China GMP Certificate Cefpirome Sulfate, Cefoperazone Sodium & Sulbactam Sodium, Cefoperazone Sodium, Find details about China Cefoperazone Sodium, Cefoperazone Sodium & Sulbactam Sodium from GMP Certificate Cefpirome Sulfate, Cefoperazone Sodium & Sulbactam Sodium, Cefoperazone Sodium
Contents of Testing | Requirements | Results of Analysis |
Description | White crystalline Powder | Meets the requirements |
Identification | Meets the requirements | Meets the requirements |
pH | 4.5~6.5 | 5.0 |
Water | ≤5.0% | 3.2% |
Crystallinity | Meets the requirements | Meets the requirements |
Bacterial endotoxin | ≤0.20 EC/mg | Meets the requirements |
Sterility | Meets the requirements | Meets the requirements |
Particulate matter | Meets the requirements | |
≥10um | NMT 6000/G | |
≥25um | NMT 600/G | |
Assay | 870~1015ug/mg | 937 ug/mg |
| Product name | Cefoperazone Sodium & Sulbactam Sodium 1:1 | |
| Items | Specification | Results |
| Appearance | white or almost white powder | complies |
| Identification | 1) HPLC: The retention time of the two major peaks in the chromatogram of the Assay preparation corresponds to those in the chromatogram of the standard preparation, as obtained in the Assay | complies |
| 2) Sodium reaction | complies | |
| Ph | 3.5-6.5 | 5.2 |
| Clarity and color of solution | clarity ≤1# | <0.5# |
| color ≤Y4# or YG4# | <YG2# | |
| Related substances | Cefoperazone Impurity A ≤1.5% | 0.3% |
| Any other impurity ≤1.5% | 1.2% | |
| Total impurities ≤5% | 2.6% | |
| Water | ≤4.0% | 2.1% |
| Bacterial endotoxins | <0.05EU/mg | <0.05EU/mg |
| Sterility | meets the requirement | complies |
| Visible particles | ≤5/4.0g | complies |
| Particulate matter | ≥10μm particles: ≤6000/4.0g | 335 |
| ≥25μm particles: ≤600/4.0g | 10 | |
| Assay(anhydrous basis) | Cefoperazone (C25H27N9O8S2) ≥435μg/mg | 449μg/mg |
| Sulbactam (C8H11NO5S) ≥445μg/mg | 464μg/mg | |
| Residual solvents | meets the requirements | complies |
| ITEMS | SPECIFICATION | RESULTS |
| Appearance | White to pale yellow Crystalline Powder | Passed |
| Identification | IR Spectrum HPLC RT Sodium | Passed Passed Passed |
| Clarity | Clear | Passed |
| Color of Solution | NMT 0.2(430mm,10% solution) | Passed |
| Specific optical rotation | +56°~+64° | +61° |
| PH | 4.5~6.5 | 5.5 |
| Loss on drying | ≤3.0% | 2.7% |
| Chromatographic purity Individual impurity Total impurity | ≤1.0% ≤3.0% | ≤0.6% ≤2.0% |
| Sterility | Sterile | Passed |
| Bacterial Endotoxins | NMT 0.20 USP EU/mg | Passed |
| Particulate matter | ≥10um NMT 6000 ≥25 um NMT 600 | Passed Passed |
| Assay(HPLC) | 916-964μg/mg | 940μg/mg |
| Product Name | Cefpirome sulfate |
| Quality Standard | JP15 / USP30 |
| Specification | pure powder / containing carbonate sodium mixed powder |
| Appearance | white crystalline powder |
| PH | 1.0-2.6 |
| Assay | 820ug / mg |
| Moisture | ≤0.5% |
| Residue on ignition | ≤0.5% |
| Uses | pharmaceutical raw materials, cephalosporin antibiotic fungi |
| Product name | Packing | Standard |
| Mezlocillin Sodium | 4/5kg/Alu Tin | USP |
| Cefotaxime Sodium | 5/6kg/Alu Tin | USP |
| Ceftriaxone Sodium | 5/6kg/Alu Tin | USP |
| Ceftriaxone Sodium & Sulbactam Sodium | 4/5kg/Alu Tin | USP |
| Piperacillin Sodium | 4/4.5kg/Alu Tin | CP |
| Piperacillin Sodium & Tazobactam sodium | 4/5kg/Alu Tin | USP |
| Ampicillin sodium & Sulbactam Sodium | 4/5kg/Alu Tin | USP |
| Kitasamycin Tartrate | 2/3kg/Alu Tin | CP |
| Cefpirome Sulfate | 4/5kg/Alu Tin | USP |
| Cefoperazone Sodium | 4/5kg/Alu Tin | USP |
| Cefoperazone Sodium & Sulbactam sodium | 4/5kg/Alu Tin | CP |
| Sulbactam sodium | 4/5kg/Alu Tin | USP |
| Trimetazidine Dihydrochloride | 4/5kg/Alu Tin | CP |
| Meclofenoxate Hydrochloride | 4/5kg/Alu Tin | CP |
| Neutral Proteinase | 1/2kg/Alu Tin | CP |
| Imatinib Mesylate | 4/5kg/Alu Tin | |
| Erlotinib Hydrochloride | 4/5kg/Alu Tin | |
| Gefitinib | 4/5kg/Alu Tin |