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）