| Function: | Antibiotic and Antimicrobial Agents, Semi Synthetic Broad Spectrum Penicillin |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
| Type: | API |
| State: | Powder |
| Volatile: | Not Volatile |
| Samples: |
|---|
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| Name of Product | Amoxicillin Trihydrate | Packing | 25Kg/Drum |
| Tests | Specification | Results | |
| Description | White, practically odorless, crystalline powder | conforms | |
| Identification | The IR spectrum obtained with the substance to be examined should correspond with that obtained with USP Amoxicillin RS. The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the Assay. |
conforms | |
| Crystallinity | Show birefringence and extinction positions | conforms | |
| pH | 3.5 ~6.0 | 4.9 | |
| Water | 11.5% ~14.5% | 13.1% | |
| Dimethylaniline | ≤20ppm | Not detected | |
| Organic impurities | |||
| Impurity I | ≤1.0% | Not detected | |
| Impurity D1 | ≤1.0% | Not detected | |
| Impurity D2 | ≤1.0% | 0.05% | |
| Impurity A | ≤0.5% | Not detected | |
| Impurity G | ≤1.0% | Not detected | |
| Impurity E1 | ≤1.0% | Not detected | |
| Impurity E2 | ≤1.0% | Not detected | |
| Impurity M | ≤1.0% | Not detected | |
| Impurity C | ≤1.0% | Not detected | |
| Impurity J | ≤1.0% | 0.04% | |
| Impurity L | ≤1.0% | Not detected | |
| Any unspecified individual impurity | ≤1.0% | 0.05% | |
| Total impurities | ≤5.0% | 0.21% | |
| Assay | 900 ~1050μg/mg of amoxicillin (C16H19N3O5S) on the anhydrous basis | 1006μg/mg | |
| Note: Dimethylaniline is not used in the manufacturing process of this product and is not detectable in final products. It complies with USP. | |||
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