INTRODUCTION

Colchicine belongs to a class of drugs called Uricosuric agents.
It is an alkaloid used in the symptomatic relief of pain in attacks of gouty arthritis, pseudogout, sarcodial arthritis, calcific tendinitis and to treat the inflammatory symptoms of Familial Mediterranean Fever.
It appears as odourless or nearly odourless pale yellow needles or powder that darkens on exposure to light.

Manufacture
It is derived from the bulb-like corms of the Colchicum autumnale plant, also known as autumn crocus.

SynonymsN-[(7S)-1,2,3,10-Tetramethoxy-9-oxo-5,6,7,9-tetrahydrobenzo[a]heptalen-7-yl]-acetamide
CAS no.64-86-8
EINECS no.200-598-5
Molecular formulaC22H25NO6
Molecular weight399.44
Structure

Applications

Gout and PseudogoutColchicine has been known as a treatment for gout for several millenia. It is also recommended for the treatment of acute flares, as well as flare prophylaxis, in patients with pseudogout or calcium pyrophosphate crystal arthritis.
Familial Mediterranean FeverColchicine has been the treatment of choice for Familial Mediterranean Fever (FMF) a hereditary autoinflammatory condition  since the 1970’s.
Uses in DermatologyColchicine has been reported to be an efficacious and well-tolerated treatment for numerous dermatologic diseases. Behçet’s disease, epidermolysis bullosa acquisita, leukocytocastic vasculitis, Sweet’s syndrome and recurrent apthous stomatitis are some of the few dermatologic diseases in which treatment with colchicine has been studied.
New Potential IndicationsThe potential uses of colchicine have broadened significantly over the last few years as new studies have emerged demonstrating novel applications within oncology, immunology, cardiology, and dermatology.

SPECIFICATIONS – EP/BP

TestUnitSpecification
AppearanceYellowish-White, amorphous or crystalline powder
SolubilityVery soluble in wáter, rapidly re-crystallizing from concentrated solutions as the sesquihydrate, freely soluble in Ethanol (96%), practically insoluble in Cyclohexane
Identification
1. By UV

2. By IR

3. By Chemical
4. By Chemical







The ratio of absorbance measured at 243 nm to that measured 350 nm is 1.7 to 1.9

The IR absorption spectrum of the preparation of the test specimen and working standard, exhibits maxima only at the same wave lengths
The organic layer is greenish-yellow
A brownish-red colour develops
Appearance of solutionSolution S is clear (2.2.1) and not more intensely coloured than reference solution GY3 (2.2.2, Method II)
Acidity or AlkalinityEither the solution does not change colour or it become green. Not more tan 0.1 ml of 0.01 M Sodium hydroxide is required to change the colour of the indicator to blue
Specific optical rotation-250° to -235°, calculated on the anhydrous substance
Related substances (by HPLC)
1. Impurity ‘A’
2. Impurity ‘G’
3. Impurity ‘E’
4. Unspecified impurities
5. Total impurities


%
%
%
%
%


Max 3.0
Max 0.25
Max 0.20
Max 0.10
Max 4.0
Impurity F%Max 0.2
Ethyl acetate (by GC)%Max 6.0
Water content (by KF)%Max 2.0% determined on 0.500 gm
Sulphated ashMax 0.1% determined on 0.500 gm
Residual solvents (by HSGC)
1. Methanol
2. Acetone
3. Methylene Dichloride
4. Chloroform


ppm
ppm
ppm
ppm


NMT 3000
NMT 5000
NMT 600
NMT 500
Assay (Potentiometer)%97.0 to 102.0

STORAGE
Store in a dry and well-ventilated area.

PACKING
1 kg aluminum foil in steel container.

REGISTRATION / CERTIFICATION
ISO, WHO-GMP, Written Confirmation (WC), DMF as per EP/BP/USP & Certificate of Suitability (CEP) to European monograph.

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