A:Infrared Absorption á197Kñ— Obtain the test specimen as follows.Remove as completely as possible the contents of 5Capsules,and dissolve,with shaking,in 10mLof chloroform.Filter,and evaporate the chloroform solution to dryness.Proceed as directed with the dry residue so obtained and USP Altretamine RS.

B: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.

Medium: 0.1Nhydrochloric acid;900mL.

Apparatus 1: 100rpm.

Time: 30minutes.

Procedure— Determine the amount of C9H18N6dissolved from UVabsorbances at 242nm on filtered portions of the solution under test,suitably diluted if necessary with Dissolution Medium,in comparison with a Standard solution having a known concentration of USP Altretamine RSin the same Medium.

Tolerances— Not less than 80%(Q)of the labeled amount of C9H18N6is dissolved in 30minutes.

Buffer solution,Diluent,Mobile phase,Standard preparation,and Chromatographic system— Prepare as directed in Altretamine.

Assay preparation— Remove as completely as possible the contents of not fewer than 20Capsules,and weigh accurately.Mix the combined contents,and transfer as completely as possible to a 500-mLvolumetric flask.Add 325mLof methanol,and sonicate.Dilute with water to volume,and mix.Transfer an accurately measured volume of this solution,equivalent to about 10mg of altretamine,to a 200-mLvolumetric flask,dilute with Diluentto volume,and mix.

Procedure— Separately inject equal volumes (about 10µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of altretamine (C9H18N6)in the portion of Capsules taken by the formula: in which Cis the concentration,in mg per mL,of USP Altretamine RSin the Standard preparation;and rUand rSare the altretamine peak responses obtained from the Assay preparationand the Standard preparation,respectively.