Milrinone API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Milrinone API

Milrinone is a bipyridine cardiotonic agent and selective phosphodiesterase-3 (PDE-3) inhibitor. It has both positive inotropic and vasodilator effects and is used primarily in hospital settings for short-term cardiovascular support.

Milrinone increases intracellular cyclic AMP in cardiac and vascular smooth muscle. In cardiac muscle, this increases contractile force, while in vascular smooth muscle it promotes relaxation and vasodilation.

Milrinone API Manufacturer in India

Milrinone is a specialized cardiovascular pharmaceutical API used in the manufacture of milrinone-containing injectable formulations.

The API is particularly relevant to pharmaceutical development involving acute heart failure, low cardiac output states and cardiovascular critical care.

Chemical Information

CAS Number: 78415-72-2
Molecular Formula: C12H9N3O
Molecular Weight: 211.22 g/mol
Chemical Name: 1,6-Dihydro-2-methyl-6-oxo-[3,4′-bipyridine]-5-carbonitrile
Drug Class: Bipyridine Phosphodiesterase Inhibitor
Therapeutic Class: Positive Inotropic Agent / Vasodilator
Therapeutic Area: Cardiology / Critical Care
Molecule Type: Synthetic Small Molecule

The USP monograph identifies Milrinone as C12H9N3O with molecular weight 211.22 and CAS 78415-72-2.

Mechanism of Action

Milrinone selectively inhibits PDE-3 in cardiac and vascular muscle.

This produces:

  • Increased intracellular cAMP
  • Increased cardiac contractility
  • Relaxation of vascular smooth muscle
  • Vasodilation
  • Increased cardiac output
  • Reduced vascular resistance

Milrinone is structurally and mechanistically distinct from cardiac glycosides and catecholamines.

Pharmaceutical Applications

Milrinone API is associated with:

  • Acute heart failure
  • Short-term cardiovascular support
  • Low cardiac output states
  • Cardiac surgery-related hemodynamic support
  • Positive inotropic therapy
  • Vasodilator therapy
  • Cardiovascular pharmaceutical research

Dosage Form Applications

Milrinone is primarily formulated as milrinone lactate injection for intravenous administration.

Commercial injectable products include a concentration equivalent to 1 mg milrinone per mL, while ready-to-use dextrose formulations may contain 200 mcg/mL.

Physical Characteristics

Milrinone is described as an off-white to tan crystalline compound. It is slightly soluble in methanol and very slightly soluble in chloroform and water according to current U.S. product labeling.

Manufacturing Process

A controlled Milrinone API manufacturing process may involve:

  1. Selection and qualification of starting materials
  2. Preparation of bipyridine intermediates
  3. Controlled chemical synthesis
  4. Introduction of the carbonitrile functionality
  5. Purification
  6. Crystallization
  7. Filtration
  8. Controlled drying
  9. Milling or sieving where applicable
  10. Final analytical testing
  11. Pharmaceutical-grade packaging

Quality Control Testing

Milrinone API quality control may include:

  • Identification by IR
  • HPLC identification
  • Assay
  • Related substances
  • Milrinone Related Compound A
  • Water content
  • Residual solvents
  • Elemental impurities
  • Residue on ignition
  • Stability testing

Storage

Store Milrinone API in a tightly closed pharmaceutical container under controlled storage conditions, protected from excessive heat, moisture and direct light.

Pharmaceutical Research

Milrinone is relevant to research involving:

  • PDE-3 inhibition
  • Cardiac contractility
  • cAMP signaling
  • Vasodilation
  • Heart failure
  • Cardiovascular pharmacology
  • Inotropic agents
  • Critical-care pharmaceuticals

Milrinone API Summary

Milrinone is a PDE-3 inhibitor and positive inotropic/vasodilator agent with CAS Number 78415-72-2, molecular formula C12H9N3O, and molecular weight 211.22 g/mol. The USP monograph defines Milrinone at NLT 98.0% and NMT 102.0%, calculated on the anhydrous basis.

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
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