Biperiden Hydrochloride
C21H29NO·HCl
347.92
1-Piperidinepropanol,a-bicyclo[2.2.1]hept-5-en-2-yl-a-phenyl-,hydrochloride.
a-5-Norbornen-2-yl-a-phenyl-1-piperidinepropanol hydrochloride [1235-82-1].
»Biperiden Hydrochloride contains not less than 98.0percent and not more than 101.0percent of C21H29NO·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed,light-resistant containers.
Identification—
A:
Infrared Absorption á197Kñ.
B:
Ultraviolet Absorption á197Uñ—
Solution:
1mg per mL.
Medium:
methanol.
Absorptivities at 257nm,calculated on the dried basis,do not differ by more than 3.0%.
C:
Dissolve about 20mg in 5mLof phosphoric acid:a green color is produced.
D:
To 5mLof a solution (1in 500)add bromine TSdropwise:a yellow precipitate,which dissolves on shaking,is formed.Addition of more bromine TSproduces a precipitate that does not dissolve on shaking.
E:
A5-mLportion of a solution (1in 500)responds to the tests for Chloride á191ñ.
Loss on drying á731ñ—
Dry it at 105
for 3hours:it loses not more than 0.5%of its weight.
for 3hours:it loses not more than 0.5%of its weight.
Ordinary impurities á466ñ—
Test solution:
methanol.
Standard solution:
methanol.
Eluant:
a mixture of methanol and ammonium hydroxide (100:1.5).
Visualization:
17.
Organic volatile impurities,Method IVá467ñ:
meets the requirements.
Assay—
Accurately weigh about 500mg of Biperiden Hydrochloride,and dissolve in 80mLof glacial acetic acid,warming slightly,if necessary,to effect solution.Cool,add 1drop of crystal violet TSand 10mLof mercuric acetate TS,and titrate with 0.1Nperchloric acid VSto a blue endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 34.79mg of C21H29NO·HCl.
Auxiliary Information—
Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 261
Phone Number:1-301-816-8165