Silver Sulfadiazine USP

Product Description

PRODUCT SPECIFICATIONS

Name of Product:	SILVER SULFADIAZINE USP
Synonyms:	(4-Amino-N-2-pyrimidinylbenzenesulfonamidato-NN,01)-silver, sulfadiazine silver, silver (I) sulfadiazine, 4-amino-N-(2-pyrimidinyl) benzenesulfonamide silver salt, dermazine, geben, silvadene
CAS No:	22199-08-2

 

SPECIFICATIONS

Sr. No	Criteria	Limit/Specification
1.	Appearance	White to creamy- white, crystalline powder. Odorless to having it slight odor. Is stable in air, but turns yellow on exposure to light.
2.	Solubility	Freely soluble in 30% of ammonia solution; slightly soluble in acetone; practically insoluble in ethanol (95%), chloroform and ether.
3.	Identification
	A. By IR	The IR Spectrum is concordant with the reference spectrum of Silver Sulfadiazine
	B. By HPLC	The RT of the major peak of the Sample solution corresponds t O that of the Standard solution, as obtained in the Assay
	C. Test for Silver	Meets the Requirement of test for Silver
4.	Silver Content	29.3% – 30.5% of Silver is found
5.	Limit of Nitrate (By UV-Vis)	Nmt 0.5%
6.	Organic Impurities (By HPLC )	Name Acceptance Criteria NMT (%) Sulfanilic Acid 0.3% Sulfaguanidine 0.10% Sulfanilamide 0.10% 2-Aminopyrimidine 0.3% Acetylsulfadiazine 0.2% Specified unidentified impurity 0.15% Individual unidentified impurity 0.10% Total Impurities 0.5%
7.	Loss of Drying	NMT 0.5%
8.	Assay (By HPLC)	98.0% – 102.0% on the dried basis

 

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