Item
Standard
Results
Appearance
White
to yellowish-white powder
Conforms
Identification
Test
A(TLC): Conforms
Conforms
Test B(Color reaction): Conforms
Conforms
Test C(Sulfate): Conforms
Conforms
Assay(Dried Substance)
≥600 I.U. /mg
652
Loss on drying
≤8.0%
4.1
Ph
5.0-7.5
6.7
Conclusion
The batch complies with the specification of
USP43