Colchicine Injection

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 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.

[Caution-Colchicine is extremely poisonous.]

1 Packaging and storage

Preserve in single-dose containers, preferably of Type I glass, protected from light.

2 USP Reference standards 〈11〉

USP Colchicine RS

3 Identification

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.

4 BACTERIAL ENDOTOXINS TEST (85)

It contains not more than 166.7 USP Endotoxin Units per mg of colchicine.

5 PH (791)

between 6.0 and 7.2, in a solution of Injection containing 1.0 mg of potassium chloride in each mL

6 Other requirements

It meets the requirements under Injections and Implanted Drug Products (1),

7 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.] 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)(r_u/r_s)

in which C is the concentration, in 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.