| TESTS |
SPECIFICATIONS |
REFERENCE |
| |
| Description |
A pale yellow powder. |
USP/BP/EP |
|
| |
| Solubility |
Practically insoluble in water; slightly soluble in acetone; soluble in dimethylformamide; very slightly soluble in ethanol (96%) and in methanol. |
BP/USP/EP |
| |
| Identification |
(A) The infrared absorption spectrum is concordant with the reference spectrum.
|
USP/BP/EP |
(B) Examined between 240 nm & 450 nm, the solution shows maximum absorption at 354 nm & absorbance at 354 nm is about 0.8. |
USP/BP |
| |
| Clarity of solution |
5% w/v solution in dimethylformamide is clear. |
BP |
| |
| Related Substances |
Impurity A at 350 nm : NMT 0.1 %
Impurity B at 260 nm : NMT 0.1 %
Impurity C at 350 nm : NMT 0.05 %
Impurity D at 350 nm : NMT 0.05 %
Single Unknown Impurity : NMT 0.1 %
Total impurities : NMT 0.3 %
|
BP/EP |
AS Per USP Process - 2
Impurity B at 260 nm : NMT 0.1 %
Impurity C at 350 nm : NMT 0.1 %
Impurity D at 350 nm : NMT 0.1 %
Single Unknown Impurity : NMT 0.1 %
Total impurities : NMT 0.3 %
|
USP |
| |
| Heavy Metals |
Not more than 10 ppm/ Not more than 20 ppm |
USP/EP/BP |
| |
| Loss on Drying |
Not more than 0.5 % w/w |
BP/USP/EP |
| |
| Sulphated Ash |
Not more than 0.1 % w/w |
BP/EP |
| |
| Assay |
NLT 99.00 % and NMT 100.50 % of C14H13N3O4S2, on dried basis. / NLT 99.00 % and NMT 101.00 % of C14H13N3O4S2, on dried basis. |
USP/BP/EP |
