|
Item
|
Specification
|
Method
|
|
Appearance
|
A white or yellow-white powder
|
|
|
Identification
|
Complies
|
EP
|
|
Appearance of solution
|
Clear
|
EP
|
|
pH
|
4.5 - 7.5
|
EP
|
|
Loss on drying
|
Less than 5.0%
|
EP
|
|
Bacterial endotoxins
|
Less than 0.2 IU per IU of hyaluronidase
|
EP
|
|
Limit of tyrosine
|
Less than 0.25 µg per USP Hyaluronidase U.
|
USP
|
|
Activity
|
More than 300 IU/mg powder
|
EP
|
Conclusion: Product complies with USP and EP.
Storage
Store in an airtight container, at a temperature of 2°Cto 8°C.
