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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 98.5 percent and not more than 101.0 percent of C11H16N2O2·NO3, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers.
Identification—
B: Mix a solution (1 in 10) with an equal volume of ferrous sulfate TS, and superimpose the mixture upon 5 mL of sulfuric acid contained in a test tube: the zone of contact becomes brown.
Melting range 741: between 171 and 176, with decomposition, but the range between beginning and end of melting does not exceed 3.
Specific rotation 781S: between +79.5 and +82.5.
Test solution: 20 mg per mL, in water.
Loss on drying 731 Dry it at 105 for 2 hours: it loses not more than 2.0% of its weight.
Readily carbonizable substances 271 Dissolve 100 mg in 5 mL of sulfuric acid TS: the solution has no more color than Matching Fluid A.
Chloride— To 5 mL of a solution (1 in 50), acidified with nitric acid, add a few drops of silver nitrate TS: no opalescence is produced immediately.
Other alkaloids— Dissolve 200 mg in 20 mL of water, and divide the solution into two portions. To one portion add a few drops of 6 N ammonium hydroxide and to the other add a few drops of potassium dichromate TS: no turbidity is produced in either solution.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 600 mg of Pilocarpine Nitrate, accurately weighed, in 30 mL of glacial acetic acid, warming slightly to effect solution. Cool to room temperature, and titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 27.13 mg of C11H16N2O2·NO3.
Auxiliary Information— Staff Liaison : Feiwen Mao, M.S., Senior Scientific Associate
Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
USP29–NF24 Page 1735
Phone Number : 1-301-816-8320