Propantheline Tablets
Action and use
Anticholinergic.
Definition
Propantheline Tablets contain Propantheline Bromide. They are coated.
Content of propantheline bromide, C23H30BrNO3
95.0 to 105.0% of the stated amount.
Identification
Triturate a quantity of the powdered tablets containing 75 mg of Propantheline Bromide with 10 mL of chloroform, filter, evaporate the chloroform and stir the residue with 5 mL of ether until it solidifies. The solid complies with the following tests.
Tests
Xanthanoic acid
Shake the combined ether extracts reserved in the Assay with two 30 mL quantities of 0.1m sodium hydroxide containing 1.5% w/v of sodium chloride. Remove the ether from the combined aqueous extracts by heating on a water bath, add sufficient 0.1m sodium hydroxide to produce 100 mL and dilute 25 mL to 100 mL with 0.1m sodium hydroxide. The absorbance of the resulting solution at the maximum at 248 nm is not more than 0.31, Appendix II B.
Assay
Weigh and powder 20 tablets or more if necessary. Place a quantity of the powder containing 0.5 g of Propantheline Bromide on a sintered-glass filter, add 10 mL of peroxide-free ether, dried over sodium and distilled before use, stir and filter. Repeat the extraction with four 10 mL quantities of the ether and reserve the combined ether extracts for the test for Xanthanoic acid. Extract the residue on the filter with four 10 mL quantities of chloroform, evaporate the combined chloroform extracts to about 10 mL, add 10 mL of mercury(ii) acetate solution and carry out Method I for non-aqueous titration, Appendix VIII A, using crystal violet solution as indicator. Each mL of 0.1m perchloric acid VS is equivalent to 44.84 mg of C23H30BrNO3.