Fenoldopam API Manufacturer & Supplier in India

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

Fenoldopam API Manufacturer and Supplier in India

Fenoldopam is a synthetic pharmaceutical active ingredient and a selective dopamine D1 receptor agonist. It belongs to the benzazepine class of compounds and is primarily associated with cardiovascular and critical-care pharmaceutical applications. Fenoldopam is identified by CAS Number 67227-56-9, with molecular formula C₁₆H₁₆ClNO₃ and molecular weight 305.75 g/mol.

About Fenoldopam

Fenoldopam acts selectively on dopamine D1 receptors and produces vasodilatory effects, particularly in the arterial circulation. Through activation of dopamine D1 receptors, Fenoldopam can reduce vascular resistance and promote an antihypertensive effect.

Fenoldopam is supplied as an active pharmaceutical ingredient for pharmaceutical research, development and manufacturing applications.

Chemical Information

Fenoldopam is chemically characterized as a benzazepine derivative containing hydroxyl groups and a chlorine substituent. Its CAS Registry Number is 67227-56-9, molecular formula is C₁₆H₁₆ClNO₃, and molecular weight is 305.75 g/mol.

Mechanism of Action

Fenoldopam is a selective dopamine D1 receptor agonist. Activation of D1 receptors contributes to relaxation of vascular smooth muscle and arterial vasodilation. This pharmacological activity is associated with decreased vascular resistance and reduction in blood pressure.

Pharmaceutical Applications

Fenoldopam is associated with the treatment of severe hypertension in controlled clinical settings. Its rapid vasodilatory activity makes it relevant to hospital and critical-care applications where rapid control of blood pressure may be required.

The specific therapeutic indication, dosage form and regulatory status may vary according to the applicable country and approved pharmaceutical labeling.

Fenoldopam API Quality

Pharmaceutical-grade Fenoldopam API should undergo appropriate quality testing to ensure identity, purity and consistency. Typical quality parameters may include identification, assay, related substances, residual solvents, water content, elemental impurities and other applicable physicochemical characteristics.

The exact acceptance limits should be based on the approved manufacturer specification and current Certificate of Analysis (CoA) for the supplied API.

Technical Documentation

Depending on customer and regulatory requirements, documentation for Fenoldopam API may include:

  • Certificate of Analysis (CoA)
  • Product specification
  • Safety Data Sheet (SDS/MSDS)
  • Batch-related documentation
  • Residual solvent information
  • Related-substance profile
  • Stability information
  • Regulatory documentation

Storage

Fenoldopam API should be stored in a tightly closed container under the manufacturer's recommended storage conditions and protected from excessive moisture, heat and direct light. The manufacturer's validated storage conditions should be followed for commercial material.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
pH (1% Solution) 5.5 – 6.5
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
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