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IVABRADINE HYDROCHLORIDE

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Ivabradine Hydrochloride is a selective sinus node inhibitor used primarily for the management of chronic heart failure and angina pectoris. By inhibiting the If (“funny”) current in the sinoatrial node, it reduces heart rate without affecting myocardial contractility or blood pressure, improving exercise tolerance and cardiovascular outcomes.

At Bluepill Express, we manufacture and export pharmaceutical-grade Ivabradine Hydrochloride API that meets IP, BP, USP, and EP pharmacopeial standards. Produced under WHO-GMP, ISO, and cGMP-certified facilities, our API ensures high purity, crystalline consistency, and stability, suitable for tablets and fixed-dose formulations.

Each batch undergoes stringent quality testing, including HPLC, IR spectroscopy, and microbial analysis, ensuring reliable performance for global pharmaceutical manufacturers.

Pharmacological Information:

  • Therapeutic Class: Anti-anginal / Heart Rate Reducer
  • Pharmacological Category: Sinus Node Modulator
  • CAS Number: 138728-63-2
  • Molecular Formula: C27H36N2O5·HCl
  • Molecular Weight: 480.06 g/mol
  • Appearance: White to off-white crystalline powder
  • Solubility: Soluble in water and ethanol
  • Melting Point: 105°C – 107°C
  • Storage: Store in a cool, dry place below 25°C, protected from light

Mode of Action:

Ivabradine Hydrochloride selectively inhibits the If current in the sinoatrial node, reducing spontaneous pacemaker activity. This slows the heart rate, decreases myocardial oxygen demand, and improves symptoms of angina and heart failure without affecting blood pressure or cardiac contractility.

Applications and Uses:

  • Chronic Stable Angina – Reduces angina attacks and improves exercise tolerance
  • Heart Failure – Used in patients with reduced ejection fraction to control heart rate
  • Combination Therapy – Can be combined with standard heart failure treatments
  • Pharmaceutical Formulations – Tablets and fixed-dose combinations

Technical Specifications:

  • Assay (Purity): ≥ 99.0%
  • Identification: IR spectrum matches reference standard
  • Loss on Drying: ≤ 0.5%
  • Residue on Ignition: ≤ 0.1%
  • Heavy Metals: ≤ 10 ppm
  • Particle Size: Optimized for uniform tablet formulation
  • Related Substances: ≤ 0.2% (individual impurity)
  • Microbial Limits: Complies with pharmacopeial standards

Manufacturing & Quality Assurance – Bluepill Express:

  • Produced under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities
  • High-purity crystalline API suitable for oral formulations
  • COA, MSDS, and TDS provided with each batch
  • HPLC-tested for purity, stability, and impurity profiling
  • Pharmacopeial compliance: IP / BP / USP / EP

Packaging & Export Details:

  • Available Packs: 1 kg, 5 kg, 10 kg, 25 kg HDPE drums with inner liner
  • Shelf Life: 36 months from manufacturing date
  • Labeling: Export-compliant with batch number and origin
  • Export Markets: Africa, Asia, Europe, Middle East, Latin America
  • Documentation Provided:
    • Certificate of Analysis (COA)
    • Material Safety Data Sheet (MSDS)
    • Technical Data Sheet (TDS)
    • Stability Data (on request)
    • Non-GMO & Allergen-Free Declarations

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