Standard: 99% MIN (2:1)
Package: 5kg/tin
Standard: 99% MIN (2:1)
Package: 5kg/tin
ITEMS | LIMIT |
Characters | White or almost white powder or crystalline powder |
Identification | Positive |
Color of Solution | Y or GY |
Clarity of Solution | Clear, Colorless or |
Water | ≤1.5% |
PH | 8.0~10.0 |
Uniformity of Content | ±1.5% |
Ampicillin Assay | ≥57.3% on the anhydrous basis |
Sulbactam Assay | ≥29.0% (on the anhydrous basis) |
Bacterial Endotoxins | |
Related Substances | Any peak≤1.0% |
The sum≤2.0% | |
Bulk Density | ≥0.30g/ml |
Tapped density | ≥0.50g/ml |
Sterility | Complies |