IRBESARTAN
BATCH NO.: 20041002
QUANTITY: 50kg
MANUF DATE: 2004/10/02
EXPIRY DATE: 2007/10/02
DESCRIPTION: A white powder odourless free from strange matter
Test Items Sdandard Result
| TEST |
STANDARD |
RESULT |
| Solubility |
Very soluble in dimethylformanide sparingly soluble in methanol.slightly soluble in ethanol. insoluble in water |
qualified |
| Identification: |
|
|
|
Reaction with copper sulfate |
positive |
positive |
|
HPLC |
similar to standard |
qualified |
|
UV |
similar to standard |
qualified |
| Residue on ignition |
¡Ü 0.1% |
0.1% |
| Loss On drying: |
¡Ü 5% |
0.4% |
| Residue On Ignition: |
¡Ü 0.1% |
0.1% |
| Chlorides |
¡Ü 0.1% |
qualified |
| Heavy Metals: |
¡Ü 20ppm |
qualified |
| Relative impurities |
Total impurities ¡Ü 1.0% |
0.31% |
|
individual impurity ¡Ü 0.5% |
0.29% |
| Residual Solvents |
dichloromethane ¡Ü 0.06% |
qualified |
|
xylene(mixture) ¡Ü 0.217% |
qualified |
| Assay (On Dry Basis): |
98.0-101.0% of irbesartan |
|
|
calculated on dried basic |
99.81% |
This is certified that we, the undersigned, have inspected the quality of above-mentioned goods and found the result as following:
CONCLUSION: CONFORM TO ENTERPRISE STANDARD
Approved by: WangRuZhou Tested by: ZhouShuHai |
