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PRODUCT NAME: TOPIRAMATE USP32 EXPIRY DATE:3 years CAS NO.: |
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ITEM TESTED |
STANDARD |
RESULTS |
|
CHARACTERISTIC
|
WHITE OR NEAR WHITE CRYSTALLINE |
COMPLIES |
|
MELTING POINT
|
122℃-127℃ |
123.5℃-124.1℃ |
|
RESIDUE ON IGNITION
|
≤0.5% |
0.08% |
|
SPECIFIC ROTATION
|
-28°- 34° |
-31.60° |
|
LOSS ON DRYING
|
≤0.5% |
0.36% |
|
IDENTIFICATION |
IR COMPLIES HPCL COMPLIES |
COMPLIES COMPLIES |
|
CHLORIDES
|
≤0.015% |
≤0.011% |
|
RELATED SUBSTANCES |
SULPHATOD ASH≤0.1% LIMK OF SULFAMATE≤0.1% LIMK OF SULFATE≤0.1% |
0.05% COMPLIES COMPLIES |
|
HEAVY METALS
|
NMT≤10PPM |
COMPLIES |
|
SOLUBILITY
|
DIFFINENT DICHLOROMETHANC |
COMPLIES |
|
ASSAY
|
98.0%-102.0% |
99.2% |
|
CONCLUSION
|
QUALIFIED |
|
|
STORAGE
|
SEALED DARK RT=25±2℃，RH=60±5% |
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