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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 |
✓ |
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 |
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