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.

Residual solvents 467: meet the requirements.

Assay— Weigh and finely powder not fewer than 40 Tablets. [Caution—Guard 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.

Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals

USP29–NF24 Page 326

Phone Number : 1-301-816-8320