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Chloroquine Phosphate
C18H26ClN3·2H3PO4 515.86

1,4-Pentanediamine, N4-(7-chloro-4-quinolinyl)-N1,N1-diethyl-, phosphate (1:2).
7-Chloro-4-[[4-(diethylamino)-1-methylbutyl]amino]quinoline phosphate (1:2) [50-63-5].
» Chloroquine Phosphate contains not less than 98.0 percent and not more than 102.0 percent of C18H26ClN3·2H3PO4, calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers.
Identification—
A: It meets the requirements under Identification—Organic Nitrogenous Bases 181, chloroform being substituted for carbon disulfide in the test.
Solution: 10 µg per mL.
Medium: dilute hydrochloric acid (1 in 1000).
Ratio: A 343/A329, between 1.00 and 1.15.
Loss on drying 731 Dry it at 105 for 16 hours: it loses not more than 2.0% of its weight.
Organic volatile impurities, Method I 467: meets the requirements.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 100 mg of Chloroquine Phosphate, accurately weighed, in about 5 mL of water, and dilute quantitatively and stepwise with dilute hydrochloric acid (1 in 1000) to obtain a solution containing about 10 µg per mL. Similarly prepare a Standard solution of USP Chloroquine Phosphate 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 1000) as the blank. Calculate the quantity, in mg, of C18H26ClN3·2H3PO4 in the portion of Chloroquine Phosphate taken by the formula:
10C(AU / AS),
in which C is the concentration, in µg per mL, of USP Chloroquine Phosphate RS in the Standard solution; and AU and AS are the absorbances of the solution of Chloroquine Phosphate and the Standard solution, respectively.
Auxiliary Information— Staff Liaison : Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29–NF24 Page 481
Phone Number : 1-301-816-8394