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Bulk Active : Trimetazidine DiHydrochloride
MOLECULAR FORMULA : C12H6N2O8S Sr2 . 8 H2O
MOLECULAR WEIGHT : 657.5
Pharmacologic Activity :
Anti-Osteoporosis
CAS No : 674773-15-0
Specifications : In-house
Regulatory compliance : eDMF
| TESTS | EP 7.4/BP 2013 |
| Appearance | Pale yellow to yellow powder |
| Solubility | Sparingly soluble in 1% Hydrochloric acid |
IDENTIFICATION A. IR B HPLC |
Infrared absorption spectrum of sample should be concordant with the reference spectrum of Strontium ranelate working reference standard. In test of Assay,the retention time of principal peak from the sample should match that of working standard sample. |
| Loss on drying | Between 20.0% to 24.0%w/w, |
| pH |
6.5-7.8 |
| Related substance(HPLC) Single impurity Total impurities |
NMT 0.50% NMT 1.00% |
| Assay by HPLC | Not less than 97.0% & not more than 101.0% calculated with reference to dried basis. |
| Strontium content | 25.0% to 28.0%w/w |
