ATROPINE SULPHATE MONOHYDRATE AR

Short Name: ATROPINE SULPHATE MONOHYDRATE

Other Names: a-(Hydroxymethyl)benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester; Tropine tropate

(Confirms to IP)Store at 2-8°C

Chemical Specifications

Appearance : Colourless crystals or a white crystalline powder; odourless

Assay (Potentiometric; on anhydrous basis) : 99.0 - 101.0%

Identifications : To comply IP tests

pH (2% w/v solution) : 4.5 to 6.2

Related substance (by HPLC) :

Individual impurity : Max 0.3%

Sum of all impurities : Max 0.5%

Specific optical rotation (10% w/v solution) : -0.50° to +0.05°

Apoatropine (absorbance of a 0.1 per cent w/v solution in 0.01 M hydrochloric acid at about 245 nm) : Max 0.4

Foreign alkaloids and decomposition products (by TLC) : To comply IP test

Sulphated ash : Max 0.2%

Water (by KF) : Max 4.0%