Chloroquine
;)
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 98.0percent and not more than 102.0percent of C18H26ClN3,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.Store at 25
,excursions permitted between 15and 30.
,excursions permitted between 15and 30.
Identification—
A:
Dissolve 35mg in 4mLof chloroform,and pass through a dry filter:the IRabsorption spectrum of the solution so obtained exhibits maxima only at the same wavelengths as that of a solution of USP Chloroquine Phosphate RSprepared as directed in Identificationtest Aunder Chloroquine Phosphate.
B:Ultraviolet Absorption á197Uñ—
Solution:
10µg per mL.
Medium:
dilute hydrochloric acid (1in 1000).
Ratio:
A343/A329,between 1.00and 1.15.
Loss on drying á731ñ—
Dry it at 105for 2hours:it loses not more than 2.0%of its weight.
for 2hours:it loses not more than 2.0%of its weight.
Residue on ignition á281ñ:
not more than 0.2%.
Organic volatile impurities,Method Vá467ñ:
meets the requirements.
Solvent—
Use dimethyl sulfoxide.
Assay—
Dissolve about 250mg of Chloroquine,accurately weighed,in 50mLof glacial acetic acid TS,add crystal violet TS,and titrate with 0.1Nperchloric acid VS.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 15.99mg of C18H26ClN3.
Auxiliary Information—
Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 444
Pharmacopeial Forum:Volume No.29(6)Page 1859
Phone Number:1-301-816-8394