Physostigmine Salicylate
(fye'' soe stig' meen sa lis' i late).
C15H21N3O2·C7H6O3
413.47
Pyrrolo[2,3-b]indol-5-ol, 1,2,3,3a,8,8a-hexahydro-1,3a,8-trimethyl-, methylcarbamate (ester), (3aS-cis)-, mono-(2-hydroxybenzoate). Physostigmine monosalicylate [57-64-7]. » Physostigmine Salicylate contains not less than 97.0 percent and not more than 102.0 percent of C15H21N3O2·C7H6O3, calculated on the dried basis.
Packaging and storage
Preserve in tight, light-resistant containers. Store at 25, excursions permitted between 15 and 30.
Identification
A:
It responds to the Identification test under Physostigmine.
B:
It responds to the tests for Salicylate 191.
Loss on drying 731
Dry it over silica gel for 24 hours: it loses not more than 1.0% of its weight.
Residue on ignition 281:
negligible, from 100 mg.
Sulfate
Precipitate the salicylic acid from 10 mL of a cold, saturated solution of Physostigmine Salicylate with a slight excess of 3 N hydrochloric acid, filter, and to the filtrate add 5 drops of barium chloride TS: no turbidity is produced immediately.
Readily carbonizable substances 271
Dissolve 100 mg in 5 mL of sulfuric acid: at the end of 5 minutes the solution has no more color than Matching Fluid I.
Assay
Dissolve about 250 mg of Physostigmine Salicylate, accurately weighed, in 25 mL of chloroform. Add 25 mL of glacial acetic acid, and titrate with 0.02 N perchloric acid in dioxane VS, determining the endpoint potentiometrically. Perform a blank determination, and make any necessary correction. Each mL of 0.02 N perchloric acid is equivalent to 8.270 mg of C15H21N3O2·C7H6O3.
Auxiliary Information
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USP35NF30 Page 4316
Pharmacopeial Forum: Volume No. 34(5) Page 1179
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