Listing ID #7080928
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SR.NO |
TEST |
SPECIFICATION |
RESULTS |
1. |
Appearance |
White to creamy- White, Crystalline powder, free flowing, Odorless to having a slight odour. Is stable in air, but turns yellow on exposure to light. |
Complies |
2. |
Solubility |
Free soluble in 30% ammonium solution: slightly soluble in acetone; Practically insoluble in alcohol, in chloroform and in ether. Decomposes in moderately strong mineral acids. |
Complies |
3. |
Identification: a.     Infrared Absorption b.     HPLC   c. Test for silver |
A. IR test should be concordant with IR of standard. B. The retention time of the major peak of the sample solution corresponds to the standard solution, as obtained in the assay. C. Meets the requirements. |
Complies |
4. |
Loss on drying |
0.50 % Max |
0.24% |
5. |
Assay on dried basis |
NLT 98% and NMT 102.0%calculated on dried basis |
100.52% |
6. |
Nitrate |
NMT 0.1 % Max. |
0.044% |
7. |
Silver Content |
NLT- 29.3 % and NMT 30.5% silver found |
29.78% |
8. |
Organic Impurities a.     Sulfanilic acid b.     Sulphaguanidine c.      Sulfanilamide d.     2-Aminopyrilidine e.     Sulfadiazine f.      Acetyl Sulphadiazine g.     Specified unidentified Impurity h.     Individual unidentified Impurity i.       Total Impurity |
 A)    Not more than 0.3% B)     Should be Absent C)     Should be Absent D)    Not more than 0.3% E)     Should be Absent F)     Not More than 0.2% G)    Not More than 0.15% H)    Not More than 0.10% I)      Not More than 0.5%   |
 a.     Not Detected b.     Not Detected c.      Not Detected d.     Not Detected e.     Not Detected f.      Not Detected g.     Not Detected h.     Not Detected i.       Not Detected  |
 |
Physical Properties |
||
1. |
Particle Size |
 |
 |
A. |
Average Particle Size |
NMT 10 µm |
100 %40 µm |