Hydroxychloroquine Sulfate
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C18H26ClN3O·H2SO4 433.95

Ethanol, 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.
A: Ultraviolet Absorption 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.
Loss on drying 731 Dry it at 105 for 2 hours: it loses not more than 2.0% of its weight.
Ordinary impurities 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 Scientist
(MDAA05) Monograph Development-Antivirals and Antimicrobials
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 2592
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.