» Busulfan Tablets contain not less than 93.0 percent and not more than 107.0 percent of the labeled amount of C6H14O6S2.
Packaging and storage Preserve in well-closed containers.
Identification Pulverize a suitable number of Tablets, and extract the powder with several portions of acetone. Evaporate the combined acetone extracts, with the aid of a current of air, on a steam bath: the dry residue responds to the Identification tests under Busulfan, and melts at about 115.
Disintegration 701: 30 minutes, the use of disks being omitted.
Uniformity of dosage units 905: meet the requirements.
Assay Weigh and finely powder not fewer than 40 Tablets. [CautionGuard against accidental inhalation of fine powder. ] Weigh accurately a portion of the powder, equivalent to about 80 mg of busulfan, and transfer to a 100-mL beaker. Extract with four 20-mL portions of acetone, each time stirring the mixture well, then allowing the insoluble matter to settle, and finally decanting the supernatant through a sintered-glass filter into a 250-mL conical flask. Evaporate the combined acetone extracts to about 10 mL, add phenolphthalein TS, and neutralize with 0.05 N sodium hydroxide. Evaporate to dryness, add about 30 mL of water, and proceed as directed in the Assay under Busulfan, beginning with Connect the flask. Each mL of 0.05 N sodium hydroxide is equivalent to 6.158 mg of C6H14O6S2.
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USP35NF30 Page 2410