(bye per' i den).
» Biperiden contains not less than 98.0 percent and not more than 101.0 percent of C21H29NO, calculated on the dried basis.
Packaging and storage Preserve in well-closed, light-resistant containers.
USP Reference standards 11
Solution: 900 µg per mL. Transfer about 180 mg of it, accurately weighed, to a 200-mL volumetric flask, add 1 mL of lactic acid, dilute with water to volume, and mix. Absorptivities, at about 257 nm, calculated on the dried basis, do not differ by more than 3.0%.
C: Dissolve about 20 mg in 5 mL of phosphoric acid: a green color is produced.
D: Dissolve 200 mg in 80 mL of water with the aid of 0.5 mL of 3 N hydrochloric acid, warming, if necessary, to effect solution, and then cool. To 5 mL of the solution add 1 drop of hydrochloric acid and several drops of mercuric chloride TS: a white precipitate is formed. To a second 5-mL portion of the solution add bromine TS dropwise: a yellow precipitate forms which redissolves on shaking, and finally, upon the addition of more bromine TS, a permanent precipitate is formed.
Melting range, Class I 741: between 112 and 116.
Loss on drying 731 Dry it at 105 for 3 hours: it loses not more than 1.0% of its weight.
Residue on ignition 281: not more than 0.1%.
Ordinary impurities 466
Test solution: methanol.
Standard solution: methanol.
Eluant: a mixture of methanol and ammonium hydroxide (100:1.5).
Assay Dissolve about 500 mg of Biperiden, accurately weighed, in 20 mL of benzene, add 2 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 31.15 mg of C21H29NO.
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USP35NF30 Page 2362Pharmacopeial Forum: Volume No. 29(6) Page 1851