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BioPlus Life Sciences Pvt Ltd. Glucosamine Sulfate Sodium Chloride

Glucosamine is an amino mono-saccharide and a natural constituent of glycosaminoglycans in articular cartilage matrix and synovial fluid. It is the most fundamental building block required for synthesis of cartilage matrix and synovial fluid. Glucosamine contributes to the resilience or shock absorbing capacity of the cartilage.

Ingredient Name: Glucosamine Sulfate NaCl

Animal Species: Pets

Labeling Claims: Halal, Kosher

Certifications & Compliance: BRC Certified, European Pharmacopeia (Ph. Eur.), GMP, Halal, ISO 14001, ISO 22000, ISO 9001, Kosher, NSF Approved, National Formulary (NF), SEDEX Approved, United States Pharmacopeia (USP)

Benefit Claims (Health): Anti-Inflammatory, Antioxidant Properties, Cartilage Regeneration, Joint Support, Pain Reduction

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Knowde Enhanced TDS

Identification & Functionality

Animal Feed & Nutrition Functions
Food Ingredients Functions
Pharma & Nutraceuticals Functions

Features & Benefits

Labeling Claims
Animal Feed & Nutrition Features
Benefits
  • Improves signs & symptoms - joint function, flexibility & pain
  • Has chondroprotective action, delays further tear of the damaged cartilage
  • Restricts the disease progression
  • Has anti-inflammatory action
  • Has antioxidant potential

Applications & Uses

Animal Species
Dosage Form

Properties

Appearance
White or almost white crystalline powder
Insoluble in
Acetone
Slightly Soluble in
Methanol
Soluble in
Water
Typical Properties
ValueUnitsTest Method / Conditions
Appearance of SolutionClear and colourlessPh. Eur.*
Assay (on dried basis)98.0 - 102.0%USP-NF/Ph. Eur*, HPLC
Chloride11.0 - 13.0%INH
Sulfate Content16.3 - 17.3%USP-NF*
Heavy Metalsmax. 10ppmUSP-NF*
Iron Contentmax. 10ppmPh.Eur.2.4.9
Loss on Dryingmax. 1.0%USP-NF/Ph. Eur*
Organic Volatile Impurities (Methanol)max. 1000ppmUSP-NF*
pH3.0 - 5.0USP-NF/Ph. Eur*
Residue on Ignition22.5 - 26.0%USP-NF/Ph. Eur*
Specific Optical Rotation50.0 - 55.0degreeUSP-NF/Ph. Eur*
Specified Impuritiesmax. 0.10%Ph. Eur.*
Water Contentmax. 1.5%Ph.Eur.2.5.12
Microbiological Values
ValueUnitsTest Method / Conditions
Bile Tolerant Gram Negative Bacteria10.0cfu/gUSP-NF/Ph. Eur*
Escherichia coliAbsent/gUSP-NF/Ph. Eur*
SalmonellaAbsent/10gUSP-NF/Ph. Eur*
Staphylococcus aureusAbsent/gUSP-NF/Ph. Eur*
Total Aerobic Microbial Countmax. 10cfu/gUSP-NF/Ph. Eur*
Total Combined Yeast/Mould Countmax. 10cfu/gUSP-NF/Ph. Eur*
Impurities
ValueUnitsTest Method / Conditions
Arsenic Contentmax. 3μg/gUSP-NF*
Mercurymax. 1ppmExternal analysis
Total Impuritiesmax. 0.10%Ph. Eur.*
Sieve Test
ValueUnitsTest Method / Conditions
Sieve Test (Passing through 80 mesh)PassesUSP-NF*
Identification
Specification Limits Method
Test A (Infra red absorption) The IR spectrum of sample matches with glucosamine hydrochloride standard.

USP-NF / Ph. Eur*

Test B (Chloride & Sodium) It meets the requirements of the tests for chloride and sodium.

USP-NF / Ph. Eur*

Test C (Glucosamine) 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*
Test D (Sulfate) It meets the requirement of the test for sulfate.

USP-NF / Ph. Eur*

 

Note

* - USP 43 - NF38, INH – Inhouse, Ph.Eur-10.4
# - This tests will be performed at external lab

Regulatory & Compliance

Packaging & Availability

Packaging Type
Packaging

In double LDPE liner bags packed in HDPE drums/shippers.

Storage & Handling

Shelf Life
3 Years
Storage Condition

Product is to be stored in cool, dry place. Avoid direct exposure to sunlight.