A: Transfer a volume of Injection,equivalent to about 2mg of colchicine,to a separator.Add 5mLof water,and extract with 15mLof chloroform.Evaporate the chloroform extract,using mild heat,to dryness:the IRabsorption spectrum of a potassium bromide dispersion of the residue so obtained exhibits maxima only at the same wavelengths as that of a similar preparation of USP Colchicine RS.

B: The UVabsorption spectrum of the Injection,diluted with water to a concentration of about 10µg of colchicine per mL,exhibits maxima and minima at the same wavelengths as that of a similar solution of USP Colchicine RS,concomitantly measured.

Mobile phase,Standard preparation,and Chromatographic system— Prepare as directed in the Assayunder Colchicine.

Assay preparation— [NOTE—Prepare immediately before use.]Transfer an accurately measured volume,VmL,of Injection,equivalent to about 1mg of colchicine,to a 50-mLvolumetric flask,dilute with a mixture of methanol and water (1:1)to volume,and mix.Pipet 30mLof this solution into a 100-mLvolumetric flask,dilute with the same mixture to volume,and mix.

Procedure— Proceed as directed for Procedurein the Assayunder Colchicine,and measure the responses for the colchicine peaks.Calculate the quantity,in mg,of C22H25NO6in each mLof the Injection taken by the formula: in which Cis the concentration,in µg per mL,of the Standard preparation;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.