HOMAP

Health & OTC Manufacturing Associates Pakistan

Mailing Address: House No. 1-D, Block C, Haq Bahoo Street, Judicial Colony, Canal Bank Road, Lahore
homap.association@gmail.com +92-321-6400352 [Convenor Adhoc Committee]

March 18, 2020

The
CEO
Drug Regulatory Authority of Pakistan
Islamabad

Respected Sir,

ISSUANCE OF PENDING FORM-7 OF Dextrose Anhydrous PERTAINING TO COMMON MOLECULES

DEALT BY H & OTC AND PE&R DIVISIONS

We are manufacturers of quality H & OTC products with approvals under Form-7, for local and international
markets.

Quite a number of applications of our associates are pending for approvals in H & OTC Division for the molecules
present in common molecule list. One of them is Dextrose Anhydrous.

The H & OTC Division had already issued Form-7 of Dextrose Anhydrous to a number of H & OTC Manufacturers.
All the manufacturers holding Form-6 have a fundamental right to be treated as par without any differentiation
for issuance of Form-7. It is worth mentioning here that this molecule is also used by manufacturers of
nutraceuticals / herbals in Europe, Australia, USA, Japan, China, India etc. These molecules are dietary
supplements used in H & OTC and consumer products.

We earnestly request you to kindly issue instructions to H & OTC Division for approval of pending Form-7 for
Dextrose Anhydrous molecule present in the common molecules list.

Thanking you,

Yours sincerely,

Ehsan-ul-Haq
Convenor Adhoc Committee HOMAP
 Generic Name
of
Dextrose Anhydrous

Generic Name of Dextrose Anhydrous is Dextrose.

Dextrose Anhydrous
(USP Reference in Dietary Supplement Chapter)

Dextrose ■.•
C. WATER DETERMINATION 〈921〉 Sample Add the following: Anhydrous: 0.50 g Monohydrate:
0.25 g ■.Portions of this monograph that are national USP text, and Acceptance criteria are not part of
the harmonized text, are marked with Anhydrous: NMT 1.0% symbols (◆ Monohydrate: 7.5%–
9.5%■2S (USP39) . ◆) to specify this fact.■2S (USP39)
ASSAY Change to read: Add the following: ■.• PROCEDURE Mobile phase: Water System suitability
solution: Dissolve 5 mg of USP Maltose Monohydrate RS, 5 mg of USP Maltotriose RS, and 5 mg of
USP Fructose RS in water and dilute with water to 50.0 mL. C6H12O6 · H2O 198.17 Standard solution
A: 30 mg/mL of USP Dextrose RS C Sample solution: 30 mg/mL, determined on the anhy- 6H12O6
180.16 drous basis D-Glucose monohydrate ■.[77938-63-7].■2S (USP39) Anhydrous [50-99-7].
Chromatographic system (See Chromatography 〈621〉, System Suitability.)
DEFINITION Mode: LC Detector: Refractive index Column: 7.8-mm × 30-cm; 9-µm packing L191.
Change to read: Temperatures Detector: 40° ■.Dextrose is (+)-D-glucopyranose and is derived from
Column: 85 ± 1° starch. It contains one molecule of water of hydration or Flow rate: 0.3 mL/min is
anhydrous. It contains NLT 97.5% and NMT 102.0%, Injection volume: 20 µL calculated on the
anhydrous basis.■2S (USP39) Run time: 1.5 times the retention time of dextrose System suitability
IDENTIFICATION Sample: System suitability solution [NOTE—The relative retention times for
maltotriose, Delete the following: maltose, isomaltose, dextrose, and fructose are 0.7, 0.8, 0.8, 1.0, and
1.3, respectively. The retention time ■ for dextrose is about 21 min.] .• A. Sample solution: Suitability
requirements 1 in 20
Analysis: Add a few drops of the Sample solution to Resolution: NLT 1.3 between maltotriose and 5
mL of hot alkaline cupric tartrate TS. maltose Acceptance criteria: Analysis A copious red precipitate of
cuprous oxide is formed. Samples: Standard solution A and Sample solution ■2S (USP39) Calculate the
percentage, on the anhydrous basis, of dextrose (C6H12O6) in the portion of Dextrose taken: Add the
following: Result = (rU/rS) × (CS/CU) × 100 ■.• ◆.A. INFRARED ABSORPTION 〈197〉◆. ■2S
(USP39) rU = peak response of dextrose from the Sample solution Add the following: rS = peak
response of dextrose from Standard solution A ■.• B. CS = concentration of USP Dextrose RS in
Standard Analysis: Examine the chromatograms obtained in the solution A (mg/mL) Assay. CU =
concentration of the Sample solution, based on Acceptance criteria: The principal peak obtained with the
anhydrous basis (mg/mL) the Sample solution is similar in retention time and size Acceptance criteria:
97.5%–102.0% on the anhydrous to the principal peak obtained with Standard solution A. basis■2S
(USP39) ■2S (USP39)
IMPURITIES Add the following: ■.• RELATED SUBSTANCES Mobile phase, System suitability
solution, Standard solution A, and Chromatographic system: Proceed as directed in the Assay. 1
.Aminex HPX-87C from Biorad is suitable. 2015 The United States Pharmacopeial Convention All
Rights Reserved. Stage 6 Harmonization 2 Dextrose Official December 1, 2016 Standard solution B:
Dilute 1.0 mL of the Sample solu- Acceptance criteria: NMT 5 µg/g◆. • (Official 1-Jan-2018) tion with
water to 250.0 mL. Standard solution C: Dilute 25.0 mL of Standard solu- SPECIFIC TESTS tion B
with water to 200.0 mL. Sample solution: 30 mg/mL, determined on the anhy- Add the following: drous
basis System suitability ■.•
COLOR AND CLARITY OF SOLUTION Sample: System suitability solution Reference solution:
To 2.5 mL of cobaltous chloride [NOTE—The relative retention times for maltotriose, CS, 6.0 mL of
ferric chloride CS, and 1.0 mL of cupric maltose, isomaltose, dextrose, and fructose are 0.7, sulfate CS
add hydrochloric acid [10 g/L of hydrogen 0.8, 0.8, 1.0, and 1.3, respectively. The retention time
chloride (HCl)] to make 1000.0 mL. for dextrose is about 21 min.] Hydrazine sulfate solution: Dissolve
1.0 g of hydra- Suitability requirements zine sulfate in water and dilute to 100.0 mL. Allow to
Resolution: NLT 1.3 between maltotriose and stand for 4–6 h. maltose Hexamethylenetetramine
solution: In a 100-mL Analysis ground-glass-stoppered flask, dissolve 2.5 g of hexa- Samples: Standard
solution A, Standard solution B, methylenetetramine in 25.0 mL of water. Standard solution C, and
Sample solution Primary opalescent suspension: To the Hexamethyl- Disregard any peak with an area
less than the principal enetetramine solution in the flask add 25.0 mL of the peak obtained with Standard
solution C (0.05%). Hydrazine sulfate solution. Mix and allow to stand for Acceptance criteria 24 h.
This suspension is stable for 2 months, provided Maltose and isomaltose: NMT 0.4%. The sum is it is
stored in a glass container free from surface de- NMT the area of the principal peak obtained with fects.
The suspension must not adhere to the glass and Standard solution B. must be well mixed before use.
Maltotriose: NMT 0.2%. NMT 0.5 times the area of Standard of opalescence: Dilute 15.0 mL of the Pri-
the principal peak obtained with Standard solution B. mary opalescent suspension with water to 1000.0
mL. Fructose: NMT 0.15%. NMT 3 times the area of the This suspension is freshly prepared and may be
stored principal peak obtained with Standard solution C. for up to 24 h. Unspecified: NMT 0.10%. NMT
twice the area of the Reference suspension: To 5.0 mL of Standard of opal- principal peak obtained with
Standard solution C. escence add 95.0 mL of water. Mix and shake before Total impurities: NMT 0.5%.
NMT 1.25 times the use. area of the principal peak obtained with Standard so- Sample solution:
Dissolve 10.0 g in 15 mL of water lution B.■2S (USP39) using a bath of boiling water. Allow to cool.
Analysis: Make the comparison by viewing the soluDelete the following: tions downward in matched
color-comparison tubes against a white surface (see Spectrophotometry and ■ Light-Scattering 〈851〉,
Visual Comparison). .• RESIDUE ON IGNITION 〈281〉: NMT 0.1%■2S (USP39) Acceptance criteria:
The Sample solution is clear (its clarity is the same as that of water or its opalescence is Delete the
following: not more pronounced than that of the Reference suspension) and not more intensely colored
than the Refer- ■.• CHLORIDE AND SULFATE 〈221〉, Chloride ence solution.■2S (USP39) Control:
0.50 mL of 0.020 N hydrochloric acid Sample: 2.0 g Acceptance criteria: Delete the following: 0.018%;
the Sample shows no more chloride than the Control.■2S (USP39) ■.• COLOR OF SOLUTION
Control: Mix 1.0 mL of cobaltous chloride CS, 3.0 mL Delete the following: of ferric chloride CS, and
2.0 mL of cupric sulfate CS with water to make 10 mL, and dilute 3 mL of this so- ■.• CHLORIDE
AND SULFATE 〈221〉, Sulfate lution with water to 50 mL. Control: 0.50 mL of 0.020 N sulfuric acid
Sample solution: 25 g of Dextrose in water to make Sample: 2.0 g 50.0 mL Acceptance criteria: 0.025%;
the Sample shows no Analysis: Make the comparison by viewing the solu- more sulfate than the
Control.■2S (USP39) tions downward in matched color-comparison tubes against a white surface.
Acceptance criteria: The Sample solution has no more Delete the following: color than the Control.■2S
(USP39) ■.• ARSENIC 〈211〉, Method I: NMT 1 µg/g■2S (USP39) Delete the following: Delete the
following: ■.• ACIDITY • Sample solution: Dissolve 5.0 g in 50 mL of carbon di- .• ◆.HEAVY
METALS 〈231〉 oxide-free water. Add phenolphthalein TS. Test preparation: 4.0 g of Dextrose in water
to make Analysis: Titrate with 0.020 N sodium hydroxide to 25 mL the production of a distinct pink
color. 2015 The United States Pharmacopeial Convention All Rights Reserved. Stage 6 Harmonization
Official December 1, 2016 Dextrose 3 Acceptance criteria: NMT 0.30 mL■2S (USP39) Analysis: To the
Sample solution add 25 µL of iodine TS. Acceptance criteria: The resulting solution is yellow Delete the
following: (NMT 15 ppm).■2S (USP39) ■.• WATER DETERMINATION 〈921〉, Method III
ADDITIONAL REQUIREMENTS Analysis: Dry at 105° for 16 h. Acceptance criteria Hydrous form:
Change to read: 7.5%–9.5% Anhydrous form: NMT 0.5%■2S (USP39) • ■. ◆. ■2S
(USP39)PACKAGING AND STORAGE: Preserve in wellclosed containers.■. ◆. ■2S (USP39) Delete
the following: ■ Change to read: .• OPTICAL ROTATION 〈781S〉, Specific Rotation Sample solution:
100 mg/mL of Dextrose in 0.012 N • ■. ◆ ammonium hydroxide . ■2S (USP39)LABELING: Label to
indicate whether it is hydrous or anhydrous.■. ◆ Acceptance criteria: +52.6° to +53.2°■ . ■2S (USP39)
2S (USP39) Add the following: Add the following: ■.• ◆ ■ .
USP REFERENCE STANDARDS 〈11〉 .• CONDUCTIVITY Sample solution: Dissolve 20.0 g in
carbon dioxide- USP Dextrose RS free water prepared from distilled water and dilute USP Fructose RS
with the same solvent to 100.0 mL. USP Maltose Monohydrate RS Analysis: Measure the conductivity
of the solution USP Maltotriose RS◆ while gently stirring with a magnetic stirrer. ■2S (USP39)
Acceptance criteria: NMT 20 µS/cm at 25°■2S (USP39) • DEXTRIN Sample: 1 g, finely powdered
Analysis: Reflux the Sample with 20 mL of alcohol. Acceptance criteria: The Sample dissolves
completely. Change to read: • SOLUBLE STARCH, SULFITES ■.Sample solution: Dissolve the
Dextrose sample (6.7 g of anhydrous or 7.4 g of monohydrate) in 15 mL of water using a bath of boiling
water. Allow to cool.

International References

Of

Reference 1: Dextrose anhydrous

As OTC Product
ORSNEED POWDER(ORAL REHYDRATION SUPPLEMENTS STRAWBERRY FLAVOUR)
Manufactured BY

Westcoast Pharmaceutical Works Limited's Corporate Identification Number is (CIN)

U24233GJ2007PLC050504 and its registration number is 50504. Its
Email address is accounts@westcoastin.com and its registered address is F.P. No.
17 & 16/5 Meldi Estate, Nr.

Product Description
Product Class
OTC Preparation

Oral
Electrolytes Mixture
With Probiotic Blend & Zinc

ORSNEED POWDER(ORAL REHYDRATION SUPPLEMENTS STRAWBERRY FLAVOUR)

Each Sachet of 7.9gm Contains:
Anhydrous Dextrose 2.8gm
Sodium Chloride 0.52gm
Potassium Chloride 0.3gm
Sodium Citrate 0.58gm
Streptococcus Faecalis 30 million
Clostridium Butyricum 2 million
Bacillus Mesentericus 1 million
Lactic Acid Bacillus 50 million
Fructo Oligo Saccharide 25 mg
Zinc Sulphate 5 mg
Reference 2.

Produc Name

Energy Boost with vitamin C

Product Class

OTC Dietary Supplement

Manufactured By

Nutricore Biosciences Private Limited, Gujrat India.

Product Description

Black Currant Flavor Energy Drink Powder 1 Kg 

 Complex Carbohydrates Mix with Minerals
 Electrolytes & Vitamin C
Health Oxide Energy Boost is a healthy energy drink that takes you a level up and
keeps you healthy. Healthoxide Energy Boost is a high performance energy drink
including all major electrolytes(potassium, magnesium, chloride and sodium) that
conduct electricity in the body and helps in maintaining the acid base balance in the
body.
  Direction to Use
 Mix one level scoop (30 g) in 200-250 ml cold water and stir until dissolved.
 It can also be mixed with juices, creatine or other food and dietary
supplements for additional benefits.
Consume before, during and after workout to restore your energy.
Ingredients

 
 
Black Currant Green Apple

Dextrose Monohydrate, Dextrose Monohydrate, Sucrose, Citric Acid,

Sucrose, Citric Acid, Ascorbic
Acid, Vitamins & Minerals,
Taurine, Inositol, Permitted
Colour, Flavour &
Preservatives.
Ascorbic Acid, Vitamins & Minerals, Taurine,
Inositol, Permitted Colour, Flavour &
Preservatives.

Guava Pineapple

Dextrose Monohydrate, Dextrose Monohydrate, Sucrose, Citric Acid,

Sucrose, Citric Acid, Ascorbic
Acid, Vitamins & Minerals,
Taurine, Inositol, Permitted
Colour, Flavour &
Preservatives.
Ascorbic Acid, Vitamins & Minerals, Taurine,
Inositol, Permitted Colour, Flavour &
Preservatives.

Orange

Dextrose Monohydrate, Sucrose, Citric Acid, Ascorbic Acid, Vitamins &

Minerals, Taurine, Inositol, Permitted Colour, Flavour & Preservatives.
Reference 3.

Product Name

Wings Oral Rehydrate Therapy

Product Class
OTC Preparation

Manufactured By

Wings Biotech, India