Oxybutynin chloride USP 97%min supplier Pharmaceutical API Urinary system drugs made in china CAS NO.1508-65-2

appearance

white or almost white crystalline powder

identification

ir:the ir absorption spectrum of sample corresponds to that of the reference one.

melting point

124~129℃

loss on drying

≤3.0%

residue on ignition

≤0.1%

heavy metals

≤20ppm

chloride content

8%~10%（calculated on dried basis）

stacking density

0.35~0.70g/cm³

granularity

10%<50µm

50%<120µm

90%<220µm

related substance

impurity a:≤0.5%

diphenyl analog of oxybutynin chloride：≤0.1%

impurity b:≤1.0%

impurityc:≤1.0%

cyclohexenyl analog of oxybutynin chloride：≤1.0%

ethylpropyl analog of oxybutynin chloride：≤0.1%

unspecified impurities：≤0.1%

total impurities：≤1.0%

residual solvents

isopropyl ether:≤500ppm

cyclohexane:≤2500ppm

methanol:≤3000ppm

assay

97.0~102.0%（calculated on dried basis）