Milrinone Base API Manufacturer in India

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Milrinone Base API

Milrinone Base is a synthetic bipyridine derivative and phosphodiesterase-3 (PDE-3) inhibitor. It increases intracellular cyclic adenosine monophosphate (cAMP) by inhibiting PDE-3, producing both positive inotropic and vasodilatory effects.

Milrinone is primarily associated with short-term cardiovascular therapy, particularly in settings involving acute heart failure and low cardiac output. The pharmaceutical injectable product is commonly supplied as milrinone lactate, while Milrinone Base is the active molecular form.

Milrinone Base API Manufacturer in India

Milrinone Base is a specialized cardiovascular pharmaceutical API used in pharmaceutical development and manufacture. Important quality attributes include identity, assay, related substances, residual solvents, water content and other applicable pharmaceutical parameters.

Chemical Information

CAS Number: 78415-72-2
Molecular Formula: C12H9N3O
Molecular Weight: 211.22 g/mol
IUPAC Name: 6-Methyl-2-oxo-5-(pyridin-4-yl)-1,2-dihydropyridine-3-carbonitrile
Synonyms: Milrinone, Milrinone Base
Drug Class: Phosphodiesterase-3 Inhibitor
Therapeutic Class: Cardiovascular Agent / Inodilator
Therapeutic Area: Cardiology / Critical Care

PubChem confirms the formula C12H9N3O, molecular weight 211.22 g/mol, and CAS 78415-72-2.

Mechanism of Action

Milrinone selectively inhibits phosphodiesterase type 3 (PDE-3). PDE-3 inhibition increases intracellular cAMP in cardiac and vascular smooth-muscle cells.

The resulting pharmacological effects include:

  • Increased myocardial contractility
  • Increased cardiac output
  • Peripheral vasodilation
  • Reduced vascular resistance
  • Reduced pulmonary vascular resistance

Pharmaceutical Applications

Milrinone is associated with:

  • Acute heart failure
  • Low cardiac output states
  • Cardiovascular critical-care applications
  • Short-term inotropic support
  • Vasodilator therapy
  • PDE-3 inhibitor research

Dosage Form Applications

Milrinone is primarily used in intravenous pharmaceutical formulations. Commercial injectable formulations commonly contain milrinone lactate, rather than the unmodified free base.

Physical and Chemical Characteristics

Milrinone Base is a crystalline pharmaceutical compound. PubChem reports a calculated molecular weight of 211.22 g/mol and an exact mass of 211.0746 Da.

A reported melting point for milrinone is approximately 315°C.

Manufacturing Process

A controlled Milrinone Base API manufacturing process may involve:

  1. Selection and qualification of starting materials
  2. Preparation of pyridone intermediates
  3. Controlled chemical synthesis
  4. Introduction of the nitrile functionality
  5. Pyridyl-group incorporation
  6. Purification
  7. Crystallization
  8. Filtration
  9. Controlled drying
  10. Final analytical testing
  11. Pharmaceutical-grade packaging

Quality Control Testing

Typical Milrinone Base API testing may include:

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

Storage

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

Pharmaceutical Research

Milrinone is relevant to research involving:

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

Milrinone Base API Summary

Milrinone Base is a PDE-3 inhibitor and cardiovascular inodilator with CAS Number 78415-72-2, molecular formula C12H9N3O, and molecular weight 211.22 g/mol. It increases intracellular cAMP and produces positive inotropic and vasodilatory effects.

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 2.0%
Residue on Ignition NMT 0.5%
Water Content NMT 1.0%
Melting Point Approximately 315°C
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