSAY
Dissolve 1.15 g in water R, warming if necessary, and dilute to 1000.0 mL with the same solvent. To
20.0 mL of the solution add 15 mL of chloroform R and 10 mL of dimidium bromide-sulfan blue
mixed solution R. Titrate with 0.004 M benzethonium chloride, shaking vigorously and allowing the
layers to separate before each addition, until the pink colour of the chloroform layer is completely
discharged and a greyish- blue colour is obtained.
1 mL of 0.004 M benzethonium chloride is equivalent to 1.154 mg of sodium alkyl sulfates,

expressed as C12H25NaO4S.
Prosolv SMCC 50
(In-house)
Objective:
Scope:
Responsibility:
Procedure:
CHARACTERS
Appearance
White or almost white, fine or granular powder
Solubility
Dispersible in water producing a white, opaque colloidal dispersion; practically insoluble in organic
solvents and in dilute acids
IDENTIFICATION
1-Infrared absorption spectrophotometry (2.2.24)
2-Place about 10 mg on a watch-glass and disperse in 2 mL of iodinated zinc chloride solution R. The
substance becomes violet-blue.
Loss on Drying:
Maximum 6.0 per cent, determined on 1.0 g
pH:
5.7 to 7.0
Shake 5 g with 40 mL of carbon dioxide-free water R for 20 min and centrifuge.
Bulk Density:
0.25g/ml to 0.370g/ml
Tapped Density:
0.370g/ml to 0.5g/ml
Pruv
BP 2014
Objective:
Scope:
Responsibility:
Procedure:
DEFINITION
Sodium octadecyl (E)-butenedioate
Content
99.0 per cent to 101.5 per cent (anhydrous substance).
CHARACTERS
Appearance: White or almost white, fine powder with agglomerates of flat, circular particles
Solubility: Practically insoluble in water, slightly soluble in methanol, practically insoluble in

acetone and in anhydrous ethanol
IDENTIFICATION
Infrared absorption spectrophotometry (2.2.24)
Comparison sodium stearyl fumarate CRS
Water (2.5.12): Maximum 5.0 per cent, determined on 0.250 g
Assay: Dissolve 0.250 g, accurately weighed, in 10 mL of methylene chloride R and add 30 mL of

anhydrous acetic acid R. Titrate with 0.1 M perchloric acid, determining the end-point
potentiometrically (2.2.20). 1 mL of 0.1 M perchloric acid is equivalent to 39.05 mg of C22H39NaO4.
(HPMC E5)
BP 2014
Objective:
Scope:
Responsibility:
Procedure:
TESTS
Description:
A white, yellowish-white or grayish-white powder or granules, hygroscopic after drying
Solubility:
Practically insoluble in hot water, in acetone, in ethanol, in ether and in toluene
It dissolves in cold water giving a colloidal solution.
Identification:
1. Heat 10 ml of solution S in a water-bath while stirring. At a temperature above 50°C the solution
becomes cloudy or a flocculent precipitate is formed. The solution becomes clear again on cooling.
2. Place 1 ml of solution S on a glass plate. After evaporation of the water a thin film is formed.
3. 0.2 g does not dissolve in 10 ml of toluene R nor in 10 ml of ethanol (96%).
pH: While stirring, introduce a quantity of the substance to be examined equivalent to 1.0 g of the
dried substance into 50 g of carbon dioxide-free water heated to 90°C. Allow to cool, adjust the mass
of the solution to 100 g with carbon dioxide-free water and stir until dissolution is complete. The pH
of the solution is 5.5 to 8.0.
Loss on drying: Not more than 10.0 per cent, determined on 1.000 g by drying in an oven at 100°C
to 105°C
Titanium Dioxide
BP 2014
Objective:
Scope:
Responsibility:
Procedure:
Characters:
A white or almost white powder, practically insoluble in water
It does not dissolve in dilute mineral acids but dissolves slowly in hot concentrated sulphuric
acid.
TESTS
Identification:
A. When strongly heated, it becomes pale yellow; the colour disappears on cooling.
B. To 5 ml of solution S2 (see Tests) add 0.1 ml of strong hydrogen peroxide solution R. An

orange-red colour appears.
C. To 5 ml of solution S2 add 0.5 g of zinc R in granules. After 45 min, the mixture has a violet-
blue colour.
Solution S1:
Shake 20.0 g with 30 ml of hydrochloric acid R for 1 min. Add 100 ml of distilled water R and
heat the mixture to boiling. Filter the hot mixture through a hardened filter paper until a clear
filtrate is obtained. Wash the filter with 60 ml of distilled water R and dilute the combined filtrate
and washings to 200 ml with distilled water R.
Solution S2:
Mix 0.500 g (m g) with 5 g of anhydrous sodium sulphate R in a 300 ml long-necked combustion
flask. Add 10 ml of water R and mix. Add 10 ml of sulphuric acid R and boil vigorously, with the
usual precautions, until a clear solution is obtained. Cool, add slowly a cooled mixture of 30 ml
of water R and 10 ml of sulphuric acid R, cool again and dilute to 100.0 ml with water R.
Solution S2 is not more opalescent than reference suspension II and is colorless
Shake 5.0 g with 50 ml of carbon dioxide-free water R for 5 min. Centrifuge or filter until a clear
solution is obtained. To 10 ml of the solution add 0.1 ml of bromothymol blue solution R1. Not
more than 1.0 ml of 0.01 M hydrochloric acid or 0.01 M sodium hydroxide is required to change
the colour of the indicator.
Water-soluble substances:
To 10.0 g add a solution of 0.5 g of ammonium sulphate R in 150 ml of water R and boil for 5
min. Cool, dilute to 200 ml with water R and filter until a clear solution is obtained.
Evaporate 100 ml of the solution to dryness in a tarred evaporating dish and ignite. The residue
weighs not more than 25 mg (0.5 per cent).
Heavy metals:
Dilute 10 ml of solution S1 to 20 ml with water R. 12 ml of the solution complies with limit test
A for heavy metals (20 ppm). Prepare the standard using lead standard solution (1 ppm Pb) R.
Iron:
To 8 ml of solution S2 add 4 ml of water R. Mix and add 0.05 ml of bromine water R. Allow to
stand for 5 min and remove the excess of bromine with a current of air. Add 3 ml of potassium
thiocyanate solution R. Any colour in the solution is not more intense than that in a standard
prepared at the same time in the same manner using a mixture of 4 ml of iron standard solution
(2 ppm Fe) R and 8 ml of a 200 g/l solution of sulphuric acid R (200 ppm).
(PEG 6000)
BP 2014
Objective:
Scope:
Responsibility:
Procedure:
Description:
White or almost white solid with a waxy or paraffin like appearance.
Solubility:
Very soluble in water, soluble in methylene chloride
Practically insoluble in alcohol and in fatty oils and in mineral oils
TESTS:
Identification:
1. To 1 g in a test-tube add 0.5 ml of sulphuric acid, close the test-tube with a stopper fitted with
a bent delivery tube and heat until white fumes are evolved. Collect the fumes via the delivery tube
into 1 ml of mercuric chloride solution R. An abundant white, crystalline precipitate is formed.
2. To 0.1 g add 0.1 g of potassium thiocyanate and 0.1 g of cobalt nitrate and mix thoroughly
with a glass rod. Add 5 ml of methylene chloride and shake. The liquid phase becomes blue.
Melting point: 550C to 630C

pH: 5% w/v solution is 4.5 to 7.5
Acidity or alkalinity: Dissolve 5.0 g in 50 ml of carbon dioxide-free water and add 0.15 ml of
bromothymol blue solution R1. The solution is yellow or green. Not more than 0.1 ml of 0.1 M
sodium hydroxide is required to change the color of the indicator to blue.
Water: Maximum 1.0% determined on 2.0 g.
Isopropyl Alcohol
BP 2014
Vol 1, I-1234
Objective:
Scope:
Responsibility:
Procedure:
Appearance: Clear, colourless liquid
TESTS
Solubility: Miscible with water and with alcohol
Identification
A. Relative density: 0.785 to 0.789.
B. Refractive index: 1.376 to 1.379.
C. to 1 ml adds 2 ml of potassium dichromate solution R and 1 ml of dilute sulphuric acid R.
Boil. Vapour is produced which changes the colour of a piece of filter paper impregnated with
nitrobenzaldehyde solution R to green. Moisten the filter paper with dilute hydrochloric acid R.
The colour changes to blue.
Appearance: The substance to be examined is clear and colourless Dilute 1 ml to 20 ml with

water R. After 5 min, the solution is clear.
Absorbance: Maximum 0.30 at 230nm, 0.10 at 250nm, 0.03 at 270nm, 0.02 at 290nm & 0.01 at
310nm, the absorbance is measured between 230 nm and 310 nm using water R as the
compensation liquid. The absorption curve is smooth.
Non-volatile substances: Maximum 20ppm

Evaporate 100 g to dryness on a water-bath after having verified that it complies with the test for
peroxides and dry in an oven at 100-105 °C. The residue weighs a maximum of 2 mg.
Purified Water
BP 2014
Vol 2, II-1168

Objective:
Scope:
Responsibility:
Procedure:
Definition:
Purified water is water for the preparation of medicines other than those that are required to be both
sterile and apyrogenic, unless otherwise justified and authorised.

Purified water in bulk:
Production
Purified water in bulk is prepared by distillation, by ion exchange or by any other suitable method
from water that complies with the regulations on water intended for human consumption laid down
by the competent authority.

During production and subsequent storage, appropriate measures are taken to ensure that the total
viable aerobic count is adequately controlled and monitored. Appropriate alert and action limits are
set so as to detect adverse trends. Under normal conditions, an appropriate action limit is a total
viable aerobic count (2.6.12) of 100 micro-organisms per millilitre, determined by membrane
filtration, using agar medium S and incubating at 30-35C for 5 days. The size of the sample is to be
chosen in relation to the expected result.

In addition, the test for total organic carbon (2.2.44) with a limit of 0.5 mg/l or alternatively the
following test for oxidisable substances is carried out: to 100 ml add 10 ml of dilute sulphuric acid R
and 0.1 ml of 0.02M potassium permanganate and boil for 5 min. The solution remains faintly pink.

Conductivity (2.2.38) (maximum 4.3µScm-1 at 20C) is also controlled.

Purified water in bulk is stored and distributed in conditions designed to prevent growth of micro-
organisms and to avoid any other contamination.

Characters:
Clear, colourless, odourless and tasteless liquid

Tests
pH: 5.0 to 7.5
Nitrates:
Maximum 0.2 ppm
Place 5 ml in a test-tube immersed in iced water, add 0.4 ml of a 100 g/l solution of potassium
chloride R, 0.1 ml of diphenylamine solution R and, dropwise with shaking, 5 ml of nitrogen-free
sulphuric acid R. Transfer the tube to a water-bath at 50C. After 15 min, any blue colour in the
solution is not more intense than that in a standard prepared at the same time in the same manner
using a mixture of 4.5 ml of nitrate-free water R and 0.5 ml of nitrate standard solution (2 ppm NO3)
R.

Aluminium (2.4.17)
Maximum 10 mg/l, if intended for use in the manufacture of dialysis solutions.
To 400 ml add 10 ml of acetate buffer solution pH 6.0 R and 100 ml of distilled water R. The solution
complies with the limit test for aluminium (10 mg/l). Use as the reference solution a mixture of 2 ml
of aluminium standard solution (2 ppm Al) R, 10 ml of acetate buffer solution pH 6.0 R and 98 ml of
distilled water R. To prepare the blank, use a mixture of 10 ml of acetate buffer solution pH 6.0 R and
100 ml of distilled water R.

Heavy metals (2.4.8):
Maximum 0.1 ppm
Heat 200 ml in a glass evaporating dish on a water-bath until the volume is reduced to 20 ml. 12 ml
of the concentrated solution complies with limit test A. Prepare the standard using 10 ml of lead
standard solution (1 ppm Pb) R.
(Carmellose sodium)
BP 2014
Objective:
Scope:
Responsibility:
Procedure:
Definition: Carmellose sodium (carboxymethylcellulose sodium) is the sodium salt of a partly O-

carboxymethylated cellulose. It contains not less than 6.5 per cent and not more than 10.8 per cent of
sodium (Na), calculated with reference to the dried substance.
Characters: A white or almost white, granular powder, hygroscopic after drying,
Solubility: Practically insoluble in acetone, in ethanol and in toluene / It is easily dispersed in water
giving colloidal solutions.
IDENTIFICATION
A. To 10 mL of solution S (see Tests) add 1 mL of copper sulfate solution R. A blue, cotton-like
precipitate is formed.
B. Boil 5 mL of solution S for a few minutes. No precipitate is formed.

C. The solution prepared from the sulfated ash in the test for heavy metals gives the reactions of
sodium (2.3.1).
TESTS
Solution S: Sprinkle a quantity of the substance to be examined equivalent to 1.0 g of the dried
substance onto 90 mL of carbon dioxide-free water R at 40 °C to 50 °C stirring vigorously. Continue
stirring until a colloidal solution is obtained, cool and dilute to 100 mL with carbon dioxide-free
water R.
Appearance of solution: Solution S is not more opalescent than reference suspension III (2.2.1) and
not more intensely colored than reference solution Y6 (2.2.2, Method II).
pH (2.2.3): The pH of solution S is 6.0 to 8.0.
Apparent viscosity
While stirring, introduce a quantity of the substance to be examined equivalent to 2.00 g of the dried
substance into 50 mL of water R heated to 90 °C. For a product of low viscosity, use if necessary, the
quantity required to give the concentration indicated on the label. Allow to cool, dilute to 100.0 mL
with water R and stir until dissolution is complete.
Determine the viscosity (2.2.10) using a rotating viscometer at 20 °C and a shear rate of 10 s -1. If it is
impossible to obtain a shear rate of exactly 10s -1, use a shear rate slightly higher and a rate slightly
lower and interpolate. The apparent viscosity is not less than 75 per cent and not more than 140 per
cent of the value stated on the label.
Sodium glycollate
Place a quantity of the substance to be examined equivalent to 0.500 g of dried substance in a beaker.
Add 5 mL of acetic acid R and 5 mL of water R. Stir until dissolution is complete (about 30 min).
Add 80 mL of acetone R and 2 g of sodium chloride R. Filter through a fast filter paper impregnated
with acetone R into a volumetric flask, rinse the beaker and filter with acetone R and dilute the
filtrate to 100.0 mL with the same solvent. Allow to stand for 24 h without shaking. Use the clear
supernatant liquid to prepare the test solution.
In a volumetric flask, dissolve 0.310 g of glycollic acid R, previously dried in vacuo over
diphosphorus pentoxide R, in water R and dilute to 1000.0 mL with the same solvent. Place 5.0 mL
of this solution in a volumetric flask, add 5 mL of acetic acid R and allow to stand for about 30 min.
Add 80 mL of acetone R and 2 g of sodium chloride R and dilute to 100.0 mL with acetone R. Use
this solution to prepare the reference solution.
Place 2.0 mL of each solution in a separate 25 mL volumetric flask. Heat on a water-bath to eliminate
acetone. Cool to room temperature and add 5.0 mL of 2,7- dihydroxynaphthalene solution R to each
flask. Shake and add 15.0 mL of 2,7- dihydroxynaphthalene solution R. Close the flasks with
aluminium foil and heat on a water-bath for 20 min. Cool under running water and dilute to 25.0 mL
with sulfuric acid R. Within 10 min, transfer 10.0 mL of each solution to a flat-bottomed tube.
Examine the solutions viewing vertically. The test solution is not more intensely colored than the
reference solution (0.4 per cent).
Chlorides (2.4.4): Dilute 2 mL of solution S to 15 mL with water R. The solution complies with the
limit test for chlorides (0.25 per cent).
Heavy metals (2.4.8): To the residue obtained in the determination of the sulfated ash, add 1 mL of
hydrochloric acid R and evaporate on a water-bath. Take up the residue in 20 mL of water R. 12 mL
of the solution complies with limit test A for heavy metals (20 ppm). Prepare the standard using lead
standard solution (1 ppm Pb) R.
Loss on drying (2.2.32): Not more than 10.0 per cent, determined on 1.000 g by drying in an oven at
105 °C.
Sulfated ash (2.4.14): 20.0 per cent to 33.3 percent determined on 1.0 g using a mixture of equal
volumes of sulfuric acid R and water R and calculated with reference to the dried substance. These
limits correspond to a content of 6.5 per cent to 10.8 per cent of sodium (Na).
Xanthan gum
BP 2014
Objective:
Scope:
Responsibility:
Procedure:
Characters: A white or yellowish-white, free-flowing powder, soluble in water giving a highly

viscous solution, practically insoluble in organic solvents.
Identification: A. In a flask suspends 1 g in 15 ml of 0.1M hydrochloric acid. Close the flask with a
fermentation bulb containing barium hydroxide solution R and heat carefully for 5 min. The barium
hydroxide solution shows a white turbidity.
pH (2.2.3). The pH of a 10.0 g/l solution is 6.0 to 8.0.
Viscosity (2.2.10) the viscosity at 24 ± 1°C is not less than 600 mPas. Add 3.0 g within 45 s to 90 s
into 250 ml of a 12 g/l solution of potassium chloride R in a 500 ml beaker stirring with a low-pitch
propeller-type stirrer rotating at 800r/min. When adding the substance take care that agglomerates are
destroyed. Add an additional quantity of 44 ml of water R, to rinse any adhering residue from the
walls of the beaker. Stir the preparation at 800r/min for 2 h whilst maintaining the temperature at 24
± 1°C. Determine the viscosity within 15 min using a rotating viscosimeter set at 60r/min and
equipped with a rotating spindle 12.7 mm in diameter and 1.6 mm high which is attached to a shaft
3.2 mm in diameter. The distance from the top of the cylinder to the lower tip of the shaft being
25.4mm, and the immersion depth being 50.0mm
Loss on drying (2.2.32) not more than 15.0 per cent, determined on 1.000 g by drying in an oven at
100°C to 105°C for 2.5 h.
Sodium benzoate
BP 2014
Objective:
Scope:
Responsibility:
Procedure:
Appearance:
A white, crystalline or granular powder or flakes, slightly hygroscopic,
Solubility:
Freely soluble in water, sparingly soluble in alcohol (90 per cent V/V)
Identifications:
A. It gives reactions (b) and (c) of benzoates (2.3.1).
B. It gives the reactions of sodium (2.3.1).
Tests:
Solution S:
Dissolve 10.0 g in carbon dioxide-free water R and dilute to 100 ml with the same solvent.
Solution S is clears (2.2.1) and not more intensely colored than reference solution Y6
To 10 ml of solution S add 10 ml of carbon dioxide-free water R and 0.2 ml of phenolphthalein
solution R. Not more than 0.2 ml of 0.1M sodium hydroxide or 0.1M hydrochloric acid is required to
change the colour of the indicator.
Loss on drying:
Not more than 2.0 per cent, determined on 1.00 g by drying in an oven at 100°C to 105°C.
Sieve Analysis 60 mesh:

Take 5gm of powder and pas through 60 number meshes, note the weight of powder passed through
sieve and calculate the %age powder passed or retained.
NLT 60% Should Passed
Bulk Density:
Take 5gm of powder in graduated cylinder and note the volume of powder, now calculate bulk
density by the formula
Bulk Density = mass/volume

Limits: 0.320gm/ml---------0.390gm/ml
Tapped Density:
Take 5gm of powder in graduated cylinder and tapped 100 times note the volume of powder, now
calculate Tapped density by the formula
Tapped Density = mass/volume

Limits: 0.550gm/ml-------------0.620gm/ml
Assay:
Dissolve 0.250 g in 20 ml of anhydrous acetic acid R, heating to 50°C if necessary. Cool. Using 0.05
ml of naphtholbenzein solution R as indicator, titrate with 0.1M perchloric acid until a green colour is
obtained.
1 ml of 0.1M perchloric acid is equivalent to 14.41 mg of C7H5NaO2.
Aspartame
BP 2014
Vol 1, Page # I-198
Objective:
Scope:
Responsibility:
Procedure:
Identification:
Dissolve 100mg in alcohol and dilute to 100ml with the same solvent .examine between 230nm and
300nm the solution shows absorption maxima at 247nm, 252nm, 258nm and 264nm
Solution S:
Dissolve 15mg in 2.5 ml of water and dilute to 10 ml with acetic acid
Solution s is clear
Loss on Drying:
NMT 4.5 %

sieve and calculate the %age passed or retained.
NLT 90% Should Passes
Bulk Density:
Limits:
0.200gm/ml--------0.260gm/ml
Tapped Density:
Limits:
0.300gm/ml--------0.35gm/ml
Assay:
Dissolve 250mg in 1.5 ml of anhydrous formic acid and 60ml of glacial acetic acid .Titrate with 0.1M
hclo4 determining the end point potentiometrically. 1ml of 0.1 M hclo4 is = 29.43 mg of aspartame
%age =volume used x Factor x 100/weight of sample in mg
Limits: 98% ------------102%

Saccharin sodium
BP 2014
Objective:
Scope:
Responsibility:
Procedure:
Content
It may contain a variable quantity of water.
Appearance
White or almost white, crystalline powder or colourless crystals, efflorescent in dry air
Solubility
Freely soluble in water, sparingly soluble in ethanol (96 per cent)
TESTS
IDENTIFICATION
A. Melting point: 226 °C to 230 °C.
To 5 ml of solution S (see Tests) add 3 ml of dilute hydrochloric acid R. A white precipitate is
formed. Filter and wash with water R. Dry the precipitate at 100-105 °C.
B To 0.2 g add 1.5 ml of dilute sodium hydroxide solution R, evaporate to dryness and heat the
residue carefully until it melts, avoiding carbonization. Allow to cool, dissolve the mass in about 5 ml
of water R, add dilute hydrochloric acid R until a weak acid reaction is produced and filter, if
necessary. To the filtrate add 0.2 ml of ferric chloride solution R2. A violet colour develops.
C. Solution S gives reaction (a) of sodium.
Solution S
Dissolve 5.0 g in carbon dioxide-free water R and dilute to 50.0 ml with the same solvent.
Appearance of solution
The solution is clear and colourless
Dissolve 5.0 g in 25 ml of carbon dioxide-free water R.
Acidity or alkalinity
To 10 ml of solution S add about 0.05 ml of a 1 per cent m/V solution of phenolphthalein R in
ethanol (96 per cent) R. The solution is not pink. Add 0.1 ml of sodium hydroxide 0.1 M. The
solution becomes pink.
Heavy metals
Maximum 20 ppm
12 ml of solution S complies with test A. Prepare the reference solution using lead standard solution
(2 ppm Pb) R.
Water
Maximum 15.0 per cent, determined on 0.200g
ASSAY
Dissolve 0.150 g in 50 ml of anhydrous acetic acid R, with slight heating if necessary. Titrate with
0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20). Carry out a blank
titration. 1 ml of 0.1 M perchloric acid is equivalent to 20.52 mg of C7H4NNaO3S.
Sodium citrate
BP 2014
Objective:
Scope:
Responsibility:
Procedure:
CHARACTERS
A white, crystalline powder or white, granular crystals, slightly deliquescent in moist air, freely
soluble in water, practically insoluble in alcohol
IDENTIFICATION
A. to 1 ml of solution S (see Tests add 4 ml of water R
The solution gives the reaction of citrates (2.3.1).
B. 1 ml of solution S gives reaction (a) of sodium (2.3.1).
TESTS
Solution S: Dissolve 10.0 g in carbon dioxide-free water R prepared from distilled water R and dilute
to 100 ml with the same solvent.
Appearance of solution: Solution S is clear (2.2.1) and colourless (Method II, 2.2.2).
Water (2.5.12): 11.0 per cent to 13.0 per cent, determined on 0.300 g by the semi-micro
determination of water. After adding the substance to be examined, stir for 15 min before titrating.
ASSAY: Dissolve 0.150 g in 20 ml of anhydrous acetic acid R, heating to about 50°C. Allow to
cool. Using 0.25 ml of naphtholbenzein solution R as indicator, titrate with 0.1M perchloric acid until
a green colour is obtained. 1 ml of 0.1M perchloric acid is equivalent to 8.602 mg of C6H5Na3O7
Assay limit: 99% ---- 101%
Citric Acid
BP 2014
Vol 1, Page # I-560
Objective:
Scope:
Responsibility:
Procedure:
Definition:
Citric acid contains not less than 99.5 per cent and not more than the equivalent of 100.5 per cent of
2-hydroxypropane-1, 2, 3-tricarboxylic acid, calculated with reference to the anhydrous substance.
Characters:
A white, crystalline powder, colourless crystals or granules, efflorescent, very soluble in water, freely
soluble in alcohol
TESTS
IDENTIFICATION
A. Dissolve 1 g in 10ml of water R, the solution is strongly acidic.
B. Add about 5 mg to a mixture of 1 ml of acetic anhydride R and 3 ml of pyridine R. A red colour

develops.
C. Dissolve 0.5 g in 5 ml of water R, neutralize using 1 M sodium hydroxide (about 7 ml), add 10 ml
of calcium chloride solution R and heat to boiling. A white precipitate is formed.
Dissolve 2.0 g in water R and dilute to 10 ml with the same solvent.
The solution is clear and not more intensely colored than reference solution.
Sulphates:
Dissolve 2.0 g in distilled water R and dilute to 30 ml with the same solvent.
The solution complies with the limit test for sulphates (150 ppm).
Sulphated ash:
Not more than 0.1 per cent, determined on 1.0 g.
ASSAY:
Dissolve 0.550 g in 50 ml of water R. Titrate with 1 M sodium hydroxide, using 0.5 ml of
phenolphthalein solution R as indicator. 1 ml of 1 M sodium hydroxide is equivalent to 64.03 mg of
C6H8O7.
Sucrose
(Refined Sugar)
BP 2014
Objective:
Scope:
Responsibility:
Procedure:
Appearance:
White or almost white crystalline powder or lustrous colorless or white or almost white crystals
Solubility:
Very Soluble in water, slightly soluble in ethanol, practically insoluble in anhydrous ethanol
Tests:
Identifications:
Solution S:
Dissolve 50.0g in water and dilute to 100 ml with the same solvent.
A: Dilute 1ml of soln s to 100ml with water. To 5ml of the soln add 0.15ml freshly prepared copper
Sulphate solution R and 2 ml of freshly prepared dilute sodium hydroxide. R. The solution is blue and
clear and remains so after boiling. To the hot solution add 4ml of dilute hydrochloric acid R and boil
for 1min.Add 4ml of dilute sodium hydroxide Solution R .An orange precipitate is formed
immediately.
Specific optical rotation:

+66.3 to +67.0
Dissolve 26.0g in water and dilute to 100ml with same solvent.
Loss on drying:
Not more than 0.1 per cent, determined on 2.000 g by drying in an oven at 100 °C to 105 °C.

sieve and calculate the %age powder passed or retained.
NLT 60% Should Passed
Bulk Density:

Limits: 0.800gm/ml---------0.860gm/ml
Tapped Density:

Limits: 0.880gm/ml-------------0.960gm/ml
Dextrose
(In-house)
Objective:
Scope:
Responsibility:
Procedure:
CHARACTERS
Appearance:
White or almost white, crystalline powder
Solubility:
Freely soluble in water, sparingly soluble in ethanol (96 per cent)
TESTS
Solution
Dissolve 50.0 g in water R and dilute to 100 mL with the same solvent.
Solution is clear
Specific optical rotation

+ 52.5º to + 53.3º.
Sulfites
Maximum 15 ppm, calculated as SO2.
Determine the sulfites content by a suitable enzymatic method based on the following reactions.
Sulfite is oxidised by sulfite oxidase to sulfate and hydrogen peroxide which in turn is reduced by
nicotinamide-adenine dinucleotide-peroxidase in the presence of reduced nicotinamide-adenine
dinucleotide (NADH). The amount of NADH oxidised is proportional to the amount of sulfite.
Test solution:
Dissolve 4.0 g of the substance to be examined in freshly prepared distilled water R and dilute to 10.0
mL with the same solvent.
Reference solution:
Dissolve 4.0 g of the substance to be examined in freshly prepared distilled water R, add 0.5 mL of
sulfite standard solution (80 ppm SO2) R and dilute to 10.0 mL with freshly prepared distilled water
R.
Blank solution:
Freshly prepared distilled water R.
Separately introduce 2.0 mL each of the test solution, the reference solution and the blank in 10 mm
cuvettes and add the reagents as described in the instructions in the kit for sulfite determination.
Measure the absorbance (2.2.25) at the absorption maximum at about 340 nm before and at the end of
the reaction time and subtract the value obtained with the blank.
The absorbance difference of the test solution is not greater than half the absorbance difference of the
reference solution.
Water
Maximum 1.0 per cent, determined on 2.000 g by drying in an oven at 105 °C for 3 h.
Bacterial endotoxins
Less than 1.25EU/g
LABELLING
The label states, where applicable, that the substance is suitable for use in the manufacture of large-
volume parenteral preparations.
Sorbitol
BP 2014
(BP 2014, Volume # 2, Page # II-886)
Objective:
Scope:
Responsibility:
Procedure:
Content
CHARACTERS
Appearance: White or almost white, crystalline powder
Solubility: Very soluble in water, practically insoluble in ethanol (96 per cent)
It shows polymorphism (5.9).
IDENTIFICATION
First identification A
Second identification B, C, D
A. Examine the chromatograms obtained in the assay.

Results the principal peak in the chromatogram obtained with the test solution is similar in retention
time and size to the principal peak in the chromatogram obtained with reference solution (a).
B. Dissolve 0.5 g with heating in a mixture of 0.5 mL of pyridine R and 5 mL of acetic anhydride R.
After 10 min, pour the solution into 25 mL of water R and allow standing in iced water for 2 h. The
precipitate recrystallised from a small volume of ethanol (96 per cent) R and dried in vacuo, melts
(2.2.14) at 98 °C to 104 °C.
C. Thin-layer chromatography (2.2.27).

Test solution Dissolve 25 mg of the substance to be examined in water R and dilute to 10 mL with
the same solvent.
Reference solution (a) Dissolve 25 mg of sorbitol CRS in water R and dilute to 10 mL with the
same solvent.
Reference solution (b) Dissolve 25 mg of mannitol CRS and 25 mg of sorbitol CRS in water R
and dilute to 10 mL with the same solvent.
Plate TLC silica gel G plate R.
Mobile phase water R, ethyl acetate R, propanol R (10:20:70 V/V/V).

Application 2 µL
Development Over a path of 17 cm
Drying In air
Detection Spray with 4-aminobenzoic acid solution R; dry in a current of cold air until the acetone
is removed; heat at 100 °C for 15 min; allow to cool and spray with a 2 g/L solution of sodium
periodate R; dry in a current of cold air; heat at 100 °C for 15 min.
System suitability Reference solution (b):

The chromatogram shows 2 clearly separated spots.
Results the principal spot in the chromatogram obtained with the test solution is similar in position,
colour and size to the principal spot in the chromatogram obtained with reference solution (a).
D. Specific optical rotation (2.2.7): + 4.0 to + 7.0 (anhydrous substance).

Dissolve 5.00 g of the substance to be examined and 6.4 g of disodium tetraborate R in 40 mL of
water R. Allow to stand for 1 h, shaking occasionally, and dilute to 50.0 mL with water R. Filter if
necessary.
TESTS
Appearance of solution: The solution is clear (2.2.1) and colourless (2.2.2, Method II).
Dissolve 5 g in water R and dilute to 50 mL with the same solvent.
Conductivity (2.2.38): Maximum 20 µS·cm-1

Dissolve 20.0 g in carbon dioxide-free water R prepared from distilled water R and dilute to 100.0
mL with the same solvent. Measure the conductivity of the solution while gently stirring with a
magnetic stirrer.
Reducing sugars: Maximum 0.2 per cent, expressed as glucose equivalent.

Dissolve 5.0 g in 6 mL of water R with the aid of gentle heat. Cool and add 20 mL of cupri-citric
solution R and a few glass beads. Heat so that boiling begins after 4 min and maintain boiling for 3
min. Cool rapidly and add 100 mL of a 2.4 per cent V/V solution of glacial acetic acid R and 20.0 mL
of 0.025 M iodine. With continuous shaking, add 25 mL of a mixture of 6 volumes of hydrochloric
acid R and 94 volumes of water R and, when the precipitate has dissolved, titrate the excess of iodine
with 0.05M sodium thiosulfate using 1 mL of starch solution R, added towards the end of the
titration, as indicator. Not less than 12.8 mL of 0.05 M sodium thiosulfate is required.
Lead (2.4.10: Maximum 0.5 ppm

Nickel (2.4.15): Maximum 1 ppm
Dissolve the substance to be examined in 150.0 mL of the prescribed mixture of solvents.
Water (2.5.12): Maximum 1.5 per cent, determined on 1.00 g
Mannitol
BP 2014
(Volume # 2, Page # II-189)
Objective:
Scope:
Responsibility:
Procedure:
DEFINITION
D-Mannitol
CHARACTERS
Appearance
White or almost white, crystalline powder or free-flowing granules
Solubility
Freely soluble in water, very slightly soluble in ethanol (96 per cent)
It shows polymorphism (5.9).
IDENTIFICATION
First identification C
Second identification A, B, D
A. Specific optical rotation (2.2.7): + 23 to + 25 (anhydrous substance).
Dissolve 2.00 g of the substance to be examined and 2.6 g of disodium tetraborate R in about 20 mL
of water R at 30 °C; shake continuously for 15-30 min without further heating. Dilute the resulting
clear solution to 25.0 mL with water R.
B. Melting point (2.2.14): 165 °C to 170 °C.

C. Infrared absorption spectrophotometry (2.2.24).
Preparation Discs
Comparison mannitol CRS
If the spectra obtained in the solid state show differences, dissolve separately in 2 glass vials 25 mg
of the substance to be examined and 25 mg of the reference substance in 0.25 mL of distilled water R
without heating. The solutions obtained are clear. Evaporate to dryness by heating in a microwave
oven with a power range of 1000-1300 W for 15-30 min or by heating in an oven in vacuo at 100 °C.
Non-sticky, white or slightly yellowish powders are obtained. Record new spectra using the residues
D. Thin-layer chromatography (2.2.27).

Test solution Dissolve 25 mg of the substance to be examined in water R and dilute to 10 mL with
the same solvent.
Reference solution (a) Dissolve 25 mg of mannitol CRS in water R and dilute to 10 mL with the
same solvent.
Reference solution (b) Dissolve 25 mg of mannitol R and 25 mg of Sorbitol R in water R and

dilute to 10 mL with the same solvent.
Plate TLC silica gel G plate R.

Mobile phase water R, ethyl acetate R, propanol R (10:20:70 V/V/V).
Application 2 µL
Development Over 2/3 of the plate
Drying In air
Detection Spray with 4-aminobenzoic acid solution R. Dry in a current of cold air until the acetone
is removed. Heat at 100 °C for 15 min. Allow to cool and spray with a 2 g/L solution of sodium
periodate R. Dry in a current of cold air. Heat at 100 °C for 15 min
System suitability Reference solution (b):

— The chromatogram shows 2 clearly separated spots.
Results: the principal spot in the chromatogram obtained with the test solution is similar in position,
colour and size to the principal spot in the chromatogram obtained with reference solution (a).
TESTS
The solution is clear (2.2.1) and colorless (2.2.2, Method II).
Dissolve 5.0 g in water R and dilute to 50 mL with the same solvent.
Conductivity (2.2.38)
Maximum 20 µS·cm-1
Dissolve 20.0 g in carbon dioxide-free water R prepared from distilled water R by heating at 40-50
°C and dilute to 100.0 mL with the same solvent. After cooling, measure the conductivity of the
solution while gently stirring with a magnetic stirrer.
Reducing sugars
Maximum 0.2 per cent (calculated as glucose equivalent).
Dissolve 5.0 g in 25 mL of water R with the aid of gentle heating. Cool and add 20 mL of cupri-citric
solution R and a few glass beads. Heat so that boiling begins after 4 min and maintain boiling for 3
min. Cool rapidly and add 100 mL of a 2.4 per cent V/V solution of glacial acetic acid R and 20.0 mL
of 0.025 M iodine. With continuous shaking, add 25 mL of a mixture of 6 volumes of hydrochloric
acid R and 94 volumes of water R and, when the precipitate has dissolved, titrate the excess of iodine
with 0.05 M sodium thiosulfate using 1 mL of starch solution R, added towards the end of the
titration, as indicator. Not less than 12.8 mL of 0.05 M sodium thiosulfate is required.
Lead (2.4.10)
Maximum 0.5 ppm
Dissolve the substance to be examined in 150.0 mL of the prescribed mixture of solvents
Nickel (2.4.15)
Maximum 1 ppm
Dissolve the substance to be examined in 150.0 mL of the prescribed mixture of solvents.
Water (2.5.12)
Maximum 0.5 per cent determined on 1.00 g. Use as solvent 40 mL of a mixture of equal volumes of
anhydrous methanol R and formamide R at about 50 °C.
Methanol
(BP 2014)
(Volume # 2, Page # II-238)
Objective:
Scope:
Responsibility:
Procedure:
DEFINITION
Methyl alcohol
CHARACTERS
Appearance
Clear, colourless, volatile, hygroscopic liquid
Solubility
Miscible with water and with methylene chloride
Boiling Point
About 64 °C
It is flammable.
IDENTIFICATION
A. Refractive index (2.2.6): 1.328 to 1.330.
B. Infrared absorption spectrophotometry (2.2.24).
Comparison Ph. Eur. reference spectrum of methanol.
TESTS
Appearance
It is clear (2.2.1) and colorless (2.2.2, Method II).
Acidity or alkalinity
To 25 mL add 25 mL of water R and 0.25 mL of phenolphthalein solution R1. The solution is
colorless. Not more than 0.9 mL of 0.01 M sodium hydroxide is required to change the colour of the
indicator to pink.
Relative density (2.2.5)

0.791 to 0.793
Absorbance (2.2.25)
Maximum 0.15 at 230 nm, maximum 0.05 at 250 nm, maximum 0.02 at 270 nm and maximum 0.01
at 290 nm.
Examine between 230 nm and 290 nm using water R as the compensation liquid. The absorption
curve is smooth.
Reducing substances
To 20 mL add 0.1 mL of 0.02 M potassium permanganate. The pink colour is not completely
discharged within 5 min.
Residue on evaporation
Maximum 10 ppm
Evaporate 100 g to dryness on a water bath and dry in an oven at 100-105 °C. The residue weighs a
maximum of 1 mg.
Water (2.5.12)
Maximum 0.10 per cent, determined on 10.0 g

STORAGE
In an airtight container
Hard Gelatin Capsule Shell

(In-house)
Objective:
Scope:
Responsibility:
Procedure:
Physical Parameter
Description:
Hard gelatin capsule shell
Disintegration time:
Note the disintegration time in 900ml of distilled water (NMT 30 min)
Loss on drying:
Between 12%----- 15% at 105 c˚
Size:
Note the size of the shell (must be matched with standard)
Colour:
Note the Colour of the cap and body (must be matched with standard)
Weight variation:
Note the individual weight of 20 shells (should be ±10%)
CERTIFICATE OF ANALYSIS
INACTIVE PHARMACEUTICAL INGREDIENT

(Pvp k30)
BP 2014
Material/Item: Batch No
PVP K 30 P141114005-0
Status: Raw material Batch Size/Quantity: 1000Kg
Mfg .Date: 14-11-2014 Supplier: Boai NKY Pharma Ltd, China
Exp. Date:13-11-2017 Receiving Date: 26-12-2014
Analysis Date:26-12-2014 Q.C No:315RM1214
GRN NO:209RM Retest Date:25-12-2015
S# Description Result Specifications

1 Appearance White powder White powder
2 Solubility Complies soluble in water and ethanol
3 Identification +ve Conforms
4 LOD 2.36% NMT 5%
5 Bulk Density 0.401 g/ml 0.400 - 0.430g/ml
6 Tapped Density 0.496g/ml 0.485 - 0.510g/ml
Remarks: Results complies with the Specifications so released for production
Corn Starch
BP 2014
Maize corn starch
Status: Raw material Batch Size/Quantity: 50kg
Mfg .Date: Supplier: Multi chemical rwp
Exp. Date: Receiving Date: 17-03-2015
Analysis Date: 17-03-2015 Q.C No: 459RM0315
GRN NO: RM 315 Retest Date: 16-03-2016

White color free flowing
White color free flowing
1 Appearance
powder. powder.
2 Solubility Complies Insoluble in water

Complies Maize corn starch must be
3 Identification
positive
4 PH 4.8 4.0 To 5.0
5 LOD 13.9% 12.0 To 14.0%
Lactose monohydrate
BP 2014
Vol 2, Page # II-65
Lactose monohydrate 8513022314
Mfg .Date: 23-03-2013 Supplier: Foremost Farms Cooperativ, USA
Exp. Date: 23-02-2016 Receiving Date: 07-09-2014
GRN NO:RM093 Retest Date:07-09-2015

Freely but slowly soluble in
2 Solubility Soluble in water water. Insoluble in ethanol
(96%)
4 Optical Rotation +54.4 +54.4 - +55.9
5 Water 5% 4.5 - 5.5%
6 Bulk Density 0.502 g /cm3 NMT 0.540 g /cm3
7 Tapped Density 0.717 g /cm3 NMT 0.800 g /cm3
Lactose SD
BP 2014
Vol 2, Page # II-66
Lactose SD 8514082761
Mfg .Date: 27-08-2014 Supplier: Foremost farms cooperative ,USA
Analysis Date: 24-11-2014 Q.C No:227RM01114

1 Appearance White Crystalline powder White Crystalline powder
2 Solubility Slightly soluble in Water Slightly soluble in Water
4 Water/LOD 0.8% NMT 1%
NMT0.4ml of 0.1N NaOH is
5 Acidity/Alkalinity 0.1ml
required to change colour
6 Bulk Density 0.660 g /cm3 NMT 0.670 g / cm3
7 Tapped Density 0.765 g / cm3 NMT 0.780 g / cm3
(Avicel 102)
BP 2014
Vol 1, Page # I-468
Avicel 102 B 4610249847
Supplier: JRS Pharma GMBH & CO.KG
Mfg .Date: 11-2014
Germany
Exp. Date: 11-2019 Receiving Date: 11-02-2015

1 Appearance White crystalline powder White crystalline powder
2 Solubility Insoluble in water Insoluble in water
4 PH 6.79 5.0 – 7.5
5 LOD 7% NMT 7%
6 Bulk Density 0.310 g/ml 0.280 – 0.330g/ml
7 Tapped Density 0.450g/ml 0.330 – 0.550g/ml
(Primojel)
BP 2014
Primojel 140520
Supplier: Hangzhou Starshine Pharmaceuticals
Mfg .Date: 22-05-2014
Co Ltd China

White fine free flowing White fine free flowing
1 Appearance
powder powder
Gives Translucent
2 Solubility Complies
Suspension in Water
4 PH 6.4 5.5 – 7.5
5 LOD 5.3% NMT 10%
Crosscarmilose Sodium
BP 2014
Croscarmellose sodium 20814018
Mfg .Date: AUG-2014 Supplier: Multi chemical RWP
Exp. Date: JULY-2019 Receiving Date: 03-03-2015
GRN NO: Rm 292 Retest Date: 02-03-2016

White color free flowing White color free flowing
1 Appearance
powder. powder.
Insoluble in ethanol,
dispersible in water
Croscarmellose sodium must
3 Identification Complies
be positive
4 PH 5.9 5.0 TO 7.0
5 LOD 4.7% NMT 10%
6 Bulk density 0.496g/ml 0.39 To 0.526g/ml
7 Tapped density 0.637g/ml 0.6 To 0.726g/ml
8 Sieve analysis 60 mesh 97.85% NLT 90%
Kyron T-314
(In-house)
Kyron T-314 04013037
Mfg .Date: SEP-2013 Supplier: Sabcon chemical
Exp. Date: AUG-2018 Receiving Date: 24-03-2015

Off- white free flowing
White to off-white free
1 Appearance
powder. flowing powder.
2 Solubility Complies Insoluble in water

Complies Kyron T-314 must be
3 Identification
positive
4 LOD 9.73% NMT 10%
5 Bulk density 0.750 g/ml 0.720 To 0.800g/ml
6 Tapped density 0.860g/ml 0.860 To 0.920g/ml
7 Compressibility index 12.79% 1 To 15 (GOOD)
(Aerosil 200)
BP 2014
Aerosil 200 HN02190113
Status: Raw material Batch Size/Quantity: 20 Kg
Mfg .Date: 09-2014 Supplier: Wacker Chemie A.G.81737 munchen, Germany

Alight ,fine, white or
Alight ,fine, white or almost
1 Appearance almost white amorphous
white amorphous powder
powder
Insoluble in water and in
2 Solubility Complies mineral acids except
hydrofluoric acid
Reactions of silicates must
3 Identification Positive
positive
PH of 1gram in 30 ml
4 4.27 3.5 – 5.5
water suspension
5 Loss on ignition 3.7 % NMT 5.0%
6 Chlorides 196 ppm NMT 250 ppm
7 Heavy metals 18 ppm NMT 25 ppm
Talc
BP 2014
Talc LSQ-338
Mfg .Date: 02-01-2014 Supplier: Brother Enterprise PVT Ltd Karachi

2 Solubility Complies Insoluble in Water
4 PH 7.1 7 – 10
Magnesium stearate
BP 2014
Magnesium stearate C15
Supplier: Coin Power International Co ,Ltd
Mfg .Date: 15-03-2014
Taiwan

White powder, greasy to
1 Appearance White powder, greasy to touch
touch
2 Solubility Complies Insoluble in Water
4 Water/LOD 4.9% NMT6%
(SLS)
BP 2014
Sodium Lauryl Sulphate 00818362
Mfg .Date: Apr-11-2014 Supplier: Multi chemical rwp
Exp. Date: APR-16-2017 Receiving Date: 17-03-2015

GRN NO: RM315 Retest Date: 16-03-2016

White powder. White or pale yellow
1 Appearance
powder.
Freely soluble in water
giving an opalescent
2 Solubility Complies solution, partly soluble in
ethanol
(96 percent).
Complies Sodium Lauryl Sulphate
3 Identification
must be positive
4 Alkalinity Complies conform
Prosolv SMCC 50
(In-house)
Silicified Microcrystalline Cellulose P5S3071
Mfg .Date: 07-2013 Supplier: JRS Pharma, Germany
Analysis Date: 16-02-2015 Q.C No: 230MS15

White to almost white fine or White to almost white fine or
1 Appearance granular powder granular powder
Dispersible in water producing a
white, opaque colloidal
2 Solubility Complies dispersion; practically insoluble
in organic solvents and in dilute
acids.
4 pH 6.0 5.7– 7.0
5 LOD 4.2% NMT 6%
6 Bulk Density 0.319g/ml 0.25g/ml - 0.37g/ml
7 Tapped Density 0.377g/ml 0.37g/ml - 0.500g/ml
Pruv
BP 2014
Sodium Stearyl Fumarate 1136
Mfg .Date: 06-2014 Supplier: JRS Pharma
Analysis Date: 16-02-2015 Q.C No: 232MS15


White to almost white fine or
1 Appearance White granular powder
granular powder
Practically insoluble in water,
Slightly soluble in methanol,
2 Solubility Complies Practically insoluble in acetone and
in ethanol
3 Water 4.11% NMT 5%
Particle size:
4 200Mesh
92.06% Retained NLT 90% should retained
Bulk Density
5 Density
0.3209g/ml 0.290g/ml to 0.370g/ml
Tapped Density
6 Density
0.4011g/ml 0.370g/ml to 0.470g/ml
7 Compressibility index 19.99% (16%-20%) (Fair)
8 Hausner Ratio 1.25 1.19-------1.25 (Fair)
(HPMC E5)
BP 2014
HPMC E5 3C03012 N23
Supplier: The Dow Chemical Company
Mfg .Date: 25-06-2014
Midland, USA


2 Solubility Soluble in cold water Soluble in cold water
4 PH 5.6 5.5-8.0
5 Water/LOD 2.7% NMT 5%
6 Bulk Density 0.420 g/ml 0.40-0.440g/ml
7 Tapped Density 0.505g/ml 0.490-0.520g/ml
Titanium dioxide
BP 2014
Titanium Dioxide 66567
Mfg .Date: 06 -2014 Supplier: Kronos Titanox Germany
Exp. Date: 06- 2017 Receiving Date: 15-09-2014

Insoluble in water and Insoluble in water and Slowly
2 Solubility Slowly soluble in hot soluble in hot concentrated
concentrated H2SO4 H2SO4
NMT 1 ml of 0.01N NaOH is
4 Acidity/Alkalinity 0.6 ml
required to change the colour
(PEG 6000)
BP 2014
PEG 6000 20140925
Mfg .Date: 09-2014 Supplier: Lotte Chemical Korea
Exp. Date: 09- 2017 Receiving Date: 04-12-2014


1 Appearance White crystals or flakes White crystals or flakes
2 Solubility Complies soluble in water
4 PH 6.25% 4.5 – 7.5
5 Melting point 630 C 550 C - 630 C
Isopropyl Alcohol
BP 2014
Vol 1, I-1234
Isopropyl Alcohol 256310
Status: Raw material Batch Size/Quantity: 600L
Mfg .Date: 12-2014 Supplier: Taiwan


Clear colorless Volatile
liquid
2 Solubility Miscible with water Miscible with water
4 RI 1.3766 1.376 – 1.379
5 Water 0.3% NMT 0.5%
6 Specific Gravity 0.787 0.785 – 0.789
Purified Water
BP 2014
Vol 2, II-1168
Distilled Water 0301
Status: Raw material Batch Size/Quantity: 100Liter
Mfg .Date: 31-03-2015 Supplier: Genome Pharma Hattar


Clear, colorless, odorless,
1 Appearance Complies
and tasteless liquid.
2 pH 6.3 5.0 to 7.0
Any turbidity formed within
3 Chloride Negative 10 min should not be greater
than control.
The solution remains faintly
4 positive
Oxidisable Substances pink
The solution shows no
5 Sulphates positive change in appearance for at
least 1 h.
A pure blue color is
6 Calcium and Magnesium positive
produced.
maximum of 1 mg for
7 Residue on Evaporation 1mg/100ml
100 ml
8 Clarity complies Solution is clear
(Carmellose Sodium)
BP 2014
Vol 1, Page # I-412
Carmellose Sodium
Mfg .Date: 25-05-2013 Supplier: Multi chemicals


1 Appearance White powder White to off white powder
Insoluble in
acetone ,Dispersible in water
Carmellose sodium must be
positive
4 LOD 3.2% NMT 10%
5 Bulk density 0.489gm/ml 0.39gm/ml---0.526gm/ml
6 Tapped density 0.67gm/ml 0.6gm/ml---0.726gm/ml
7 Sieve analysis 60 mesh 98.99% NLT 90% Passes
Xanthan gum
BP 2014
Xanthan Gum 12140519
Mfg .Date: 02-04-2014 Supplier: Multi chemicals


1 Appearance off white powder White or off white powder
Soluble in water giving
viscous liquid
Xanthan Gum Must be
positive
4 PH 6.9 6.0 To 8.0
5 LOD 10% NMT 15%
Sodium benzoate
BP 2014
Sodium benzoate TTWR20130728
Mfg .Date: 28-JULY-2013 Supplier: Multi chemical rwp
Exp. Date: 27-JULY-2015 Receiving Date: 13-03-2015

1 Appearance White color powder. White color powder.

2 Solubility Complies Soluble in water
Complies Sodium benzoate must be
3 Identification
positive
4 LOD 0.3% NMT 2%
5 Bulk density 0.3596g/ml _
6 Tapped density 0.4495g/ml _
7 Compressibility index 20.0% 16 To 20 Fair
Aspartame
BP 2014
Vol 2, Page # I-198
Aspartame 14041702
Mfg .Date: Apr-11-2014 Supplier: Multi chemical rwp
Exp. Date: APR-16-2017 Receiving Date: 17-03-2015


1 Appearance White crystalline powder. White crystalline powder.
2 Solubility Complies Slightly soluble in water
3 Identification Complies Aspartame must be positive
4 PH 4.8 4.5 To 6.0
5 LOD 2.2% NMT 4.5%
8 Compressibility index 20.27 16 To 20 (FAIR)
9 Assay 99.10% 98 To 102 %
Saccharin sodium
BP 2014
Saccharin Sodium 120215
Mfg .Date: 13-03-2013 Supplier: Multichemicals, RWP


White almost white colored
White almost white colored
1 Appearance
powder powder
Complies Soluble in water, sparingly

2 Solubility
soluble in ethanol
Complies Saccharin sodium must be
3 Identification
positive
4 M.P 229C 226C To 230C
5 LOD 15% NMT 15%
6 Assay 101.1% 99 To 102%
Sodium citrate
BP 2014
Sodium citrate ST1407076
Mfg .Date: JUL-2014 Supplier: Multi chemical Rwp
Exp. Date: JUL-2016 Receiving Date: 17-03-2015

White crystalline powder White or almost white

1 Appearance
crystalline powder
2 Solubility Complies Freely Soluble in water
Complies Sodium citrate must be
3 Identification
positive
4 LOD 11.1 11.0 To 13.0
7 Compressibility index 10.0% ≤10 Excellent
Citric Acid
BP 2014
Vol 1, Page # I-560
Citric acid AA-110530654
Status: Raw material Batch Size/Quantity: 10.488KG
Mfg .Date: Supplier: Aerochem Enterprises


1 Appearance White powder White to off white powder
2 Solubility Complies Freely soluble in water
3 Identification Complies Citric acid must be positive
4 LOD 7.9% 7.5% To 9%
5 Bulk density 0.76gm/ml 0.72gm/ml To o.8gm/ml
6 Tapped density 0.83gm/ml 0.8gm/ml To 0.86gm/ml
7 Sieve analysis 60 mesh 56% NLT 50% Passes
Sucrose
(Refined Sugar)
BP 2014
White Refined crystal sugar
Status: Raw material Batch Size/Quantity: 497.500kg
Mfg .Date: 12/2015 Supplier: I_9 chemical


1 Appearance Lustrous white powder Lustrous white powder
2 Solubility Complies Freely soluble in water
Complies White refined crystal Sugar
3 Identification
must be positive
4 LOD 0.1% NMT 0.1%
Dextrose
(In-house)
Dextrose Anhydrous A111801
Mfg .Date: 06-12-2014 Supplier: Multi chemical rwp

almost white crystalline
White or almost white,
1 Appearance
powder crystalline powder
Freely soluble in water,
2 Solubility Complies sparingly soluble in ethanol
(96%)
3 Identification Complies Dextrose must be positive
4 Water 0.12% Maximum 1.0%
5 Melting Point 146°C About 146 °C
6 PH 5.8 About 5.9 (10% solution)
Sorbitol powder
BP 2014
(BP 2014, Volume # 02, Page # II-886)
Sorbitol powder 20150110202
Mfg .Date: JAN-12-2015 Supplier: CD biochemistry/china
Exp. Date: JAN-11-2017 Receiving Date: 20-03-2015


1 Appearance White crystalline powder. White crystalline powder.
Complies Sorbitol powder must be
3 Identification
positive
4 PH 5.62 5.0 TO 7.0
5 Water 0.76% NMT 1.5%
6 Bulk density 0.6262g/ml 0.600g/ml to 0.650g/ml
7 Tapped density 0.652g/ml 0.640g/ml to 0.690g/ml
8 Compressibility index 3.95% ≤10 (Execellent)
Mannitol
BP 2014
Mannitol 20130909
Mfg .Date: 9-SEP-2013 Supplier: Multi chemical rwp/china
Exp. Date: 9-SEP-2015 Receiving Date: 10-03-2015


white color crystalline
white color crystalline
1 Appearance
powder powder

3 Identification Complies Mannitol must be positive
4 MP 170ºC 166ºC To 170ºC
5 LOD 0.4% NMT 0.5%
Methanol
BP 2014
Methanol
Status: Raw material Batch Size/Quantity: 200Litre
Mfg .Date: Supplier: City chemicals
Analysis Date: 11-09-2014 Q.C No: 094RM 0914


Clear, colorless volatile
1 Appearance Complies
liquid
Miscible with water and
alcohol
3 Refractive Index 1.330 1.328---1.330
4 Specific Gravity 0.792 0.791---0.793

Excipients Role + Specs + MOA + COA&#39;s

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Excipients Role + Specs + MOA + COA&#39;s

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Genome Pharmaceuticals (Pvt.) Ltd.

All of the excipients are conventional pharmaceutical ingredients comply with

S# Excipients Role of excipients Reference Supplier Name / Address

Used as a filler or diluent Foremost Farms Cooperativ,

(Avicel 102) BP 2014

S# Excipients Role of excipients Reference Supplier Name / Address

S# Excipients Role of excipients Reference Supplier Name / Address

S# Excipients Role of excipients Reference Supplier Name / Address

(PEG 6000) BP 2014

Organic solvent used as a wetting agent in BP 2014

Carboxymethylcellulose sodium Used as a suspending agent BP 2014

Used as a stabilizing agent BP 2014

S# Excipients Role of excipients Reference Supplier Name / Address

BP 2014 Mengzhou Huaxing Biochemical

Used as an acidifying agent, buffering BP 2014

S# Excipients Role of excipients Reference Supplier Name / Address

34 Hard Gelatin Capsule shell ------- In-house Gel Caps, Karachi

1 Appearance White Crystalline powder

2 Solubility soluble in water

6 Bulk Density 0.290 - 0.390g/ml

7 Tapped Density 0.390 - 0.54g/ml

1 Appearance Clear colourless Volatile liquid

2 Solubility Miscible with water

5 Water NMT 0.5%

6 Specific Gravity 0.785 – 0.789

5 Loss on drying: NMT 15 %

6 Iron: NMT 0.001%.

7 Residue on ignition NMT0.6%

8 Oxidizing substances: NMT0.002%

9 Sulfur dioxide: NMT0.005%

1 Appearance White powder

Freely but slowly soluble in water. Insoluble

4 Water / LOD 4.5% - 5.5%

NMT 0.4ml of 0.1N NaOH is required to

6 Bulk Density NMT 0.540 g /cm3

7 Tapped Density NMT 0.800 g /cm3

1 Appearance White Crystalline powder

Freely but slowly soluble in water. Insoluble

4 Water / LOD NMT 1%

NMT 0.4ml of 0.1N NaOH is required to

6 Bulk Density NMT 0.670 g / cm3

7 Tapped Density NMT 0.780 g / cm3

1 Appearance White crystalline powder

2 Solubility Insoluble in water

6 Bulk Density 0.290 - 0.320g/ml

7 Tapped Density 0.400 - 0.435g/ml

1 Appearance White fine free flowing powder

2 Solubility Gives Translucent Suspension in Water

5 LOD NMT 10%

6 Bulk Density 0.510 - 0.530g/ml

7 Tapped Density 0.800 - 0.830g/ml

1 Appearance White or grayish-white powder.

4 PH of 20% Suspension Between 4.0 and 7.0.

5 Loss on drying: NMT 10%

6 Water-soluble substances NMT 10.0 per cent.

7 Heavy metals Maximum 20 ppm.

8 Sulfated ash 14% to 28%

A cream colored odorless and tasteless, free-

2 Solubility Insoluble in water

Identification Kyron T-314

4 Loss on drying Not more than 10%

Alight ,fine, white or almost white

3 Identification Reactions of silicates must positive

Excipients Role + Specs + MOA + COA's

Excipients Role + Specs + MOA + COA's