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.
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.
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Topic/Question Contact Expert Committee
Monograph Feiwen Mao, M.S.
Scientist
1-301-816-8320
(MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
USP32–NF27 Page 3306
Pharmacopeial Forum: Volume No. 34(5) Page 1179
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.