Silver Sulfadiazine USP

Silver Sulfadiazine USP

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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. NoCriteriaLimit/Specification
1.AppearanceWhite to creamy- white, crystalline powder. Odorless to having it slight odor. Is stable in air, but turns yellow on exposure to light.
2.SolubilityFreely soluble in 30% of ammonia solution; slightly soluble in acetone; practically insoluble in ethanol (95%), chloroform and ether.
3.Identification
A. By IRThe IR Spectrum is concordant with the reference spectrum of Silver Sulfadiazine
B. By HPLCThe 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 SilverMeets the Requirement of test for Silver
4.Silver Content29.3% – 30.5% of Silver is found
5.Limit of Nitrate (By UV-Vis)Nmt 0.5%
6.Organic Impurities (By HPLC )
NameAcceptance Criteria NMT (%)
Sulfanilic Acid0.3%
Sulfaguanidine0.10%
Sulfanilamide0.10%
2-Aminopyrimidine0.3%
Acetylsulfadiazine0.2%
Specified unidentified impurity0.15%
Individual unidentified impurity0.10%
Total Impurities0.5%
7.Loss of DryingNMT 0.5%
8.Assay (By HPLC)98.0% – 102.0% on the dried basis

 

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