Framycetin Sulfate

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NEWSTAR CHEM ENTERPRISE LTD.

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EP grade
Yes
Non-Customized
ISO 9001, Ep9
Adult
Solid
>99%
20kgs/Drum
China
2941909099
Product Description
CERTIFICATE OF ANALYSIS
Drug Name: Framycetin sulfate
Report No.2105001MFG DateMay,30,2021
Batch No.2105001Date of ReleaseMay,30,2021
Batch Size100kgsExpriation DateApril,30,2023
TestSpecificationResult
CharactersA 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
PH6.0-7.06.5
Specific optical rotation+52.5°-+55.5°+54.0°
Related substancesImpurity 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 dryingNMT 8.0%4.8%
Sulphate ashNMT 1.0%<0.3%
Bacterial endotoxinless than 0.8 IU/mg<0.8EU/mg
PotencyNLT 630IU/mg                                                            (dries substance) 640U/mg                               (dried substance)
Conclusion: Complies with  EP9.0
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