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.
| Synonyms | N-[(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 formula | C22H25NO6 |
| Molecular weight | 399.44 |
| Structure |  |
Applications
| Gout and Pseudogout | Colchicine 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 Fever | Colchicine has been the treatment of choice for Familial Mediterranean Fever (FMF) a hereditary autoinflammatory condition since the 1970’s. |
| Uses in Dermatology | Colchicine 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 Indications | The 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
| Test | Unit | Specification |
|---|---|---|
| Appearance | – | Yellowish-White, amorphous or crystalline powder |
| Solubility | – | Very 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 solution | – | Solution S is clear (2.2.1) and not more intensely coloured than reference solution GY3 (2.2.2, Method II) |
| Acidity or Alkalinity | – | Either 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 ash | – | Max 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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