(klor am' bue sil).
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C14H19Cl2NO2 304.21

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.
[Caution—Great 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.
USP Reference standards 11
USP Chlorambucil RS Click to View Structure
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.
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Monograph Feiwen Mao, M.S.
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(SM32010) Monographs - Small Molecules 3
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USP35–NF30 Page 2605