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Bulk Active : Trimetazidine DiHydrochloride
MOLECULAR FORMULA : C14H22N2O3
MOLECULAR WEIGHT : 339.3
Pharmacologic Activity :
Anti-anginal
CAS No : 13171-25-0
Specifications : JP
Regulatory compliance : eDMF(CTD)
| TESTS | EP 7.4/BP 2013 |
| Appearance | White or almost white, crystalline powder slightly hygroscopic. |
| Solubility | Freely soluble in water, sparingly soluble in alcohol. |
IDENTIFICATION A. Infrared Absorption Spectrophotometry B Test for Chlorides |
Infrared adsorption spectrum of sample should be concordant with that of spectrum of working standard Solution Gives reaction(a) of chlorides |
| Appearance of solution |
The solution should be clear and not more intensely coloured than reference solution BY6 |
| Related substance By HPLC Impurities A Impurity I Impurity B Impurity C Impurity D Impurity E Impurity F Impurity H Any other Impurity Total Impurities |
Not more than 0.1 % w/w Not more than 0.1% w/w Not more than 0.1 % w/w Not more than 0.1 % w/w Not more than 0.1 % w/w Not more than 0.1 % w/w Not more than 0.1 % w/w Not more than 0.1 % w/w Not more than 0.1 % w/w Not more than 0.2 % w/w |
| Impurities G By TLC | Any secondary spot due to impurity G is not more intense than the spot in the chromatogram obtained with the reference solution. (0.1 per cent, expressed as anhydrous piperazine) |
| Loss on drying | Maximum 2.5 % w/w |
| Sulphated ash | Maximum 0.1 % w/w |
| Assay By Titrimetry ( On dried basis ) | Not less than 98.5% & Not more than 101.5% (w/w). |
