Codeine Sulfate
(C18H21NO3)2·H2SO4·3H2O
750.85
750.85Morphinan-6-ol, 7,8-didehydro-4,5-epoxy-3-methoxy-17-methyl-, (5
,6)-, sulfate (2:1) (salt), trihydrate.
7,8-Didehydro-4,5
-epoxy-3-methoxy-17-methylmorphinan-6-ol sulfate (2:1) (salt) trihydrate
[6854-40-6].Anhydrous 696.82
[1420-53-7].» Codeine Sulfate, dried at 105
for 3 hours, contains not less than 98.5 percent and not more than 100.5 percent of (C18H21NO3)2·H2SO4.
for 3 hours, contains not less than 98.5 percent and not more than 100.5 percent of (C18H21NO3)2·H2SO4.
Packaging and storage—
Preserve in tight, light-resistant containers.
Identification—
B:
Ultraviolet Absorption 
197U
—
197U—
Solution:
100 µg per mL.
Medium:
water.
Absorptivities at 284 nm, calculated on the dried basis, do not differ by more than 3.0%.
C:
It responds to the tests for Sulfate 191.
191.
112.5
Acidity—
Dissolve 500 mg in 15 mL of water, add 1 drop of methyl red TS, and titrate with 0.020 N sodium hydroxide: not more than 0.30 mL is required for neutralization.
Water, Method III 921—
Dry about 500 mg, accurately weighed, at 105 for 3 hours: it loses between 6.0% and 7.5% of its weight.
921—
Dry about 500 mg, accurately weighed, at 105 for 3 hours: it loses between 6.0% and 7.5% of its weight.
Readily carbonizable substances 271—
Dissolve 10 mg in 5 mL of sulfuric acid TS: the solution has no more color than Matching Fluid S.
271—
Dissolve 10 mg in 5 mL of sulfuric acid TS: the solution has no more color than Matching Fluid S.
Residue on ignition 281:
not more than 0.1%.
281:
not more than 0.1%.
Limit of morphine—
Dissolve about 50 mg of potassium ferricyanide in 10 mL of water, and add 1 drop of ferric chloride TS and 1 mL of a solution of Codeine Sulfate (1 in 100): no blue color is produced immediately.
Chromatographic purity—
Using Codeine Sulfate, proceed as directed in the test for Chromatographic purity under Codeine, except to use a mixture of 0.01 N hydrochloric acid and dehydrated alcohol (4:1), instead of dehydrated alcohol, to prepare Solution A, Solution B, and Solution C.
Assay—
Dissolve about 1.4 g of Codeine Sulfate, previously dried and accurately weighed, in 50 mL of glacial acetic acid, warming, if necessary, to effect solution. 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 69.68 mg of (C18H21NO3)2·H2SO4.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Clydewyn M. Anthony, Ph.D.
Scientist 1-301-816-8139 |
(MDCCA05) Monograph Development-Cough Cold and Analgesics |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
USP32–NF27 Page 2016
Pharmacopeial Forum: Volume No. 34(5) Page 1151