Physostigmine Sulfate
(fye'' soe stig' meen sul' fate).
(C15H21N3O2)2·H2SO4
648.77
648.77Pyrrolo[2,3-b]indol-5-ol, 1,2,3,3a,8,8a-hexahydro-1,3a,8-trimethyl-, methylcarbamate (ester), (3aS-cis)-, sulfate (2:1).
Physostigmine sulfate (2:1)
[64-47-1].» Physostigmine Sulfate contains not less than 97.0 percent and not more than 102.0 percent of (C15H21N3O2)2·H2SO4, calculated on the dried basis.
Packaging and storage—
Preserve in tight, light-resistant containers.
USP Reference standards 
11
—
11—
USP Physostigmine Salicylate RS 
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Identification—
A:
It responds to the Identification test under Physostigmine.
B:
A solution (1 in 100) responds to the tests for Sulfate 191.
191.
116
Loss on drying 731—
Dry it at 105
to constant weight: it loses not more than 1.0% of its weight.
731—
Dry it at 105 to constant weight: it loses not more than 1.0% of its weight.
Residue on ignition 281:
negligible, from 100 mg.
281:
negligible, from 100 mg.
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.
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 200 mg of Physostigmine Sulfate, accurately weighed, in 25 mL of water. Render the solution alkaline by the addition of about 1 g of sodium bicarbonate, and extract with one 25-mL and five 10-mL portions of chloroform, each time shaking vigorously for 1 minute. Filter each extract through glass wool. Add 15 mL of glacial acetic acid and 10 mL of acetic acid anhydride to the combined chloroform extracts, and titrate with 0.02 N perchloric acid 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 6.488 mg of (C15H21N3O2)2·H2SO4.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Hariram Ramanathan, M.S.
Associate Scientific Liaison 1-301-816-8313 |
(SM42010) Monographs - Small Molecules 4 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4317
Pharmacopeial Forum: Volume No. 34(5) Page 1179