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Chloroquine
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C18H26ClN3 319.87

1,4-Pentanediamine, N4-(7-chloro-4-quinolinyl)-N1,N1-diethyl-.
7-Chloro-4-[[4-(diethylamino)-1-methylbutyl]amino]quinoline [54-05-7].
» Chloroquine contains not less than 98.0 percent and not more than 102.0 percent of C18H26ClN3, calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers. Store at 25, excursions permitted between 15 and 30.
Identification—
A: Dissolve 35 mg in 4 mL of chloroform, and pass through a dry filter: the IR absorption spectrum of the solution so obtained exhibits maxima only at the same wavelengths as that of a solution of USP Chloroquine Phosphate RS prepared as directed in Identification test A under Chloroquine Phosphate.
B: Ultraviolet Absorption 197U—
Solution: 10 µg per mL.
Medium: dilute hydrochloric acid (1 in 1000).
Ratio: A343 / A329, between 1.00 and 1.15.
Melting range 741: between 87 and 92.
Loss on drying 731— Dry it at 105 for 2 hours: it loses not more than 2.0% of its weight.
Residue on ignition 281: not more than 0.2%.
Organic volatile impurities, Method V 467: meets the requirements.
Solvent— Use dimethyl sulfoxide.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 250 mg of Chloroquine, accurately weighed, in 50 mL of glacial acetic acid TS, add crystal violet TS, and titrate with 0.1 N perchloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 15.99 mg of C18H26ClN3.
Auxiliary Information— Staff Liaison : Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29–NF24 Page 480
Pharmacopeial Forum : Volume No. 29(6) Page 1859
Phone Number : 1-301-816-8394