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喜樹堿 黃體酮 噻菌靈/噻苯咪唑 硫酸新霉素 紅霉素
檢驗報告書
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
Chlorides reaction
Appearance of solution
Clear and not more intensely colored than reference solution
Related substance
Impurity A,B,C,D,E,F,H,I not more than 0.1%
Impurity G,not more than 0.1%
Any other impurity,not more than 0.1%
Total not more than 0.2%
Heavy metals
Not more than 0.002%
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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