Naltrexone hydrochloride EP ≥98.0% API Pharmaceutical made in china CAS NO.16676-29-2

Appearance

White or almost white powder，very hygroscopic

Solubility

Freely souble in water，slightly soluble in ethanol 96%， practically insoluble in methylene chloride

Identification 

1）IR:meet the requirements

2）It gives reaction（a）of chloride

Residue on ignition

≤0.1%

Specific optical rotation

-187°~ -195°

Water 

≤10%

Relate substance（HPLC)

ImpurityA：≤0.1%

ImpurityB：≤0.1%

ImpurityC：≤0.2%

ImpurityD：≤0.2%

ImpurityE：≤0.2%

ImpurityF：≤0.2%

ImpurityG：≤0.2%

ImpurityH：≤0.1%

ImpurityI：≤0.1%

ImpurityJ：≤0.1%

Each other impurity：≤0.1%

Total impurities：≤1.0%

Assay (HPLC)

98.0~102.0% (On drid basis）

Residual solvents

Toluene content：≤890ppm