Listing ID #7125243
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SR.NO |
TESTS |
SPECIFICATION |
RESULTS |
1. |
Description |
Yellow color crystalline powder |
Complies |
2. |
Identification |
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a)Â Â Â Â Â By TLC |
The principal spot obtained from the sample solution should correspond that of standard solution |
Complies |
|
b)Â Â Â Â By HPLC |
The retention time of the major peak in the chromatogram of the sample should correspond to that in the chromatogram of the standard. |
Complies |
|
c)Â Â Â Â Â Melting Range |
Between 137C to 140C |
138C - 139C |
|
3. |
Loss on drying at 80C |
NMT 0.50 % |
0.45% |
4. |
Related Substance by |
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a) |
2-Amino-3,5-dibromo benzoic acid (IMP - A at RRT about 0.15) |
Not more than 0.50 % |
0.20% |
b) |
2-Amino-3,5-dibromo benzyl alcohol (IMP - A at RRT about 0.5) |
Not more than 0.50 % |
0.21% |
c) |
Unknown impurity |
Not more than 0.50 % |
0.10% |
d) |
Total impurity |
Not more than 2.00% |
0.80% |
5 |
Assay By titration |
Between 98% to 102% (w/w) |
99.80% |
6 |
Sulphated Ash |
Not more than 0.1% |
0.08% |