Eltrombopag Olamine 496775-62-3

Product Information

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.