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Digoxin Micronised API is a potent cardiac glycoside derived from the leaves of Digitalis lanata (foxglove plant). It is widely used in the management of congestive heart failure (CHF) and certain types of cardiac arrhythmias, especially atrial fibrillation. The micronised form ensures enhanced solubility, better absorption, and improved bioavailability, resulting in consistent therapeutic efficacy at lower doses.
At Bluepill Express, we manufacture Digoxin Micronised API under WHO-GMP, ISO 9001:2015, and cGMP standards, ensuring global-quality compliance and pharmaceutical-grade purity. The product meets all USP / BP / IP pharmacopoeial standards and is available with comprehensive documentation including DMF, COA, and MSDS.
Bluepill Express specializes in large-scale, high-quality API manufacturing and export, providing Digoxin Micronised in bulk for global pharmaceutical companies, contract formulators, and licensed manufacturers.
Therapeutic Applications:
- Management of congestive heart failure (CHF)
- Control of atrial fibrillation and atrial flutter
- Treatment of supraventricular tachycardia (SVT)
- Improves cardiac contractility and output
- Reduces ventricular rate in atrial arrhythmia
Mechanism of Action:
Digoxin Micronised works by inhibiting the Na⁺/K⁺-ATPase pump in myocardial cells, leading to an increase in intracellular calcium levels. This enhances myocardial contractility (positive inotropic effect) and prolongs the refractory period of the atrioventricular node, stabilizing irregular heart rhythms.
It also provides neurohormonal modulation, reducing sympathetic activity and improving cardiac efficiency.
Technical Specifications:
- Chemical Name: Digoxin (Micronised)
- Molecular Formula: C₄₁H₆₄O₁₄
- Molecular Weight: 780.95 g/mol
- CAS Number: 20830-75-5
- Description: White to off-white crystalline powder
- Solubility: Slightly soluble in water, soluble in alcohol and chloroform
- Assay (on dried basis): NLT 98.0%
- Particle Size (Micronised): D90 ≤ 10 microns
- Melting Point: 230°C (decomposes)
- Storage: Store below 30°C in a tightly sealed container, protected from light and moisture
Pharmacological Classification:
- Therapeutic Class: Cardiac Glycoside / Cardiotonic
- Pharmacopoeial Standards: USP / BP / IP
- Dosage Form Applications:
- Tablets (0.125 mg, 0.25 mg)
- Injections
- Oral solutions
Quality & Manufacturing by Bluepill Express:
- Manufactured in WHO-GMP, ISO-certified, and cGMP-compliant facilities
- Complies with USP / BP / IP standards
- Stringent HPLC and UV spectrophotometric analysis for assay and purity
- Supplied with full regulatory documentation: DMF, COA, MSDS, and Stability Data
- Micronised particle technology for consistent dissolution and bioavailability
- Long shelf life with controlled moisture and impurity profile
Advantages of Bluepill Express Digoxin Micronised API
- High assay value and low impurity profile
- Enhanced bioavailability due to micronised particle size
- Meets global regulatory compliance for export to Asia, Africa, Europe, and Latin America
- Consistent batch-to-batch uniformity
- Technical and regulatory support for formulation partners
Pharmacokinetic Benefits of Micronised Form:
- Faster absorption due to increased surface area
- Reduced dosage variability between patients
- Stable plasma concentration levels
- Optimized for low-dose formulations ensuring safety and efficacy
Packaging & Export Information:
- Packaging: 1 kg / 5 kg / 25 kg HDPE containers with double-layered LDPE inner bag
- Labeling: Complies with international labeling norms
- Export Markets: Africa, Asia-Pacific, Middle East, Europe, Latin America
- Documents Provided: COA, MSDS, DMF (on request), Non-GMO & BSE/TSE Free Declaration
