Biperiden
;)
1-Piperidinepropanol,a-bicyclo[2.2.1]hept-5-en-2-yl-a-phenyl-.
a-5-Norbornen-2-yl-a-phenyl-1-piperidinepropanol [514-65-8].
»Biperiden contains not less than 98.0percent and not more than 101.0percent of C21H29NO,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed,light-resistant containers.
Identification—
A:
Infrared Absorption á197Kñ.
Solution
:900mg per mL.Transfer about 180mg of it,accurately weighed,to a 200-mLvolumetric flask,add 1mLof lactic acid,dilute with water to volume,and mix.Absorptivities,at about 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:
Dissolve 200mg in 80mLof water with the aid of 0.5mLof 3Nhydrochloric acid,warming,if necessary,to effect solution,and then cool.To 5mLof the solution add 1drop of hydrochloric acid and several drops of mercuric chloride TS:a white precipitate is formed.To a second 5-mLportion of the solution add bromine TSdropwise:a yellow precipitate forms which redissolves on shaking,and finally,upon the addition of more bromine TS,a permanent precipitate is formed.
Loss on drying á731ñ—
Dry it at 105
for 3hours:it loses not more than 1.0%of its weight.
for 3hours:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
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—
Dissolve about 500mg of Biperiden,accurately weighed,in 20mLof benzene,add 2drops of crystal violet 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 31.15mg of C21H29NO.
Auxiliary Information—
Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 260
Pharmacopeial Forum:Volume No.29(6)Page 1851
Phone Number:1-301-816-8165