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CAS 96036-03-2 Meropenem C17H25N3O5S
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Introduction:
Meropenem is a new carbapenem antibiotic introduced to market for the i.v. treatment of a wide variety of hospital infections such as lower respiratory tract, urinary tract, intraabdominal, gynecological and polymicrobial infections. Meropenem has a broad spectrum of antibacterial activity against most clinically important Gram-positive and Gramnegative aerobic and anaerobic bacteria with especially high potency against multiresistant Enterobacteriaceae and Pseudornonas aeruginosa. Compared with imipenem, the only other available carbapenem antibiotic, meropenem has the advantage of being dehydropeptidase 1 (DHP-1) stable and therefore does not need to be administered in conjunction with the DHP-1 inhibitor cilastatin. Meropenem is also being evaluated for treatment of resistant pseudomonal infections in cystic fibrosis patients.
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% |
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