Propantheline Tablets

General Notices

Action and use

Anticholinergic.

Definition

Propantheline Tablets contain Propantheline Bromide. They are coated.

The tablets comply with the requirements stated under Tablets and with the following requirements.

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.

A. Dissolve 60 mg in 2 mL of water, add 2 mL of 5m sodium hydroxide, boil for 2 minutes, cool slightly, acidify with 2m hydrochloric acid, heat to boiling, add ethanol (96%) drop wise until the precipitate just dissolves, cool and filter. The melting point of the residue, after washing with water, recrystallising from ethanol (50%) and drying at 105° for 1 hour, is about 215°, Appendix V A. The crystals dissolve in sulfuric acid to produce a bright yellow solution which fluoresces strongly in ultraviolet light (365 nm).
B. Yields the reactions characteristic of bromides, Appendix VI.

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.