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ANALYSIS REPORT
|
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. |
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