» Colchicine Injection is a sterile solution of C22H25NO6 in Water for Injection, prepared from Colchicine with the aid of Sodium Hydroxide. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C22H25NO6.
[CautionColchicine is extremely poisonous. ]
Packaging and storage Preserve in single-dose containers, preferably of Type I glass, protected from light.
USP Reference standards 11
USP Colchicine RS
USP Endotoxin RS
A: Transfer a volume of Injection, equivalent to about 2 mg of colchicine, to a separator. Add 5 mL of water, and extract with 15 mL of chloroform. Evaporate the chloroform extract, using mild heat, to dryness: the IR absorption 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 UV absorption spectrum of the Injection, diluted with water to a concentration of about 10 µg of colchicine per mL, exhibits maxima and minima at the same wavelengths as that of a similar solution of USP Colchicine RS, concomitantly measured.
Bacterial endotoxins 85 It contains not more than 166.7 USP Endotoxin Units per mg of colchicine.
pH 791: between 6.0 and 7.2, in a solution of Injection containing 1.0 mg of potassium chloride in each mL.
Other requirements It meets the requirements under Injections 1.
Assay [notePerform all dilutions in low-actinic glassware. ]
Mobile phase, Standard preparation, and Chromatographic system Prepare as directed in the Assay under Colchicine.
Assay preparation [notePrepare immediately before use. ] Transfer an accurately measured volume, V mL, of Injection, equivalent to about 1 mg of colchicine, to a 50-mL volumetric flask, dilute with a mixture of methanol and water (1:1) to volume, and mix. Pipet 30 mL of this solution into a 100-mL volumetric flask, dilute with the same mixture to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Colchicine, and measure the responses for the colchicine peaks. Calculate the quantity, in mg, of C22H25NO6 in each mL of the Injection taken by the formula:
(C / 6V)(rU / rS)in which C is the concentration, in µg per mL, of the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 2763