Product name: Tiotropium bromide monohydrate
Appearance: White or almost white powder
Solubility: Sparingly soluble in methanol
Identification:
a. IR: The infra-red absorption
spectrum is concordant with the spectrum obtained form Tiotropium Bromide WS.
b. UV: The UV spectrum of 0.001% w/v solution in methanol in the range of 350nm to 200nm exhibits a maxima at about 238nm.
Water: Between 3.0～5.0% w/w
Specific Optical Rotation: -0.5°～+0.5°
Residue on ignition: Not more than 0.1% w/w
Particle sizes: Not more than 7.5μm
Heavy metals: 20ppm
Related substance
Single impurity(HPLC): Not more than 0.2%
Total impurities: Not more than 1.0%
Assay: Not less than 99.0%
Product name: Tiotropium bromide monohydrate
Appearance: White or almost white powder
Solubility: Sparingly soluble in methanol
Identification:
a. IR: The infra-red absorption
spectrum is concordant with the spectrum obtained form Tiotropium Bromide WS.
b. UV: The UV spectrum of 0.001% w/v solution in methanol in the range of 350nm to 200nm exhibits a maxima at about 238nm.
Water: Between 3.0～5.0% w/w
Specific Optical Rotation: -0.5°～+0.5°
Residue on ignition: Not more than 0.1% w/w
Particle sizes: Not more than 7.5μm
Heavy metals: 20ppm
Related substance
Single impurity(HPLC): Not more than 0.2%
Total impurities: Not more than 1.0%
Assay: Not less than 99.0%
