Biperiden Hydrochloride
C21H29NO·HCl
347.92
347.921-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.
Identification—
B:
Ultraviolet Absorption 
197U
—
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.
191.
Loss on drying 731—
Dry it at 105
for 3 hours: it loses not more than 0.5% of its weight.
731—
Dry it at 105 for 3 hours: it loses not more than 0.5% of its weight.
Ordinary impurities 466—
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.
Chromatographic Column—
| Topic/Question | Contact | Expert Committee |
| Monograph | Ravi Ravichandran, Ph.D.
Senior Scientist 1-301-816-8330 |
(MDPP05) Monograph Development-Psychiatrics and Psychoactives |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
USP32–NF27 Page 1680
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.