Eucatropine Hydrochloride
;)
Benzeneacetic acid,a-hydroxy-,1,2,2,6-tetramethyl-4-piperidinyl ester hydrochloride.
1,2,2,6-Tetramethyl-4-piperidyl mandelate hydrochloride [536-93-6].
»Eucatropine Hydrochloride contains not less than 99.0percent and not more than 100.5percent of C17H25NO3·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
Identification—
A:
Dissolve about 50mg in 5mLof water,render the solution alkaline with 6Nammonium hydroxide,and extract with two 10-mLportions of ether.Evaporate the ether on a steam bath,and recrystallize the residue from solvent hexane:the eucatropine base so obtained melts between 111
and 114.
and 114.
B:
Asolution of it responds to the tests for Chloride á191ñ.
Loss on drying á731ñ—
Dry it over silica gel for 4hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Weigh accurately about 500mg of Eucatropine Hydrochloride,and dissolve it in 10mLof water.Saturate the solution with sodium chloride.Render it alkaline with 6Nammonium hydroxide,and extract the base completely with successive 15-mLportions of ether.Wash the combined ether extracts with 10mLof water,and extract the water washing with 10mLof ether.To the combined ether solutions add 25.0mLof 0.1Nsulfuric acid VS,and stir.Heat gently until the ether is expelled,cool,add methyl red TS,and titrate the excess acid with 0.1Nsodium hydroxide VS.Each mLof 0.1Nsulfuric acid is equivalent to 32.79mg of C17H25NO3·HCl.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 804
Phone Number:1-301-816-8389