| Powder: | Yes |
|---|---|
| Customized: | Non-Customized |
| Certification: | ISO 9001, Ep9 |
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| CERTIFICATE OF ANALYSIS | |||
| Drug Name: Framycetin sulfate | |||
| Report No. | 2105001 | MFG Date | May,30,2021 |
| Batch No. | 2105001 | Date of Release | May,30,2021 |
| Batch Size | 100kgs | Expriation Date | April,30,2023 |
| Test | Specification | Result | |
| Characters | A white or yellowish-white hydroscopic powder, very soluble in water, very slightly soluble in alcohol,practically insoluble in acetone. | white powder | |
| Identification | (A) The retention time of a major peak meets the requirements (B) Impurity C meets the requirements ≤3.0% C: identification of sulfate:it gives reacetion of sulphate | (A) Complies (B) 1.94% (C)complies | |
| PH | 6.0-7.0 | 6.5 | |
| Specific optical rotation | +52.5°-+55.5° | +54.0° | |
| Related substances | Impurity A(Neamine):NMT 1.00% | 0.02% | |
| Impurity C:NMT 3.0% | 1.94% | ||
| Total of other impurities:NMT 3.0% | 0.33% | ||
| Sulphate(anhydrous) | 27.0%-31.0% | 29.20% | |
| Loss on drying | NMT 8.0% | 4.8% | |
| Sulphate ash | NMT 1.0% | <0.3% | |
| Bacterial endotoxin | less than 0.8 IU/mg | <0.8EU/mg | |
| Potency | NLT 630IU/mg (dries substance) | 640U/mg (dried substance) | |
| Conclusion: Complies with EP9.0 | |||
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