Trimetazidine HCL CAS NO.13171-25-0

items

specifications

results

appearance

white or almost white, crystalline powder, slightly

hygroscopic.

conforms

identification

a: infrared absorption spectrophotometry.

conforms

b: dissolve 25mg in 5ml of water r. 2ml of the solution

gives reaction (a) of chlorides.

conforms

solubility

freely soluble in water, sparingly soluble in alcohol.

conforms

appearance of solution

solution is clear and not more intensely coloured than

reference solution by₆

conforms

related substances

impurities a,b,c,d,e,f,h,i: for each impurity, not more

than 0.1%.

not detected

any other impurity: for each impurity, not more than 0.1%

0.07%

total: not more than 0.2%

0.07%

impurity g: not more than 0.1%, expressed as anhydrous

piperazine

conforms

sulphated ash

0.1% max, determined on 1.0g

0.03%

loss on drying

2.5%max

0.9%

assay

98.5% to 101.5% (dried substance)

99.6%

conclusion

complies with the standard of ep8.0 .