| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Non-Customized |
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| Items | Requirements | Result |
| Appearance | White,almost white,or tan to brown powder. | Almost white powder |
| Identification: | Infrared Absorption ,complies | Complies |
| Clarity of solution | Clear | Clear |
| Assay(microbial) (anhydrous basis ) |
NLT 900 μg/mg | 1027 µg/mg |
| Heavy metals | NMT 30ppm | <30ppm |
| Limit of mono dechlorovancomycin | NMT 4.7% | 3.0% |
| pH | 2.5-4.5 | 2.9 |
| Water | NMT 5.0% | 2.3% |
| Composition of Vancomycin | Vancomycin B:NLT 85.0% | 95.1% |
| Any peak other than the main peak:NMT 5.0% | 1.3% | |
| Sterility | Sterility | Sterility |
| Bacterial endotoxins | NMT 0.33 EU/mg of vancomycin | Complies |
| Conclusion | Complies with current USP | |
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