BioPlus Life Sciences Pvt Ltd. - Glucosamine Hydrochloride

Identification & Functionality

Ingredient Name: Glucosamine Sulfate HCl
Food Ingredients Functions: Supplement
Pharma & Nutraceuticals Functions: Supplement
Technologies: Food Ingredients,
Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Nutraceuticals & Supplements
Supplements & Functional Ingredients
Food Ingredients — Nutrition & Fortification
Functional Ingredients

Features & Benefits

Properties

Physical Form: Crystals,
Powder,
Solid
Appearance: White or almost white crystalline powder
Taste: Slightly sweet
Insoluble in: Acetone
Slightly Soluble in: Methanol
Soluble in: Water
Typical Properties
Microbiological Values
Impurities
Sieve Test
Identification: Specification Limits Method

Test A (Infra red absorption) The IR spectrum of test sample should corresponds
to the IR spectrum of the reference standard
USP-NF / Ph. Eur*

Test B (Chloride) It meets the requirements of the test for chloride.
USP-NF / Ph. Eur*

Test C (HPLC) The retention time of the glucosamine peak of the sample
solution corresponds to that of the standard solution, as
obtained in the assay. USP-NF*
Note: * - USP 43 - NF38, INH – Inhouse, Ph. Eur.-10.4

	Value	Units	Test Method / Conditions
Appearance of Solution	Clear and colourless	—	Ph. Eur.*
Assay (on dried basis)	98.0 - 102	%	USP-NF/Ph. Eur*
Chloride and Sulfate	max. 0.24	%	USP-NF/Ph. Eur*
Degree of Browning Test	max. 0.02	AU	INH
Filtration Test	Passes	—	INH
Heavy Metals	max. 10	ppm	USP-NF*
Loss on Drying	max. 1.0	%	USP-NF/Ph. Eur*
Opacity Test	max. 0.01	AU	INH
Organic Volatile Impurity (Methanol)	max. 3000	ppm	USP-NF/Ph. Eur*
pH	3.0 - 5.0	—	USP-NF/Ph. Eur*
Residue on Ignition	max. 0.10	%	USP-NF/Ph. Eur*
Specific Optical Rotation	70.0 - 74.0	degree	USP-NF/Ph. Eur*

	Value	Units	Test Method / Conditions
Bile Tolerant Gram Negative Bacteria	10.0	cfu/g	USP-NF/Ph. Eur*
Escherichia coli	Absent	/g	USP-NF/Ph. Eur*
Salmonella	Absent	/10g	USP-NF/Ph. Eur*
Staphylococcus aureus	Absent	/g	USP-NF/Ph. Eur*
Total Aerobic Microbial Count	max. 10	cfu/g	USP-NF/Ph. Eur*
Total Combined Yeast/Mould Count	max. 10	cfu/g	USP-NF/Ph. Eur*

	Value	Units	Test Method / Conditions
Sieve Test (Passing through 40 mesh)	100.0	%	USP-NF*

Regulatory & Compliance

Certifications & Compliance: BRC Certified,
European Pharmacopeia (Ph. Eur.),
GMP,
Halal,
ISO 9001,
National Formulary (NF),
United States Pharmacopeia (USP)

Packaging & Availability

Storage & Handling

Shelf Life: 3 Years
Storage Condition: Product is to be stored in cool, dry place. Avoid direct expose to sunlight.

BioPlus Life Sciences Pvt Ltd. Glucosamine Hydrochloride

Specification	Limits	Method
Test A (Infra red absorption)	The IR spectrum of test sample should corresponds to the IR spectrum of the reference standard	USP-NF / Ph. Eur*
Test B (Chloride)	It meets the requirements of the test for chloride.	USP-NF / Ph. Eur*
Test C (HPLC)	The retention time of the glucosamine peak of the sample solution corresponds to that of the standard solution, as obtained in the assay.	USP-NF*