Framycetin Sulfate

• Powder: Yes
• Customized: Non-Customized
• Certification: ISO 9001, Ep9
• Suitable for: Adult
• State: Solid
• Purity: >99%
• Model NO.: EP grade
• Transport Package: 20kgs/Drum
• Origin: China
• HS Code: 2941909099
• Production Capacity: 1000kgs/Month

Product Description

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