Product

Epirubicin Hydrochloride

Batch Size

58g

Batch No.

20230507

Report Date

2023-05-07

Manufacture Date

2023-05-07

Expiration Date

2026-05-06

Items

 Specification

Result

Description

Orange red crystalline powder

Orange red powder

Identification

IR

Conform to standard

PH

4.0～5.5

5.1

Water

≤4.0%

1.0%

Acetone

≤15000ppm

1200ppm

Ethanol

≤5000ppm

3000ppm

Methanol

≤1000ppm

100ppm

Ethyl Acetate

≤5000ppm

None

Methylene Chloride

≤500ppm

None

Total Residual Solvents

≤20000ppm

4300ppm

Impurity A

≤1.0%

0.03%

Impurity C

≤1.0%

0.03%

Any Other Impurity

≤0.5%

0.03%

Total Impurities

≤2.0%

0.3%

Residue on ignition

≤0.1%

0.05%

Heavy metals

≤0.001%

＜0.001%

Related substances(HPLC)

Total impurities≤2.0%

1.1%

Assay(HPLC)

97.0～102.0%

99.7%

Conclusion

Conform with EP6.0 standard