Modelo: USP
Test Items |
Specification |
Test Results |
Description |
Yellow crystalline powder |
Yellow crystalline powder |
Completeness of solution |
2% of water solution for this product should clear |
Complies |
Identification |
Positive |
Positive |
Water |
7.0%-9.0% |
8.2% |
Residue on ignition |
0.2% |
0.05% |
Chromatographic purity |
0.5% |
0.5% |
Organic volatile impurities |
Alcohol 5000ppm |
337ppm |
(C20H22ClN3O·2HCl) Assay(C20H22ClN3O·2HCl) |
97.0%- |
99.8% |
Microbial limit |
Bacteria1000 CFU/g |
10 CFU/g |
Fungi100 CFU/g |
10 CFU/g |
|
Should not be detected |
Absent |
|
Conclusion |
The quality of the above commodity complies standard of USP31 and in house standard |
Grupo de Produto : Matérias primas farmacêuticas