Hydroxychloroquine Sulfate
(hye drox'' ee klor' oh kwin sul' fate).
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433.95Ethanol, 2-[[4-[(7-chloro-4-quinolinyl)amino]pentyl]ethyl]amino-, (±)-, sulfate (1:1) (salt).
(±)-2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino]ethanol sulfate (1:1) (salt)
[747-36-4].» Hydroxychloroquine Sulfate contains not less than 98.0 percent and not more than 102.0 percent of C18H26ClN3O·H2SO4, calculated on the dried basis.
Packaging and storage—
Preserve in well-closed, light-resistant containers.
USP Reference standards 
11
—
11—
USP Hydroxychloroquine Sulfate RS 
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Identification—
A:
Ultraviolet Absorption 197U—
197U—
Solution:
10 µg per mL.
Medium:
dilute hydrochloric acid (1 in 100).
C:
A solution (1 in 100) responds to the tests for Sulfate 191.
191.
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.
Ordinary impurities 466—
466—
Test solution:
10% water in methanol.
Standard solution:
10% water in methanol.
Eluant:
a mixture of alcohol, water, and ammonium hydroxide (80:16:4).
Visualization:
1.
Assay—
Dissolve about 100 mg of Hydroxychloroquine Sulfate, accurately weighed, in about 5 mL of water, and dilute quantitatively and stepwise with dilute hydrochloric acid (1 in 100) to obtain a solution containing about 10 µg per mL. Similarly prepare a Standard solution of USP Hydroxychloroquine Sulfate RS. Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 343 nm, with a suitable spectrophotometer, using dilute hydrochloric acid (1 in 100) as the blank. Calculate the quantity, in mg, of C18H26ClN3O·H2SO4 in the portion of Hydroxychloroquine Sulfate taken by the formula:
10C(AU / AS)
in which C is the concentration, in µg per mL, of USP Hydroxychloroquine Sulfate RS in the Standard solution; and AU and AS are the absorbances of the solution of Hydroxychloroquine Sulfate and the Standard solution, respectively.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Behnam Davani, Ph.D., M.B.A.
Senior Scientific Liaison 1-301-816-8394 |
(SM12010) Monographs - Small Molecules 1 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 3454