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Trimetazidine DiHydrochloride

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).