| Customization: | Available |
|---|---|
| Function: | Antibiotic and Antimicrobial Agents |
| Certification: | GMP |
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Test Item |
Analysis Specification |
Result |
Description |
crystalline powder |
Conforms |
Melting range |
129°C~132°C |
130.8°C-131°C |
Loss on drying |
≤0.5% |
0.20 % |
Specific rotation |
-58°~-62°(C=1,in CH3OH) |
-61.05° |
Sulphated ash |
≤0.1% |
0.08 % |
Heavy metals |
≤10ppm |
Conforms |
Chlorides |
≤0.02% |
Conforms |
Sulfates |
≤0.02% |
Conforms |
Fluorine |
14.7%~17.9% |
15.2% |
Residual solvent |
Methanol ≤0.2% Isopropanol ≤0.2% Ethyl acetate≤0.2% Chloroform ≤0.2% |
0.0% 0.0% 0.0% 0.0% |
Related substances (HPLC) |
Single impurity ≤0.2% Total impurities ≤0.5% |
0.05% 0.08% |
Assay |
≥99.5% |
99.92% |
| Product name | Piperacillin Sodium/Tazobactam sodium (8:1) | |
| Items | Specification | Results |
| Appearance | white or almost white powder | white powder |
| Identification | (1) two major peaks in the chromatogram of the assay preparation correspond to those in the chromatogram of the Standard preparation |
complies |
| (2) Yields the character flame reaction of sodium salts | complies | |
| Constituted solution | meet the requirement | complies |
| PH | 5.0-7.0 | 6.09 |
| Particulate matter | ≥10 μm, ≤ 6000 units | 409.0 units |
| ≥25 μm, ≤ 600 units | 88.0 units | |
| Tazobactam Related Compound A 2 | ≤ 1.0% | 0.04% |
| Piperacillin impurity 4 3 | ≤ 1.0% | 0.03% |
| Piperacillin impurity 1 4.5 | ≤ 1.0% | 0.005% |
| Piperacillin Related Compound A 5.6 | ≤ 5.0% | 0.1% |
| Piperacillin Related Compound C 7 | ≤ 1.0% | 0.38% |
| Piperacillin impurity 5 3 | ≤ 1.0% | 0.08% |
| Piperacillin impurity 6 3 | ≤ 1.0% | 0.03% |
| Any individual unspecified impurity | ≤ 1.0% | 0.12% |
| Toal of impurities other than Piperacillin Related Compound A | ≤ 5.0% | 1.01% |
| Water | ≤2.5% | 0.82% |
| Bacterial endotoxins | Not more than 0.08 USP endotoxin Unit/1 mg of mixture of piperacillin and tazobactam |
<0.08EU |
| Sterility | sterile | complies |
| Assay | Content of Piperacillin ≥78% | 82.59% |
| Content of Tazobactam ≥9.6% | 12.18% | |
| Conclusion: | conform to USP37 | |
| Product name | Ampicillin Sodium and Sulbactam Sodium 2:1 | |
| Items | Specification | Results |
| Appearance | a white powde | complies |
| Identification | conform | complies |
| Ph | 8.0~10.0 | 8.6 |
| Water | ≤2.0% | 0.5% |
| Visible particles | conform | complies |
| Crystallinity | birefringen | complies |
| Assay | Ampicillin ≥563μg/mg | 601μg/mg |
| Sulbactam ≥280μg/mg | 300μg/mg | |
| Sterility | conform | complies |
| Bacterial endotoxins | <0.17EU/mg | complies |
| Methylene Chloride | ≤600ppm | 329ppm |
| Ethanol | ≤5000ppm | 1063ppm |
| Conclusion: complies with USP36. | ||
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 |
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