| Varieties: | Other |
|---|---|
| Component: | Chemical Synthetic Drugs |
| Type: | Other |
| Pharmacodynamic Influential Factors: | Other |
| Storage Method: | Prevent Exceeding Quality Guarantee Period |
| Veterinary Reg. No.: | Other |
| Customization: |
|---|
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| 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. | ||
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