Pilocarpine Hydrochloride
C11H16N2O2·HCl
244.72
2(3H)-Furanone,3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl]-,monohydrochloride,(3S-cis)-.
Pilocarpine monohydrochloride [54-71-7].
»Pilocarpine Hydrochloride contains not less than 98.5percent and not more than 101.0percent of C11H16N2O2·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
Identification—
A:
Infrared Absorption á197Mñ.
B:
Asolution (1in 20)responds to the tests for Chloride á191ñ.
Melting range á741ñ:
between 199
and 205,but the range between beginning and end of melting does not exceed 3.
and 205,but the range between beginning and end of melting does not exceed 3.
Specific rotation á781Sñ:
between +88.5and +91.5.
and +91.5.
Test solution:
20mg per mL,in water.
Loss on drying á731ñ—
Dry it at 105for 2hours:it loses not more than 3.0%of its weight.
for 2hours:it loses not more than 3.0%of its weight.
Readily carbonizable substances á271ñ—
Dissolve 250mg in 5mLof sulfuric acid TS:the solution has no more color than Matching Fluid B.
Ordinary impurities á466ñ—
Test solution:
dehydrated alcohol.
Standard solution:
dehydrated alcohol.
Eluant:
a mixture of hexanes,dehydrated alcohol,and ammonium hydroxide (70:30:1).
Visualization:
17.
Limits:
not more than 1%.
Other alkaloids—
Dissolve 200mg in 20mLof water,and divide the solution into two portions.To one portion add a few drops of 6Nammonium hydroxide,and to the other add a few drops of potassium dichromate TS:no turbidity is produced in either solution.
Assay—
Dissolve about 500mg of Pilocarpine Hydrochloride,accurately weighed,in a mixture of 20mLof glacial acetic acid and 10mLof mercuric acetate TS,warming slightly to effect solution.Cool the solution to room temperature,add 2drops of crystal violet TS,and titrate with 0.1Nperchloric acid VS.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 24.47mg of C11H16N2O2·HCl.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 1561
Phone Number:1-301-816-8389