Specification:
Item | Specifications | Results |
Appearance | White or almost white crystalline powder hygroscopic | White powder,hygroscopic |
Identification Tests | HPLC:The principal peaks in the chromatogram obtained with the test solution is similar in retention time to that obtained with reference solution | Conform |
PH | 4.8~8.6 | 5.1 |
Water | NMT 11.0% | 9.2% |
Ratio of compound | Amoxicillin:clavulanic acid(1.9~2.1):1 | 2.0:1 |
Related substances | Any individual impurity(largest)NMT 2.0% | 0.12% |
Total impurities NMT 5.0% | 0.52% | |
Assay on the anhydrous basis | Clavulanic acid NMT25.8% | 30.9% |
Amoxicillin NMT 59.3% | 63.2% | |
Conclusion | The results conforms with enterprise standards |
Packaging details:
Packaging details: | 25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
Storage: | Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
Shelf Life: | 5 years if sealed and store away from direct sun light. |
WHITE SWAN PHARMACEUTICAL
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