Chlorambucil
Benzenebutanoic acid, 4-[bis(2-chloroethyl)amino]-. 4-[p-[Bis(2-chloroethyl)amino]phenyl]butyric acid [305-03-3]. » Chlorambucil contains not less than 98.0 percent and not more than 101.0 percent of C14H19Cl2NO2, calculated on the anhydrous basis.
CautionGreat care should be taken to prevent inhaling particles of Chlorambucil and exposing the skin to it.
Packaging and storage
Preserve in tight, light-resistant containers.
Identification
A:
Infrared Absorption 197S: 1 in 125 solution, carbon disulfide, 1-mm cell.
B:
Dissolve 50 mg in 5 mL of acetone, and dilute with water to 10 mL. Add 1 drop of 2 N sulfuric acid, then add 4 drops of silver nitrate TS: no opalescence is observed immediately (absence of chloride ion). Warm the solution on a steam bath: opalescence develops (presence of ionizable chlorine).
Melting range 741:
between 65 and 69.
Water, Method I 921:
not more than 0.5%.
Assay
Dissolve about 200 mg of Chlorambucil, accurately weighed, in 10 mL of acetone, add 10 mL of water, and titrate with 0.1 N sodium hydroxide VS, using phenolphthalein TS as the indicator. Each mL of 0.1 N sodium hydroxide is equivalent to 30.42 mg of C14H19Cl2NO2.
Auxiliary Information
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Chromatographic Column
USP32NF27 Page 1884
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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