Product

Trimetazidine Hcl

Batch no

202110101

Muanfacturing date

Jan.10.2021

Report date

Jan.15.2021

Batch size

500.0kg

Retest date

Jan.09.2024

According to

EP9

packaging

25kgs/drum

Items

Specification

Results

Description

White or almost white,crystalline powder,slightly hygroscopic,Free solution in water,sparingly soluble in alcohol.

Complies

Identification

IR

Complies

Chlorides reaction

Complies

Appearance of solution

Clear and not more intensely colored than reference solution

Complies

Related substance

Impurity A,B,C,D,E,F,H,I not more than 0.1%

Complies

Impurity G,not more than 0.1%

Complies

Any other impurity,not more than 0.1%

Complies

Total not more than 0.2%

Complies

Heavy metals

Not more than 0.002%

Complies

Loss on drying

Not more than 2.5%

0.06%

Sulphated ash

Not more than 0.1%

0.03%

Residual ash

Isopropyl alcohol,not more than 5000ppm

450ppm

Ethanol,not more than 5000ppm

680ppm

Assay

Not less than 98.5% and not more than 101.5 percent of C14H24CL2N2O3,calculated on the dried basis.

99.8%

Conclusion

Trimetazidine Hcl complies with the requirements of EP9 Standard.