| S.No |
Test |
Specification |
Result |
| 1.0 |
Description |
A White or almost white powder |
Almost white powder |
| 2.0 |
Solubility |
Soluble in Methylene chloride sparingly soluble in alcohol and practically insoluble in water |
Soluble in Methylene chloride sparingly soluble in alcohol and practically insoluble in water |
| 3.0 |
Identification |
| 3.1 |
By IR |
IR absorption spectrum of the sample Potassium dispersion should be concordant with similarly recorded spectrum of olmesartan medoxomil working standard |
Complies |
| 3.2 |
By HPLC |
The Retention time of major peak in the chromatogram of Assay preparation corresponds to that in Chromatogram of the standard
preparationas obtained in the assay |
Complies |
| 4.0 |
Loss on Drying (% w/w) |
NMT 0.50% |
0.18% |
| 5.0 |
Residue on ignition (%w/w) |
NMT 0.10% |
0.02% |
| 6.0 |
Heavy metals |
NMT 10ppm |
Less than 10 ppm |
| 7.0 |
Related Substances By HPLC |
|
| 7.1 |
Any Individual imppurity |
NMT 10 ppm |
0.20% |
| 7.2 |
Total Impurities |
NMT 1.0% |
0.44% |
| 8.0 |
Assay by HPLC
(on dried basis %w/w) |
98.0% - 102.0% |
99.5% |
| 9.0 |
Residual Solvents |
| 9.1 |
Acetonitrile |
NMT 410 ppm |
Not detected |
| 9.2 |
Ethyl Acetate |
NMT 5000 ppm |
450 ppm |
| |
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