CAS number： 96036-03-2
Molecular formula： C17H25N3O5S
molecular weight： 383.4625
Chemical structure：
| Product Name |
Meropenem with Sodium Carbonate |
||
| Shelf Life | 2 years | ||
ANALYSIS TEST |
SPECIFICATIONS |
RESULTS |
|
|
Appearance |
White to yellowish crystalline powder |
Conformed |
|
|
Identification |
positive |
Conformed |
|
| PH | 7.3~8.3 | 7.9 | |
| Loss on drying | 9.0%~12.0% | 10.1% | |
| Colour of solution | ≤Y5# orK5# of reference solution | ＜K1# | |
| Clarity of solution | ≤05# of reference suspension | ＜0.5# | |
| Visible matter | Comply with the requirement | complies | |
| Limit of Acetone | ≤0.05% | 0.01% | |
| Bulk density | Informative | 043g/cm3 | |
|
Related substance On dry basis |
PRT(0.45) | ≤0.80% | 0.02% |
| PRT(1.90) | ≤0.60% | ND | |
| Particulate Matter | ≥10um | ≤4000 per container | 126 per container |
| ≥25um | ≤400 per container | 0 per container | |
| Uniformity of dosage units | Meets the requirements | Conformed | |
| Bacterial endotoxinsunder | ≤0.125EU/mg | Conformed | |
| Sterility | Meets the requirements | Conformed | |
|
Assay(C17H25N3O5S) on anhydrous basis |
≥78.0% | 82.3% | |