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