Pilocarpine Nitrate
C11H16N2O2·HNO3 271.27

2(3H)-Furanone,3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl]-,(3S-cis)-,mononitrate.
Pilocarpine mononitrate [148-72-1].
»Pilocarpine Nitrate contains not less than 98.5percent and not more than 101.0percent of C11H16N2O2·NO3,calculated on the dried basis.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification—
A: Infrared Absorption á197Kñ.
B: Mix a solution (1in 10)with an equal volume of ferrous sulfate TS,and superimpose the mixture upon 5mLof sulfuric acid contained in a test tube:the zone of contact becomes brown.
Melting range á741ñ: between 171and 176,with decomposition,but the range between beginning and end of melting does not exceed 3.
Specific rotation á781Sñ: between +79.5and +82.5.
Test solution: 20mg per mL,in water.
Loss on drying á731ñ— Dry it at 105for 2hours:it loses not more than 2.0%of its weight.
Readily carbonizable substances á271ñ— Dissolve 100mg in 5mLof sulfuric acid TS:the solution has no more color than Matching Fluid A.
Chloride— To 5mLof a solution (1in 50),acidified with nitric acid,add a few drops of silver nitrate TS:no opalescence is produced immediately.
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 600mg of Pilocarpine Nitrate,accurately weighed,in 30mLof glacial acetic acid,warming slightly to effect solution.Cool to room temperature,and titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 27.13mg of C11H16N2O2·NO3.
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
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