Colchicine Tablets

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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Colchicine Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C₂₂H₂₅NO₆

1 Packaging and storage

Preserve in well-closed, light-resistant containers.

2 USP REFERENCE STANDARDS (11)

USP Colchicine RS

3 Identification

Weigh a portion of ground Tablets, equivalent to about 20 mg of colchicine, triturate with 20 mL of water, allow the solids to settle, and filter the supernatant into a separator. Extract with 30 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.

3.1 DISSOLUTION, Procedure for a Pooled Sample (711)

[NOTE-Conduct this procedure without delay, under subdued light, and using low-actinic glassware.]

Medium: water, 500 mL.

Apparatus 1: 100 rpm.

Time: 30 minutes.

Procedure-Determine the amount of C₂₂H₂₅NO₆ dissolved, employing the procedure set forth in the Assay under Colchicine, making any necessary modifications.

Tolerances-Not less than 75% (Q) of the labeled amount of C₂₂H₂₅NO₆ is dissolved in 30 minutes. 22 25

3.2 UNIFORMITY OF DOSAGE UNITS (905): meet the requirements.

4 Assay

[NOTE-Perform all dilutions in low-actinic glassware.]

Mobile phase, Standard preparation, and Chromatographic system-Prepare as directed in the Assay under Colchicine.

Assay preparation-[NOTE-Prepare immediately before use.] Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 0.6 mg of colchicine, to a 100-mL volumetric flask, add about 50 mL of a mixture of methanol and water (1:1), and shake by mechanical means for 15 minutes, rinsing down the walls of the flask at about 8 minutes. Dilute with the same mixture to volume, and pass through a 0.45-µm membrane filter.

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 the portion of Tablets taken by the formula:

0.1C(r_u/r_s)

in which C is the concentration, in µg µg per ml, of the Standard preparation; and r_u and r_s are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.