Pilocarpine Hydrochloride
C11H16N2O2·HCl
244.72
244.722(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.
Identification—
B:
A solution (1 in 20) responds to the tests for Chloride 
191
.
191.
Melting range 741:
between 199
and 205, but the range between beginning and end of melting does not exceed 3.
741:
between 199 and 205, but the range between beginning and end of melting does not exceed 3.
Loss on drying 731—
Dry it at 105 for 2 hours: it loses not more than 3.0% of its weight.
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.
271—
Dissolve 250 mg in 5 mL of sulfuric acid TS: the solution has no more color than Matching Fluid B.
Ordinary impurities 466—
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.
Chromatographic Column—
| 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 columns text is not derived from, and not part of, USP 32 or NF 27.