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 98.5 percent and not more than 101.0 percent of C11H16N2O2·HCl, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers.
B: A solution (1 in 20) responds to the tests for Chloride 191.
Melting range 741: between 199 and 205, but the range between beginning and end of melting does not exceed 3.
Specific rotation 781S: between +88.5 and +91.5.
Test solution: 20 mg per mL, in water.
Loss on drying 731 Dry it at 105 for 2 hours: it loses not more than 3.0% of its weight.
Readily carbonizable substances 271 Dissolve 250 mg in 5 mL of sulfuric acid TS: the solution has no more color than Matching Fluid B.
Ordinary impurities 466
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 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 500 mg of Pilocarpine Hydrochloride, accurately weighed, in a mixture of 20 mL of glacial acetic acid and 10 mL of mercuric acetate TS, warming slightly to effect solution. Cool the solution to room temperature, add 2 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 24.47 mg of C11H16N2O2·HCl.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Feiwen Mao, M.S.
(MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
Reference Standards Lili Wang, Technical Services Scientist
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.