|
Test Items
|
Specification
|
Test Results
|
|
Appearance
|
White or off-white powder
|
white powder
|
|
Identification
|
UV conform
|
Conforms
|
|
Organic nitrogenous
|
Conforms
|
Conforms
|
|
Citrate
|
Conforms
|
Conforms
|
|
Water
|
Not more than 1.0%
|
0.38%
|
|
Heavy water
|
Not more than 0.002%
|
Conforms
|
|
Related impuries
|
Related compound A:Not more than 2.0%
|
0.86%
|
|
Individual:Not more than 0.5%
|
0.38%
|
|
(Z)isomer
|
Conforms
|
Conforms
|
|
Organicvolatile impuritise
|
Conforms
|
Conforms
|
|
Assay
|
Between98.0~102.0%
|
99.2%
|
|
Conclusion
|
This batch is complies with USP 32.
|
