Tiotropium Bromide(API)

PH (2.2.3) The pH of the solution is 6.0 to 7.5. Appearance of solution (2.2.1) The solution is clear,or it is not more opalescent than reference suspension Related substances Total impurity: the area of the corresponding peak of the total impurity in the chromatogram obtained with test solution is not more than the area of the main peak in the chromatogram obtained with reference solution (1.0 per cent), Loss on drying(2.2.32) Not more than 4.5%,determined on 1.000g by drying in an oven at 100°C to 105°C Residue on Ignition The weight of the residue is not more than 0.2%. Use 1 g. Assay 99.0%-100.5%