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

  1. Plant Source: Primarily obtained from Colchicum autumnale corms and seeds.
  2. 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.
  3. Purification: May involve chromatographic techniques/solvent partitioning to improve purity.
SynonymN-((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

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

TestUnitSpecification
DescriptionYellowish-white amorphous or crystalline powder
SolubilityVery soluble in water, rapidly recrystallizing from concentrated solutions as the sesquihydrate, freely soluble in alcohol, practically insoluble in cyclohexane.
IdentificationShould conform to IR Spectrophotometry
Appearance of solutionSolution S should be clear and not more intensely colored than reference solution GY
Acidity or AlkalinityShould 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
ChloroformppmNMT 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
MethanolppmNMT 3000
Ethyl alcoholppmNMT 5000
DichloromethaneppmNMT 600
BenzeneppmNMT 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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