Hydroxychloroquine Sulfate
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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 98.0percent and not more than 102.0percent of C18H26ClN3O·H2SO4,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed,light-resistant containers.
Identification—
A:
Ultraviolet Absorption á197Uñ—
Solution:
10µg per mL.
Medium:
dilute hydrochloric acid (1in 100).
B:
Infrared Absorption á197Kñ.
C:
Asolution (1in 100)responds to the tests for Sulfate á191ñ.
Loss on drying á731ñ—
Dry it at 105
for 2hours:it loses not more than 2.0%of its weight.
for 2hours:it loses not more than 2.0%of its weight.
Ordinary impurities á466ñ—
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.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Dissolve about 100mg of Hydroxychloroquine Sulfate,accurately weighed,in about 5mLof water,and dilute quantitatively and stepwise with dilute hydrochloric acid (1in 100)to obtain a solution containing about 10µg 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 343nm,with a suitable spectrophotometer,using dilute hydrochloric acid (1in 100)as the blank.Calculate the quantity,in mg,of C18H26ClN3O·H2SO4in the portion of Hydroxychloroquine Sulfate taken by the formula:
10C(AU/AS),
in which Cis the concentration,in µg per mL,of USP Hydroxychloroquine Sulfate RSin the Standard solution,and AUand ASare the absorbances of the solution of Hydroxychloroquine Sulfate and the Standard solution,respectively.
Auxiliary Information—
Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 977
Phone Number:1-301-816-8394