Orphenadrine Hydrochloride Tablets

General Notices

Action and use

Anticholinergic.

Definition

Orphenadrine Hydrochloride Tablets contain Orphenadrine Hydrochloride.

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

Content of orphenadrine hydrochloride, C18H23NO,HCl

92.5 to 107.5% of the stated amount.

Identification

Extract a quantity of the powdered tablets containing 0.15 g of Orphenadrine Hydrochloride with chloroform, filter and evaporate the filtrate to dryness. The residue complies with the following tests.

A. Dissolve 5 mg in 2 mL of sulfuric acid. An orange-red colour is produced.
B. Dissolve 50 mg in 10 mL of ethanol (50%), add 10 mL of picric acid solution R1 and allow to stand. The melting point of the precipitate, after recrystallisation from ethanol (96%), is about 89° or about 107°, Appendix V A.
C. Yields reaction A characteristic of chlorides, Appendix VI.

Assay

Weigh and powder 20 tablets. Dissolve a quantity of the powder containing 70 mg of Orphenadrine Hydrochloride as completely as possible in a mixture of 5 mL of water and 5 mL of 2m hydrochloric acid. Without delay extract with four 15 mL quantities of chloroform, filter the combined extracts and evaporate to about 20 mL. Carry out Method I for non-aqueous titration, Appendix VIII A, using 0.02m perchloric acid VS, adding 2 mL of mercury(II) acetate solution and determining the end point potentiometrically. Each mL of 0.02m perchloric acid VS is equivalent to 6.118 mg of C18H23NO,HCl.