Biperiden Hydrochloride
C21H29NO·HCl 347.92

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.
B: Ultraviolet Absorption 197U
Solution: 1 mg per mL.
Medium: methanol.
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).
Visualization: 17.
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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Senior Scientist
(MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 1680
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.