Pilocarpine Nitrate
(pye'' loe kar' peen nye' trate).
C11H16N2O2·HNO3
271.27
271.272(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.
USP Reference standards 
11
—
11—
USP Pilocarpine Nitrate RS 
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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.
741:
between 171 and 176, with decomposition, 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 2.0% of its weight.
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 : the solution has no more color than Matching Fluid A.
271—
Dissolve 100 mg in 5 mL of sulfuric acid : 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.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Feiwen Mao, M.S.
Senior Scientific Liaison 1-301-816-8320 |
(SM32010) Monographs - Small Molecules 3 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4325
Pharmacopeial Forum: Volume No. 34(5) Page 1179