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DESCRIPTION
Hyaluronidase is a glycoprotein containing 5% mannose and 2.7% glucosamine. Optimum pH range is 4.5-6.0. The enzyme catalyzes the hydrolysis of endo-N-acetylhexosaminic bonds of hyaluronic acid and chondroitin sulfate A and C (but not B), primarily to tetrasaccharide residues.
Linzyme Hyaluronidase is extracted from bovine testes, and has been chromatographically purified to remove trace contaminating proteases.
SPECIFICATION
Item
Specification
Method
[Appearance]
A white or yellowis-white powder
[Identification]
Complies
EP
pH
4.5 – 7.5
EP
Appearance of solution
Clear
EP
Loss on drying
≤ 5.0%
EP
Bacterial endotoxins
Less than 0.2 IU per IU of hyaluronidase
EP
Limit of tyrosine
≤ 0.25 μg per USP Hyaluronidase U.
USP
Activity
≥ 300 IU/mg powder
EP
Conclusion: Product complies with USP and EP.
STORAGE
Store in an airtight container, at a temperature of 2°C to 8°C, or below.
Fourteen years of qualification
Audited Supplier
Pharma Sources Insight January 2025
