Candesartan Cilexetil
Common Name of Material |
Candesartan Cilexetil |
Batch No. |
20041023 |
Quantity |
15 kgs |
Packing |
|
Manufacturing Date |
Oct.-23-2004 |
Basis of Quality Standard |
Enterprise Standard |
Expiry Date |
Oct.-23-2007 |
| Analysis Items |
Specification Limits |
Analysis Results |
| Appearance |
white crystal |
qualified |
| Solubility |
very soluble in chloroform. slightly soluble in methanol . Insoluble in water, |
qualified |
Identification |
|
-IR |
similar to standard |
qualified |
|
-UV |
similar to standard max.at 210.253.304nm |
qualified |
| Loss on Drying |
¡Ü 1.5% |
0.4% |
| Residue on Ignition |
¡Ü 0.1% |
0.09% |
| Heavy Metals |
¡Ü 20ppm |
qualified |
| Related Impurities(HPLC) |
total impurities ¡Ü 1.0% |
0.24% |
|
individual impurity ¡Ü 0.5% |
0.13% |
| Assay |
98.0-102.0% |
99.56% |
Conclusion:It complies with all the requirements of the Enterprise Standard.
Director: Liuanhua Reviser:Wangshumei Inspector: Chenying |
