| Function: | Antibiotic and Antimicrobial Agents |
|---|---|
| Grade Standard: | Medicine Grade |
| Type: | API |
| State: | Powder |
| Volatile: | Not Volatile |
| Standard: | Ep10/USP43/IP2018 |
| Samples: |
|---|
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Audited Supplier | Product | Clarithromycin | According to | EP10/USP43/IP2018 | |
| Tests | Acceptance Criteria | Results | ||
| Characters | Appearance | White or almost white, crystalline powder. | White crystalline powder. | |
| Solubility | Soluble in acetone,methylene chloride; slightly soluble in anhydrous ethanol, in methanol, and in acetonitrile, and in phosphate buffer at pH values of 2 to 5; practically insoluble in water. | / | ||
| Identification | IR: Conforms to the spectrum of Clarithromycin RS. | conforms | ||
| The retention time of the major peak of the Sample solution corresponds to that of Standard solution, as obtained in the Assay. | conforms | |||
| Appearance of solution | (0.500g/50.0ml methylene chloride.) Clear or not more opalescent than reference suspension II and not more intensely coloured than reference solution Y7. | conforms | ||
| Specific optical rotation | -94 0 ~ -102 ° (Anhydrous substance, 10mg/ml methylene chloride) | -98.6° | ||
| Water | ≤2.0% | 0.26% | ||
| Residue on Ignition | ≤0.2% | 0.04% | ||
| Crystallinity | Meets the requirements | conforms | ||
| pH | 8.0 ~10.0 | 9.1 | ||
| (HPLC) Related substances | Impurity A | ≤1.0% | 0.27% | |
| Impurity B | ≤1.0% | <0.10% | ||
| Impurity C | ≤1.0% | Not detected | ||
| Impurity D | ≤1.0% | 0.23% | ||
| Impurity E | ≤1.0% | 0.43% | ||
| Impurity F | ≤1.0% | 0.14% | ||
| Impurity G | ≤1.0% | <0.10% | ||
| Impurity H | ≤1.0% | <0.10% | ||
| Impurity I | ≤1.0% | Not detected | ||
| Impurity J | ≤1.0% | Not detected | ||
| Impurity K | ≤1.0% | Not detected | ||
| Impurity L | ≤1.0% | Not detected | ||
| Impurity M | ≤1.0% | Not detected | ||
| Impurity N | ≤1.0% | Not detected | ||
| Impurity O | ≤1.0% | Not detected | ||
| Impurity P | ≤1.0% | Not detected | ||
| Any impurity greater than 0.4% | Not more than 4 | 1 | ||
| Any unspecified impurity | ≤1.0% | Not detected | ||
| Total impurities | ≤3.5% | 1.1% | ||
| (HPLC) Assay | C38H69NO13 96.0% ~102.0% (Anhydrous substance) | 99.1% | ||
| Residual solvents (GC) | Ethanol≤5000ppm | Not detected | ||
| Note:Bluk density:0.52g/ml;Tapped density: 0.63g/ml After risk evaluation, elemental impurities meet the requirements.  |
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