Product Information

Product name

Eltrombopag Olamine

CAS No.

496775-62-3

Molecular Formula

C25H22N4O4·2(C2H7NO)

Molecular Weight

564.6394

Molecular Structure

Quality Standard

99% up by HPLC

Appearance

Red to brown powder

COA

Product Name: Eltrombopag Olamine

Batch No.: 202301

Batch Size: 15kg

Manufacturing Date: 20221202

Test Date:20221218

Retest Date: 20231218

Test Items

Specification

Test Results

Appearance

Red to brown solid.

Brown solid

Solubility

Sparingly soluble in methanol or ethanol.

Sparingly soluble in methanol

Identification (by HPLC)

The retention time of the test product should be consistent with that of the principal peak of the pure reagent.

The retention time of the test product should be consistent with that of the principal peak of the pure reagent.

Related substances

????Largest single impurity

≤?0.1%

0.06%

????Total impurities

≤1.0%

0.09%

Purity

≥?99.0%

99.9%

Assay

98.0%-102.0%

98.6%

Residue on ignition

≤0.2%

0.04%

Loss on drying

≤0.5%

0.06%

Water

≤0.5%

0.06%

Heavy metal

≤?10ppm

< 10ppm

?

Residue solvents

????Methanol

≤0.3%

0.10%

????Ethanol

≤0.5%

0.10%

????Tetrahydrofuran

≤0.072%

0.029%

????Acetic acid

≤0.5%

ND

Conclusion

The product conforms to the requirements of Enterprise standard.