Grade: Pharmaceutical Grade
Factory Location: Xiamen, Fujian
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East
Monthly Production Capacity: 1000kg
Packaging Information: 25kg/drum 1kg/bottle
Delivery Lead Time: 7 days after payment
Sample Provided: yes
Payment Terms: L/L
Product Information |
Product name |
Irbesartan |
CAS No. |
138402-11-6 |
Molecular Formula |
C25H28N6O |
Molecular Weight |
428.53 |
Quality Standard |
98% up, USP/ EP |
Appearance |
White to almost white powder |
COA of Irbesartan |
ITEMS |
STANDARDS |
RESULTS |
Appearance |
White to off-white powder |
White 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 |
NMT10ppm |
Not detected |
Heavy metals |
NMT0.002% |
Conforms |
Related compounds(HPLC) |
Compound A NMT0.2% |
0.01% |
Any other impurity NMT0.1% |
0.04% |
|
Total impurity NMT0.5% |
0.09 |
|
Residual solvents(GC) |
Ethanol NMT 5000ppm |
2307 ppm |
Toluene NMT 890ppm |
238 ppm |
|
Dichloromethane NMT3000 ppm |
Not detected |
|
N,N-Dimethylformamide NMT880 ppm |
Not detected |
|
T-butyl Methyl Ether NMT 5000 ppm |
Not detected |
|
Assay |
98.0—102.0% |
99.2% |
Conclusion |
The analysis results show that this batch of irbesartan conforms to USP |
Usage |