INTRODUCTION
Colchicine is a naturally occurring alkaloid obtained primarily from the autumn crocus (Colchicum autumnale) and related species. It has been used in medicine for centuries, especially for the treatment of gout and Familial Mediterranean Fever. In modern medicine, Colchicine is valued also in conditions like pericarditis, Behçet’s disease, and certain dermatological and cardiac disorders.
MANUFACTURE
- Plant Source: Primarily obtained from Colchicum autumnale corms and seeds.
- Extraction Process: Plant material is dried and powdered. Extracted with acidified water or alcohol (e.g., ethanol or methanol). Colchicine is then isolated by solvent extraction, followed by purification via crystallization.
- Purification: May involve chromatographic techniques/solvent partitioning to improve purity.
| Synonym | 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
| Medical Applications: |
| • Gout Treatment |
| Used to relieve acute gout attacks by reducing inflammation and crystal-induced joint damage. |
| Acts by inhibiting neutrophil activity and microtubule polymerization. |
| • Familial Mediterranean Fever (FMF) |
| Colchicine is the first-line treatment to prevent and reduce flare-ups. |
| • Pericarditis |
| Used as an adjunct therapy to reduce recurrence in pericardial inflammation. |
| • Behçet’s Disease |
| Sometimes used for mucocutaneous and articular symptoms. |
| • Anti-mitotic Agent |
| Prevents spindle formation in dividing cells, thus used experimentally in cancer and cytogenetic research. |
| Research and Laboratory Applications: |
| • Mitotic Inhibitor |
| Blocks cell division at metaphase, useful in preparing karyotypes for chromosome analysis. |
| • Plant Breeding |
| Induces polyploidy (chromosome doubling) in plants to create new crop varieties with improved traits. |
SPECIFICATIONS – Ph.Eur/BP
| Test | Unit | Specification |
|---|---|---|
| Description | – | Yellowish-white amorphous or crystalline powder |
| Solubility | – | Very soluble in water, rapidly recrystallizing from concentrated solutions as the sesquihydrate, freely soluble in alcohol, practically insoluble in cyclohexane. |
| Identification | – | Should conform to IR Spectrophotometry |
| Appearance of solution | – | Solution S should be clear and not more intensely colored than reference solution GY |
| Acidity or Alkalinity | – | Should comply |
| Specific optical rotation | ° | -235 to -250 (anhydrous substance) |
| Related substance | ||
| Impurity A | % | NMT 3.5 |
| Impurity B | % | NMT 1.0 |
| Impurity C | % | NMT 1.0 |
| Impurity D | % | NMT 1.0 |
| Impurity E | % | NMT 1.0 |
| Unspecified impurities | % | NMT 0.1 |
| Total impurities | % | NMT 5.0 |
| Colchicine | % | NMT 0.2 |
| Chloroform | ppm | NMT 500 |
| Ethyl acetate | % | NMT 6.0 |
| Water content | % | NMT 2.0 |
| Sulphated ash | % | NMT 0.1 |
| Assay (anhydrous substance) | % | 97.0 to 102.0 |
| Additional test | ||
| Residual solvents | ||
| Methanol | ppm | NMT 3000 |
| Ethyl alcohol | ppm | NMT 5000 |
| Dichloromethane | ppm | NMT 600 |
| Benzene | ppm | NMT 2 |
PACKING
25 kg UN approved drum with inner packing 1 kg.
STORAGE
WHO-GMP, Written Confirmation (WC) and DMF.
CERTIFICATION
WHO-GMP, Written Confirmation (WC) and DMF.
ExSyn offers Colchicine on commercial scales and welcomes enquiries. Our exceptional quality and service will make ExSyn your supplier of choice! If you need any additional information or SDS, please contact us.
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