| Function: | Antibiotic and Antimicrobial Agents |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
| Type: | API |
| State: | Powder |
| Volatile: | Not Volatile |
| Samples: |
|---|
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| Name of product | Amoxicillin and Clavulanate postassium(4:1) | ||
| Tests | Specifications | Results | |
| Characters | A white to slightly yellow powder .hygroscopic | A white powder , hygroscopic | |
| Identification | The retention time of the two major peak in the chromatogram of the Assay preparation corresponds to that exhibited in the chromatogram of the standard preparation. | Conforms | |
| Water | 9.0% ~12.0% | 10.2% | |
| PH | 3.5~7.5 | 5.3 | |
| Related substances | Any impurity ≤2.0% (calculated on the basis of amoxicillin peak areas in the chromatogram of reference solution) | 0.03% | |
| Total impurities ≤5.0% (calculated on the basis of amoxicillin peak areas in the chromatogram of reference solution) | 0.06% | ||
| Assay | Amoxicillin(C16 H19 N3 O5S)≥695 μg/mg, | Amoxicillin 772 μg/mg | |
| Clavulanic acid(C8 H9 NO5) ≥ 176μg/mg, | Clavulanic acid 193 μg/mg | ||
| The ratio of Amoxicillin to Clavulanic acid should be 3.6~ 4.4 | 4.0 | ||
| Name of product | Amoxicillin and Clavulanate postassium(7:1) | ||
| If you need 7:1, please contact our customer service | |||
| Name of product | Clavulanate Potassium-Microcrystalline Cellulose(1:1) | ||
| Tests | Specifications | Results | |
| Appearance | White or almost white powder, hygroscopic | Almost white powder, hygroscopic | |
| Identification | (l)HPLC: positive | Positive | |
| (2) Reaction (b) of potassium: positive | Positive | ||
| (3) Reaction of cellulose: positive | Positive | ||
| pH | 4.8 - 8.0 | 5.7 | |
| Polymeric impurities and other impurities absorbing at 278 nm | NMT 0.40 | 0.033 | |
| Water | NMT2.5% | 0.46% | |
| Related substances | Impurity E: NMT 1.0% | 0.014% | |
| Impurity G: NMT 1.0% | 0.0017% | ||
| Any other single impurity (major): NMT 0.10% | <0.05% | ||
| Total impurities: NMT 2.0% | 0.016% | ||
| Assay (HPLC) | 91.2% ~107.1% (as content of potassium clavulanate stated on the label) | 100.4% | |
| CLAV.ACID(as is)38.3%~45.0% | 42.1% | ||
| CLAV. POT. (as is)45.6%~53.5% | 50.2% | ||
| Conclusion | Conforms to the requirements of EP. | ||
| Name of product | Clavulanate Potassium-Silicon Dioxide(1:1) | |
| Tests | Specifications | Results |
| Appearance | A white or almost white powder, hygroscopic | A white powder, hygroscopic |
| Identification | (1) The principal peak in the chromatogram obtained with the test solution is similar in retention time to the principal peak in the chromatogram obtained with reference solution (a). | Conforms |
| (2)lt gives reaction (b) of potassium. | Conforms | |
| (3) It gives the reaction of silicates | Conforms | |
| PH | 4.8 ~8.0 | 5.1 |
| Absorbance | ≤0.40(278nm) | 0.064 |
| Related substances | Impurity E≤1.0% | 0.09% |
| Impurity G≤1.0% | <Reporting threshold limit0.05% | |
| Any other impurity ≤ 0.2% | <Reporting threshold limit0.05% | |
| Total impurities≤ 2.0% | 0.09% | |
| water | ≤2.5% | 0.53% |
| Residual Solvents | Acetone≤5000ppm | 48ppm |
| 1-butanol≤5000ppm | 909ppm | |
| Assay | It contains Potassium Clavulanate(C8H8KNO5)48.0%~53.5%,calculated on the anhydrous basis. | 49.9% |
| Conclusion | The results conform with EP and Enterprise standard. | |
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