CERTIFICATE OF ANALYSIS
NAME GANCICLOVIR
|
MANU DATE |
2001-05-10 |
ANALYSIS DATE |
2001-05-12 |
|
QUANTITY |
3KG |
QUALITY STANDARD |
FACTORY STANDARD |
|
ITEMS |
STANDARD |
RESULTS |
|
CHARACTORS |
WHITE CRYSTALLINE POWDER |
COMPLIES |
|
IDENTIFICATION |
CONFORM TO THE TEST UITRAVIOLET ABSORPTION INFRARED ABSORPTION |
CONFORM TO THE TEST COMPLIES COMPLIES |
|
CLARITY AND COLOUR OF SOLUTION |
CLEAR AND COLOURLESS |
COMPLIES |
|
INSOLUBLE,IMPURITIES |
96%MIN |
96.5% |
|
RELATED SUBSTANCES |
1.0%MAX |
0.42% |
|
LIMIT FOR GUANINE |
0.7%MAX |
0.23% |
|
LOSS ON DRYING |
5.0%MAX |
1.60% |
|
RESIDE ON IGNITION |
0.1%MAX |
0.04% |
|
HEAVY METALS |
10PPM |
COMPLIES |
|
ASSAY |
98%MIN |
99.12% |