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 Identificationtests under Busulfan,and melts at about 115.

Disintegration á701ñ: 30minutes,the use of disks being omitted.

Uniformity of dosage units á905ñ: meet the requirements.

Assay— Weigh and finely powder not fewer than 40Tablets.[Caution—Guard against accidental inhalation of fine powder. ]Weigh accurately a portion of the powder,equivalent to about 80mg of busulfan,and transfer to a 100-mLbeaker.Extract with four 20-mLportions 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-mLconical flask.Evaporate the combined acetone extracts to about 10mL,add phenolphthalein TS,and neutralize with 0.05Nsodium hydroxide.Evaporate to dryness,add about 30mLof water,and proceed as directed in the Assayunder Busulfan,beginning with “Connect the flask.”Each mLof 0.05Nsodium hydroxide is equivalent to 6.158mg of C6H14O6S2.

Expert Committee:(PA6)Pharmaceutical Analysis 6

USP28–NF23Page 300

Phone Number:1-301-816-8389