Product Name | CEFTAZIDIME PENTAHYDRATE AND SODIUM CARBONATE | |
Shelf Life | 2 years | |
TEST ITEMS | SPECIFICATION | RESULT |
Description | White or almost white crystalline powder. | Complies |
Identification | Meets the requirements | Complies |
pH | 5.0~7.5 | 6.8 |
Loss on drying | ≤13.5% | 13.2% |
Limit of pyridine | ≤0.4% | 0.0% |
Sodium carbonate Assay | Informative | 9.8% |
Particulate Matter | ≤600particles(≥25μm) | Particl(s):3 |
Bacterial endotoxins |
0.1EU/mg Less than 0.1 EU/mg Not more than 0.1 USP Endotoxin Unit per mg of ceftazidime |
Complies |
Assay | 90.0 per cent to 105.0 per cent (dried and carbonate-free substance). | 100.3% |
Sterility | Meets the requirements | Complies |
RESULT: THE RESULT CONFORMS TO USP37. |