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SILVER SULFADIAZINE USP

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Silver Sulfadiazine is an inorganic compound with antibiotic properties that is used to treat infection in severely burned areas of skin. It prevents the growth of bacteria that could infect an open wound.


Macsen Laboratories is the leading Manufacturer and Supplier of Silver Sulfadiazine USP.
WHO GMP, COPP, EUGMP - WC & USDMF is now available for Silver Sulfadiazine.
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
Pubchem CID 24424
Pubchem SID 462730477
WHO-GMP ✓
WC ✓
DMF ✓
US-DMF ✓

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
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
Silver Sulfadiazine USP also available in micronized form upto 5 microns particle size.
Buy the best quality Silver Sulfadiazine USP for burn cream & ointment application from Macsen Laboratories.
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