Characteristics:A white or almost white, crystalline powder, soluble in water, freely soluble in methanol, slightly soluble in alcohol.
Impurity A:Any spot due to impurity A is not more intense than the principal spot in the chromatogram obtained with reference solution (c) (0.1 per cent).
Related substances:
(1).Impurity D: not more than 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.05 per cent);
(2).Unspecified impurities: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.10 per cent);
(3).Total: not more than 2.5 times the area of the principal peak in the chromatogram obtained with reference solution (a) (0.25 per cent);
Water:3.9% to 4.4
Assay:99.0% to 100.5%
Iprtropium bromide monohydrate