Proparacaine Hydrochloride
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Benzoic acid,3-amino-4-propoxy-,2-(diethylamino)ethyl ester,monohydrochloride.
2-(Diethylamino)ethyl 3-amino-4-propoxybenzoate monohydrochloride [5875-06-9].
»Proparacaine Hydrochloride contains not less than 97.0percent and not more than 103.0percent of C16H26N2O3·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.
Identification—
A:
It meets the requirements under Identification—Organic Nitrogenous Bases á181ñ.
B:
Dissolve 50mg,accurately weighed,in water to make 250.0mL,and mix.Pipet 10mLof this solution into a 100-mLvolumetric flask,add 2mLof 10percent,pH6.0phosphate buffer (see Buffer Solutionsin the section Reagents,Indicators,and Solutions),add water to volume,and mix:the UVabsorption spectrum of the solution exhibits maxima and minima at the same wavelengths as that of a similar solution of USP Proparacaine Hydrochloride RS,concomitantly measured,and the respective absorptivities,calculated on the dried basis,at the wavelength of maximum absorbance at about 310nm do not differ by more than 3.0%.
C:
Asolution (1in 50)responds to the tests for Chloride á191ñ,the procedure for alkaloidal hydrochlorides being used.
Melting range á741ñ:
between 178
and 185,but the range between beginning and end of melting does not exceed 2.
and 185,but the range between beginning and end of melting does not exceed 2.
Loss on drying á731ñ—
Dry it at 105for 3hours:it loses not more than 0.5%of its weight.
for 3hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.15%.
Ordinary impurities á466ñ—
Test solution:
methanol.
Standard solution:
methanol.
Eluant:
a mixture of butyl alcohol,water,and glacial acetic acid (5:3:1).
Visualization:
1;17.
Assay—
Place 250mg of Proparacaine Hydrochloride,accurately weighed,in a 250-mLconical flask,add 80mLof a 1in 20solution of acetic anhydride in glacial acetic acid,and heat on a steam bath for 10minutes.Cool to room temperature,add 10mLof mercuric acetate TSand 1or 2drops of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a blue-green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 33.09mg of C16H26N2O3·HCl.
Auxiliary Information—
Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1646
Phone Number:1-301-816-8379