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Ertapenem Sodium
High Quality Ertapenem Sodium
ITEM | Standard |
Appearance | White to off-white crystalline powder |
Identification | IR |
Solubility | Freely soluble in N,N-Dimethylformamide and insoluble in water |
Loss on Drying (Dry 1.0g sample at 105°C for 3 hrs) | ≤ 0.5% |
Specific Optical Rotation | -13.0°- -16.0° |
Residue on ignition | ≤ 0.1% |
Heavy metals | ≤20ppm |
Content of Triethylamine | ≤800ppm(By GC) |
Residual slovents | Methanol ≤3000ppm Dichloromethane≤600ppm Diisorpopyl ehter≤500ppm Toluene≤590ppm N,N Dimethylformamide≤880ppm |
Chromatographic purity | Impurity at RRT 0.17≤ 0.50% Impurity at RRT 1.22≤ 0.20% Highest unknown impurity≤ 0.10% Total impurities≤ 1.0% |
Assay(HPLC) | 98.0%-102.0% |
1) Ertapenem Sodium is a novel carbapenem antibiotic, penicillin-binding protein with (PBP) binding, interfere with
bacterial cell wall synthesis, resulting in inhibition of bacterial growth and reproduction, a small number of cell lysis.
2)Ertapenem has been shown to be active against most isolates of the following micro-organisms in vitro and in
clinical infections.
3) Ertapenem Sodium can cure the below Severe infections: complicated intra-abdominal infections, complicated skin and soft tissue infections, community-acquired pneumonia, complicated urinary tract infections, acute pelvic infections, severe bacterial infections and other Enterobacteriaceae.