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TESTS |
JP |
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DESCRIPTION |
odorless white crystalline powder. |
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SOLUBILITY |
very soluble in water, sparingly soluble in ethanol and practically insoluble in ether. |
|
PH |
The pH of a solution of Trimetazidine Hydrochloride (1 in 20) is between 2.3 and 3.3
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MELTING POINT |
About 227°C (with decomposition) |
IDENTIFICATION:
Test A
UV
Test For Chlorides
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A red color should develop.
Ultra- violet absorption spectrum exhibits, maximum between 267 nm and 271 nm. infrared absorption of Trimetazidine Hydrochloride exhibits absorptions at the wave numbers of about 1601 cm¯, 1580 cmmacr;, 1502 cmmacr;, 1416 cmmacr;, 1234 cm¯ and 1039 cm
A solution of Trimetazidine hydrochloride (1 in 50) responds to the qualitative tests for chlorides
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CLARITY AND COLOR OF SOLUTION
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A 10% solution is clear and colorless. |
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HEAVY METALS
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Not more than 10 ppm. |
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ARSENIC
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Not more than 2 ppm |
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RELATED SUBSTANCE
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The spots other than the principal spot and the spot of the starting point from the sample solution are not more intense than the spot from the standard solution. |
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WATER
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Not more than 1.5% |
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RESIDUE ON IGNITION
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Not more than 0.1% (1g) |
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ASSAY
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Trimetazidine Hydrochloride contains not less than 98.0 % of C14H22N2O3, 2HCl calculated on dried basis. |
