IRBESARTAN
Basic information ofIrbesartan
Name |
Irbesartan |
Molecular Formula |
C25H28N6O |
Molecular Weight |
428.53 |
QualityStandard |
EP/USP |
Package Size |
25kg/drum |
Brief Introduction |
Irbesartan is an angiotensin II receptor antagonist used mainly for |
Usage of Irbesartan
- Mainly used for treatment of high blood pressure.
COA ofIrbesartan
ITEMS |
SPECIFICATION |
RESULTS |
APPEARANCE |
WHITE TO OFF-WHITE,CRYSTALLINE POWDER |
WHITE CRYSTALLINE POWDER |
IDENTIFICATION |
INFRARED ABSORPTION:THE IR SPECTRUM IS CONSISTENT WITH THAT OBTAINED WITH THE REFERENCE |
CONFORMS |
THE RETENTION TIME OF THE MAJOR PEAK IN THE CHROMATOGRAM OF THE ASSAY PREPARATION CORRESPONDS TO THAT IN THE CHROMATOGRAM OF THE STANDARD PREPARATION,AS OBTAINED IN THE ASSAY |
CONFORMS |
|
WATER |
NMT 0.5% |
0.24% |
LIMIT OR AZIDE |
NMT 10PPM |
NOT DETECTED |
HEAVY METALS |
NMT 0.002% |
CONFORMS |
RELATED COMPOUNDS |
COMPOUND A NMT 0.2% |
0.01% |
ANY OTHER IMPURITY NMT 0.1% |
0.04% |
|
TOTAL IMPURITIES NMT 0.5% |
0.09% |
|
RESIDUAL SOLVENTS(GC) |
ETHANOL NMT 5000PPM |
2307PPM |
TOLUENE NMT 890PPM |
238PPM |
|
DICHLOROMETHANE NMT 600PPM |
NOT DETECTED |
|
N,N-DIMETHYLFORMAMIDE NMT 880PPM |
NOT DETECTED |
|
T-BUTYL METHYL ETHER NMT 5000PPM |
NOT DETECTED |
|
ASSAY(ON THE ANHYDROUS BASIS) |
98.0%~102.0% |
99.1% |
CONCLUSION:THE ANALYSTS RESULTS SHOW THAT THIS BATCH OF IRBESARTAN CONFORMS TO USP |
- Sinoway Industrial Co., Ltd.
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