Chlorambucil
(klor am' bue sil).
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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USP35NF30 Page 2605
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