Colchicine
,

Colchicine

Colchicine Powder (High-Purity) for Pharmaceutical Formulations – Global Bulk Supply

  1. English Name: Colchicine
  1. Specification
    • Purity: Colchicine ≥ 99.0% (HPLC); high – purity grade: ≥ 99.5% (HPLC)
    • Solubility: Sparingly soluble in water (0.2 g/100 mL at 25°C), soluble in ethanol, chloroform, and ether
    • Appearance – related: Loss on drying ≤ 0.5%, heavy metals ≤ 10 ppm, residual solvents ≤ 0.5%
    • Particle Size: Standard powder ≤ 100 μm; micronized powder ≤ 5 μm for better dissolution and bioavailability
  1. Appearance
    • White to yellowish – white crystalline powder, odorless, with a bitter taste
  1. CAS NO.：64-86-8
  1. Lead time: 7 – 10 Working Days
  1. Package
    • 500 mg/vial (sterile glass vial), sealed; 10 g/aluminum foil – lined bag for research – grade products
  1. Main Market: Global pharmaceutical market, especially in North America, Europe, Asia, and the Middle East, used in the treatment of various medical conditions and research
  1. Application Scenarios

Core Properties

  • Molecular Formula: C₂₂H₂₅NO₆
  • Chemical Structure: An alkaloid with a unique structure consisting of a benzene ring, a tropolone ring, and a seven – membered ring. It contains an amide group and several methoxy groups.
  • Key Features
    • Microtubule Inhibitor: Binds to tubulin, preventing its polymerization into microtubules. This disrupts cell division, especially in rapidly dividing cells, by interfering with the formation of the mitotic spindle.
    • Anti – inflammatory: Inhibits the activation of neutrophils and reduces the production of inflammatory cytokines, making it effective in treating inflammatory conditions.
    • Low Therapeutic Index: The margin between the effective dose and the toxic dose is narrow, requiring strict dosage control to avoid severe side effects.
    • Biotransformation: Metabolized in the liver and excreted mainly through the kidneys, with some excretion in the bile.

Application Scenarios

1. Medical Treatment

  • Gout Management:
    • A first – line treatment for acute gout attacks. It reduces inflammation and pain by inhibiting the migration of neutrophils to the affected joints, providing relief within 12 – 24 hours. Usually administered at an initial dose of 1.2 mg, followed by 0.6 mg every 1 – 2 hours until symptoms improve or side effects occur.
  • Familial Mediterranean Fever (FMF):
    • Used prophylactically to prevent recurrent episodes of fever, serositis, and arthritis in patients with FMF. Daily doses of 0.5 – 2 mg are typically prescribed, reducing the frequency and severity of attacks.
  • Other Inflammatory Conditions:
    • Investigated and used off – label for treating pericarditis, Behçet’s disease, and scleroderma – related symptoms due to its anti – inflammatory properties. In pericarditis, it can reduce the recurrence rate when combined with conventional treatments.

2. Biomedical Research

  • Cell Biology Studies:
    • Serves as a valuable tool to study microtubule – dependent processes such as cell division, intracellular transport, and cell motility. By disrupting microtubule formation, researchers can observe the impact on various cellular functions and signaling pathways.
  • Cancer Research:
    • Although not commonly used as a primary cancer treatment due to its high toxicity, it is studied in the context of cancer biology to understand the role of microtubules in tumor growth and metastasis. It can also be used to induce polyploidy in cells for genetic research.
  • Drug Development:
    • Used as a reference compound for developing novel microtubule – targeting drugs. Its structure and mechanism of action inspire the design of analogs with improved therapeutic indices, reduced toxicity, and enhanced selectivity for cancer cells or inflammatory cells.

Detection Methods

  • High – Performance Liquid Chromatography (HPLC):
    • Column: C18 (250 × 4.6 mm, 5 μm), Mobile Phase: Acetonitrile – 0.1% formic acid (40:60 v/v), Flow Rate: 1.0 mL/min, Detection Wavelength: 254 nm for quantification.
  • Liquid Chromatography – Mass Spectrometry (LC – MS):
    • Employed for identifying colchicine and its metabolites in biological samples with high sensitivity. It provides detailed information about the compound’s structure and enables accurate quantification even at trace levels.
  • Thin – Layer Chromatography (TLC):
    • Used as a quick screening method for the identification of colchicine in bulk samples or during the initial stages of quality control. The sample is spotted on a silica gel plate and developed with a suitable solvent system, and the spots are visualized under UV light.

Source & Advantages

  • Natural Source: Originally isolated from the autumn crocus (Colchicum autumnale) and other Colchicum species. Today, it is also synthesized chemically to meet the global demand.
  • Therapeutic Significance: A long – established treatment for gout and FMF, providing effective relief and management of these chronic conditions.
  • Research Utility: Facilitates fundamental research in multiple fields, helping to advance our understanding of cellular processes, inflammation, and cancer mechanisms.

Regulatory Compliance

  • US FDA: Approved for the treatment of gout and FMF, strictly regulated under the Federal Food, Drug, and Cosmetic Act. Stringent manufacturing, labeling, and safety standards are enforced to ensure the quality and efficacy of colchicine – based products.
  • EMA (European Medicines Agency): Licensed for use in the treatment of gout and FMF, with continuous pharmacovigilance programs to monitor adverse effects and ensure patient safety.
  • China NMPA: Registered for clinical use in the treatment of relevant diseases, subject to Good Manufacturing Practice (GMP) requirements and regular quality inspections to comply with national pharmaceutical standards.
Categories: ,

Colchicine (API Grade) — High-Purity Active Ingredient for Pharmaceutical Applications

Colchicine remains one of the most important alkaloids used in modern medicine—widely known for its role in gout therapy, inflammation modulation, cell-division inhibition, and specialized research applications. At AIHerba® (Shaanxi Zhonghong Investment Technology Co., Ltd.), we produce pharmaceutical-grade Colchicine under strict GMP-certified systems, ensuring consistency, traceability, and regulatory compliance for global manufacturers.

With more than 28 years of extraction, purification, and pharmaceutical ingredient R&D, our factory supplies bulk Colchicine powder to pharmaceutical formulators, research institutions, and nutraceutical developers who require validated purity and dependable lot-to-lot performance.

Whether you’re searching for a Colchicine supplier, evaluating a new API manufacturer, or comparing wholesale specifications and price, this page provides everything needed to make an informed sourcing decision.

1. What Is Colchicine? (Product Overview)

Colchicine is a naturally occurring alkaloid originally isolated from Colchicum autumnale (Autumn Crocus). Today, it is produced through advanced extraction and multi-step purification processes to meet global pharmaceutical standards.

Key characteristics:

  • CAS No.: 64-86-8

  • Molecular Formula: C₂₂H₂₅NO₆

  • Appearance: White to off-white crystalline powder

  • Purity: 98%–99% (HPLC)

  • Grade: Pharmaceutical / API

Colchicine is known for its ability to:

  • Inhibit microtubule polymerization

  • Reduce inflammatory response

  • Lower neutrophil activity

  • Slow cell proliferation

2. Source & Botanical Origin

Colchicine has traditionally been sourced from:

  • Colchicum autumnale (primary botanical source)

  • Colchicum luteum

  • Gloriosa superba (used in some extraction processes globally)

At AIHerba®, we use controlled, traceable botanical raw materials, supported by pesticide monitoring and heavy-metal compliance.

3. Mechanisms of Action & Key Benefits

Validated Pharmacological Actions

(1) Anti-Inflammatory Activity
Colchicine decreases neutrophil migration and inflammatory cytokines, making it widely used in acute gout and familial Mediterranean fever (FMF).

(2) Microtubule Inhibition
It disrupts microtubule assembly, providing applications in cell biology, chromosomal research, and oncology studies.

(3) Cardiac & Vascular Applications
Recent trials explore colchicine in atherosclerosis, post-MI inflammation, and pericarditis.

(4) Potential Antiviral and Anti-Fibrotic Effects
Emerging evidence suggests regulatory effects on cytokine storms and fibrosis pathways.

Health-Related Advantages

  • Helps relieve joint pain & swelling

  • Supports cardiovascular inflammation management (supervised medical use)

  • Used in regulated prescription medications

  • Valuable in molecular biology and cytogenetic analysis

4. Traditional Uses

Historically, extracts containing colchicine were used for:

  • Painful inflammatory conditions

  • Swelling and gout

  • Edema and “heat” symptoms in Greek and Middle Eastern medicine

  • Botanical research to induce polyploidy in plants

5. Recommended Usage (For Manufacturers Only)

⚠ Colchicine is an API and prescription-controlled ingredient. End-users must follow local medical regulations.

Typical pharmaceutical manufacturing uses:

  • Oral tablets / capsules

  • Injectables (where legally approved)

  • Topical formulations (clinical)

  • Research reagents

Typical API inclusion levels range from 0.5 mg – 1.5 mg per dosage unit, depending on regulatory requirements.

6. Best Formulation Practices

For formulators developing new products:

  • Use microcrystalline cellulose or mannitol to stabilize dosage units

  • Pair with enteric coatings for reduced gastrointestinal irritation

  • Maintain anhydrous conditions to protect stability

  • Ensure HPLC fingerprint consistency across batches

7. Certificate of Analysis (COA) – Typical Specifications

1) General Specs

Item Specification Method
Appearance White to off-white powder Visual
Purity ≥ 98% HPLC
Identification Conforms HPLC/IR
Residue on Ignition ≤ 0.5% USP
Loss on Drying ≤ 1.0% USP
Assay 98%–102% HPLC

2) Pesticide Residue Panel

Pesticide Item Limit Method
Organochlorine pesticides ≤ 0.1 mg/kg GC-MS
Organophosphorus pesticides ≤ 0.2 mg/kg GC-MS
Pyrethroids ≤ 0.2 mg/kg GC-MS
Carbamates ≤ 0.1 mg/kg LC-MS/MS

3) Heavy Metals Panel

Heavy Metal Item Limit Method
Lead (Pb) ≤ 2.0 ppm ICP-MS
Arsenic (As) ≤ 1.0 ppm ICP-MS
Cadmium (Cd) ≤ 1.0 ppm ICP-MS
Mercury (Hg) ≤ 0.1 ppm ICP-MS
Total Heavy Metals ≤ 10 ppm USP <231>

4) Microbiological Profile

Microorganism Limit Method
Total Plate Count < 1,000 CFU/g USP
Yeast & Mold < 100 CFU/g USP
E. coli Negative USP
Salmonella Negative USP
Staphylococcus aureus Negative USP
Pseudomonas aeruginosa Negative USP

8. Production Technology

Our GMP plant integrates:

  • Botanical extraction

  • Solvent purification

  • Fractional crystallization

  • HPLC refinement

  • Low-temperature drying

  • Final sterile milling and sieving

Production Flow (Simplified)

Raw Materials → Solvent Extraction → Purification → Crystallization → Filtration → Drying → Milling → Sieving → QC Testing → Packaging → Final Release

9. Packaging, Storage & Shelf Life

Packaging Options

  • 1 kg aluminum foil bag

  • 5 kg / 10 kg vacuum-sealed drum

  • 25 kg fiber drum (standard export)

Storage Requirements

  • Store in a cool, dry place

  • Protect from light and heat

  • Temperature below 25°C recommended

Shelf Life

  • 24–36 months unopened

10. Sample Policy, MOQ & Logistics

  • Free sample (≤10 g) available for testing — ideal for buyers evaluating herbal extract quality or creating customized herbal extract formulations

  • MOQ: 1 kg

  • Lead Time: 3–7 days

  • Shipping: DHL, FedEx, UPS, air freight, or sea freight

  • Export documents: COA, MSDS, TDS, GMP certificates, commercial invoice

11. Industries & Applications

Primary Industries

  • Pharmaceutical manufacturers

  • Biotechnology companies

  • Research laboratories

  • Cytogenetic and plant-science institutions

Application Scenarios

  • Prescription drug production

  • Anti-inflammatory formulations

  • Gout medications

  • Cardiovascular inflammation therapy research

  • Chromosomal doubling in plants (controlled scientific use)

12. Why Choose AIHerba® as Your Colchicine Supplier?

  1. 28+ years of extraction + pharmaceutical purification experience

  2. GMP-certified production line and validated analytical methods

  3. Global customers across pharma, biotech, and research industries

  4. Traceable botanical sourcing with full documentation

  5. Strong R&D capability for customized herbal extract solutions

  6. Fast production, fast delivery, and stable bulk capacity

  7. Transparent communication + expert technical support

  8. Trusted China manufacturer with competitive wholesale options

Contact:
📧 sales@aiherba.com | info@aiherba.com | liaodaohai@gmail.com
🌐 www.aiherba.com

13. FAQ (Expert-level)

Q1. Is your Colchicine compliant with international pharmacopeias?
Yes. We produce according to USP / EP / ChP requirements and provide supporting test data.

Q2. Can I request a customized specification?
Absolutely. We support tailored purity levels, particle sizes, and packaging.

Q3. Is Colchicine stable in tablet formulations?
Yes—when stored in low-moisture conditions and paired with appropriate excipients.

Q4. Can you provide real batch COA and chromatograms?
Yes, upon request we share HPLC fingerprints, MS data, and QC reports.

Q5. Do you support contract manufacturing (OEM / ODM)?
Yes, especially for pharmaceutical intermediates and functional formulation projects.

14. Scientific References (PubMed, NIH, FDA)

  1. Terkeltaub R. Colchicine update: 2022. Arthritis Rheum.

  2. FDA Drug Database – Colchicine.

  3. NIH – National Library of Medicine: Colchicine pharmacology.

  4. Crittenden DB, et al. Colchicine and cardiovascular inflammation.

  5. PubMed: Microtubule disruption and colchicine mechanisms.

Please enable JavaScript in your browser to complete this form.

Related products

Scroll to Top

Get a Quote & Sample

Please enable JavaScript in your browser to complete this form.

Get a Quote & Sample

Call Chat Email