(bye per' i den hye'' droe klor' ide).
1-Piperidinepropanol, -bicyclo[2.2.1]hept-5-en-2-yl--phenyl-, hydrochloride.
-5-Norbornen-2-yl--phenyl-1-piperidinepropanol hydrochloride [1235-82-1].
» Biperiden Hydrochloride contains not less than 98.0 percent and not more than 101.0 percent of C21H29NO·HCl, calculated on the dried basis.
Packaging and storage Preserve in well-closed, light-resistant containers.
USP Reference standards 11
B: Ultraviolet Absorption 197U
Solution: 1 mg per mL.
Absorptivities at 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: To 5 mL of a solution (1 in 500) add bromine TS dropwise: a yellow precipitate, which dissolves on shaking, is formed. Addition of more bromine TS produces a precipitate that does not dissolve on shaking.
E: A 5-mL portion of a solution (1 in 500) responds to the tests for Chloride 191.
Loss on drying 731 Dry it at 105 for 3 hours: it loses not more than 0.5% of its weight.
Ordinary impurities 466
Test solution: methanol.
Standard solution: methanol.
Eluant: a mixture of methanol and ammonium hydroxide (100:1.5).
Assay Accurately weigh about 500 mg of Biperiden Hydrochloride, and dissolve in 80 mL of glacial acetic acid, warming slightly, if necessary, to effect solution. Cool, add 1 drop of crystal violet TS and 10 mL of mercuric acetate 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 34.79 mg of C21H29NO·HCl.
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USP35NF30 Page 2363