Digoxin

Digoxin

Digoxin (≥98%) – GMP-Certified Botanical Extract for Pharmaceutical Formulations & Global Bulk Supply

1.English Name:Digoxin Productoxin

  1. Specification
    • Purity: Digoxin ≥ 99.0% (HPLC); high – purity grade: ≥ 99.5% (HPLC)
    • Solubility: Sparingly soluble in water (0.06 g/L at 25°C), soluble in chloroform, ethanol, and dimethylformamide
    • Appearance – related: Loss on drying ≤ 1.0%, heavy metals ≤ 10 ppm, residual solvents ≤ 0.5%
    • Particle Size: Standard powder ≤ 100 μm; micronized powder ≤ 5 μm for better dissolution in pharmaceutical formulations
  2. Appearance
    • White to off – white crystalline powder, odorless
  3. CAS NO.：20830 – 75 – 5
  4. Lead time: 7 – 10 Working Days
  5. Package
    • 0.25 mg/tablet (blister pack or bottle), 10 mg/vial (sterile glass vial for injectable formulation), sealed under nitrogen
  6. Main Market: Global pharmaceutical market, with significant demand in North America, Europe, Asia, especially in cardiology departments and for the treatment of heart conditions
  7. Application Scenarios

Core Properties

  • Molecular Formula: C₄₁H₆₄O₁₄
  • Chemical Structure: A cardiac glycoside composed of a steroid nucleus (aglycone) attached to a trisaccharide (digitoxose) sugar chain.
  • Key Features
    • Inotropic Effect: Inhibits the sodium – potassium ATPase pump in cardiac muscle cells, leading to an increase in intracellular calcium levels. This enhances myocardial contractility, improving cardiac output in patients with heart failure.
    • Rate – Controlling Action: Slows the conduction velocity through the atrioventricular (AV) node, making it effective in controlling the ventricular rate in atrial fibrillation and atrial flutter.
    • Low Therapeutic Index: The margin between the therapeutic and toxic doses is narrow, requiring close monitoring of plasma levels (therapeutic range: 0.5 – 2.0 ng/mL) to avoid adverse effects.
    • Biotransformation: Metabolized primarily in the liver by cytochrome P450 enzymes, with about 60 – 80% excreted unchanged in the urine.

Application Scenarios

1. Cardiovascular Medicine

  • Chronic Heart Failure:
    • A mainstay in the treatment of mild to moderate chronic heart failure, especially in patients with reduced ejection fraction. It improves symptoms such as dyspnea and fatigue, and reduces hospitalizations. Usually prescribed at low doses (0.125 – 0.25 mg/day), with the dosage adjusted based on patient response and serum digoxin levels.
  • Atrial Fibrillation and Atrial Flutter:
    • Used to control the ventricular rate, helping to maintain a more regular and manageable heart rhythm. By slowing the conduction through the AV node, it prevents the ventricles from beating too rapidly in response to the irregular atrial contractions.
  • Supraventricular Tachycardia:
    • In some cases, employed to terminate or prevent episodes of supraventricular tachycardia by affecting the electrical conduction in the heart.

2. Clinical Research

  • Cardiac Physiology Studies:
    • Serves as a tool for researchers to study the function of the sodium – potassium ATPase pump and its role in cardiac muscle contraction and electrical activity. By manipulating digoxin levels, scientists can observe the impact on various cardiac parameters.
  • Drug Interaction Research:
    • Investigated to understand its interactions with other medications commonly used in cardiovascular patients, such as diuretics (which can increase the risk of digoxin toxicity due to potassium depletion) and certain antibiotics. This knowledge helps in optimizing drug regimens and preventing adverse drug – drug interactions.
  • Development of New Therapies:
    • Studied to inspire the development of novel inotropic agents or drugs that target the cardiac electrical system. Its mechanism of action provides insights for creating more effective and safer treatments for heart diseases.

Detection Methods

  • High – Performance Liquid Chromatography (HPLC):
    • Column: C18 (250 × 4.6 mm, 5 μm), Mobile Phase: Acetonitrile – 0.1% formic acid (25:75 v/v), Flow Rate: 1.0 mL/min, Detection Wavelength: 230 nm for quantification.
  • Immunoassay:
    • Widely used in clinical laboratories for rapid measurement of digoxin levels in serum or plasma. Methods such as fluorescence polarization immunoassay (FPIA) and chemiluminescent immunoassay (CLIA) offer high sensitivity and specificity, allowing for quick assessment of therapeutic and toxic levels.
  • Liquid Chromatography – Mass Spectrometry (LC – MS):
    • Employed for more accurate identification and quantification, especially in research settings or when dealing with complex biological samples. It can distinguish digoxin from its metabolites and other interfering substances, providing detailed information about the drug’s presence and concentration.

Source & Advantages

  • Natural Source: Originally isolated from the leaves of the foxglove plant (Digitalis lanata). However, most digoxin used today is synthetically produced to ensure consistent quality and meet the global demand.
  • Therapeutic Significance: A long – established medication in cardiology, with decades of clinical use, providing effective management of heart failure and cardiac arrhythmias, and improving the quality of life and prognosis for many patients.
  • Research Value: Facilitates fundamental research in cardiovascular physiology and pharmacology, contributing to a deeper understanding of heart function and the development of new treatment strategies.

Regulatory Compliance

  • US FDA: Approved for the treatment of heart failure and cardiac arrhythmias, strictly regulated under the Federal Food, Drug, and Cosmetic Act. Stringent manufacturing, labeling, and safety standards are enforced to ensure the quality, efficacy, and safe use of digoxin – containing products.
  • EMA (European Medicines Agency): Licensed for similar indications, with continuous pharmacovigilance programs in place to monitor adverse effects and ensure patient safety throughout the product lifecycle.
  • China NMPA: Registered for clinical use in the treatment of relevant cardiovascular conditions, subject to Good Manufacturing Practice (GMP) requirements and regular quality inspections to comply with national pharmaceutical standards.
Category:

DIGOXIN – High-Purity Botanical Extract for Pharmaceutical Applications

High-Purity Digoxin for Cardiac Applications | Trusted Supplier & Manufacturer with 28+ Years Expertise

Digoxin is a well-studied cardiac glycoside derived from Digitalis lanata. For decades, it has played a central role in cardiology research and drug development. At AIHerba® (Shaanxi Zhonghong Investment Technology Co., Ltd.), we produce ≥98% pure Digoxin through controlled extraction and purification, ensuring quality that meets international pharmacopeial standards.

As a GMP-certified manufacturer and global supplier, we provide bulk Digoxin for pharmaceutical formulators, research labs, and functional health product developers looking for a reliable, traceable, and compliant source.

1. Product Overview

Product name: Digoxin
Botanical source: Digitalis lanata
Specification: ≥98% (HPLC)
Appearance: White to off-white crystalline powder
Active compounds: Cardiac glycosides (Digoxin >98%)
Quality certifications: GMP, ISO9001, ISO22000, HACCP
Suitable industries: Pharmaceuticals, cardiology R&D, nutraceutical research, academic labs
Available forms: Raw powder / customized herbal extract formulations

2. What Digoxin Is Used For (Scientific & Clinical Context)

Although Digoxin is a prescription drug and must be used under medical supervision, formulators and researchers typically source high-purity Digoxin for:

(1) Cardiac Function Research

  • Regulation of sodium-potassium ATPase

  • Effects on contractility, heart rhythm, and electrical conduction

  • Dose–response modeling for new drug formulations

(2) Pharmacokinetic & Toxicology Studies

  • Bioavailability and tissue distribution

  • Drug–drug interaction models

(3) Standard Reference Material (SRM)

  • Used as a calibration standard in pharmaceutical labs

Expert Note:

“Digoxin remains one of the best-characterized cardiac glycosides in pharmacology. Its mechanism provides a reliable model for cardiac contractility studies and ion exchange research.”
— Dr. Helen Moore, PhD, Pharmacology Research Specialist (NIH)

3. Key Benefits for B2B Buyers

✔ Consistent ≥98% Purity (HPLC-verified)

Ensures stable performance in pharmaceutical and research applications.

✔ GMP-Certified Production

Every batch is produced in our GMP plant extract factory, ensuring compliance, safety, and traceability.

✔ Global Bulk Supply

We support bulk, lab-scale, and commercial-scale orders with competitive price and export documentation.

✔ Customizable Extract Solutions

We provide customized herbal extract services (OEM/ODM) for R&D and product development.

✔ Fast Lead Time + Free Samples

We offer free sample herbal extract options for qualifying partners.

4. How Digoxin Works (Mechanism)

Digoxin increases intracellular calcium availability by inhibiting the Na⁺/K⁺-ATPase pump, which influences:

  • Myocardial contractility

  • Electrical conduction

  • Resting membrane potentials

This mechanism is why Digoxin is widely used in controlled clinical settings.

Reference:
NIH – National Library of Medicine (PubMed)
FDA Drug Database – Digoxin monograph

5. Application Industries

Digoxin from AIHerba is suitable for:

  • Pharmaceutical drug formulations

  • Cardiology research laboratories

  • PK/PD studies in academic institutions

  • Bioassay development

  • Herbal pharmacology research

Not intended for dietary supplement end-products without regulatory approval.

6. Recommended Usage (For B2B Buyers, Not Medical Advice)

  • Use Digoxin only in regulated research, R&D, or pharmaceutical manufacturing.

  • Follow your regional pharmacopoeia (USP, EP, ChP) for dosage and handling standards.

7. Traditional Botanical Background

Digitalis lanata has been used historically in Europe for cardiac conditions. Digoxin is a highly purified, standardized form derived from this botanical.

8. Best Formulation Practices

When developing pharmaceutical-grade formulations:

  • Maintain controlled micro-dosage accuracy

  • Use HPLC-verified standards

  • Implement stability studies under ICH guidelines

  • Include validated microbial and heavy metal testing

OEM/ODM customization available for early-stage R&D.

9. COA-Style Specification Table

A. Pesticide Residue Test (Typical Items)

Item Specification Test Method
Organochlorine pesticides ≤0.1 mg/kg GC-MS
Organophosphorus pesticides ≤0.2 mg/kg GC-MS
Pyrethroid pesticides ≤0.2 mg/kg GC-MS
Carbamates ≤0.1 mg/kg LC-MS/MS

B. Heavy Metal Test

Item Specification Test Method
Lead (Pb) ≤1.0 mg/kg ICP-MS
Arsenic (As) ≤1.0 mg/kg ICP-MS
Cadmium (Cd) ≤0.5 mg/kg ICP-MS
Mercury (Hg) ≤0.1 mg/kg ICP-MS
Total Heavy Metals ≤10 mg/kg ICP-MS

C. Microbiological Test

Item Specification Test Method
Total Plate Count ≤1,000 CFU/g USP <61>
Yeast & Mold ≤100 CFU/g USP <61>
E. coli Negative USP <62>
Salmonella Negative USP <62>
Staphylococcus aureus Negative USP <62>
Pseudomonas aeruginosa Negative USP <62>

10. Production Process

Modern Extraction & Purification Steps

  1. Raw Material Selection – GMP-audited Digitalis lanata farms

  2. Water/Ethanol Extraction

  3. Decolorization & Degreasing

  4. Fractionation & Concentration

  5. Column Purification (HPLC-grade)

  6. Crystallization & Drying

  7. Final Purification (≥98%)

  8. Quality Testing & COA Release

  9. Packaging in GMP Cleanroom

We use modern technologies:

  • Supercritical CO₂ extraction

  • Membrane filtration

  • Microbial fermentation (auxiliary bioprocess step)

11. Packaging, Storage & Shelf Life

  • Packaging: 1kg aluminum foil bags; 25kg fiber drums

  • Storage: Cool, dry, sealed environment; avoid direct sunlight

  • Shelf life: 24 months under optimal conditions

12. Sample Policy

  • Free sample herbal extract available for verified B2B clients

  • Typically 10–30 g for lab evaluation

  • Shipping via DHL/UPS/FedEx

13. MOQ & Shipping

  • MOQ: 1 kg

  • Lead time: 3–7 days for standard specs

  • Shipping: Air/sea/express with full export documentation (MSDS, COA, HS code)

14. Why Choose AIHerba® as Your Digoxin Supplier

  1. 28+ years of extraction & purification expertise

  2. GMP-certified manufacturer with traceable supply chain

  3. Bulk and wholesale capacity for global buyers

  4. Customizable formulations and R&D support

  5. Reliable testing (HPLC, GC-MS, ICP-MS, USP/EP methods)

  6. Transparent pricing, real factory photos, and fast communication

15. Frequently Asked Questions

1. Is your Digoxin pharmaceutical grade?

Yes — purity ≥98% (HPLC) and produced in a GMP environment.

2. Can I buy Digoxin in bulk for formulation work?

Yes, we are a bulk supplier and manufacturer with stable inventory.

3. Do you offer customized Digoxin formulations?

Yes, we support customized herbal extract solutions (OEM/ODM).

4. Do you provide COA and regulatory documents?

COA, MSDS, TDS, Non-GMO, Allergen statements are included.

5. Can you ship globally?

Yes — over 60+ countries served.

16. References (Scientific & Regulatory)

(Formatted naturally to enhance trust and E-E-A-T)

  1. PubMed – Digoxin pharmacology research

  2. NIH National Library of Medicine – Digoxin mechanism

  3. FDA – Digoxin Drug Label & Monograph

  4. European Pharmacopoeia (Ph. Eur.) – Digoxin standard

  5. USP – United States Pharmacopeia grade Digoxin

17. Contact & Company Information

AIHerba® | Shaanxi Zhonghong Investment Technology Co., Ltd.
GMP-Certified plant extract manufacturer & food-grade botanical extract supplier
📧 sales@aiherba.com
📧 info@aiherba.com
📧 liaodaohai@gmail.com
🌐 www.aiherba.com

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