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