Hydralazine Hydrochloride API | Antihypertensive Pharmaceutical API Manufacturer in India

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

Hydralazine Hydrochloride API

Hydralazine Hydrochloride is the hydrochloride salt of hydralazine, a direct-acting vasodilator used primarily in the management of hypertension. It acts predominantly on arteriolar smooth muscle, producing relaxation of peripheral resistance vessels and reducing systemic vascular resistance.

Hydralazine Hydrochloride is an established pharmaceutical active ingredient used in oral and injectable formulations, depending on the product and clinical application.

Hydralazine Hydrochloride API Manufacturer in India

Hydralazine Hydrochloride is a synthetic cardiovascular pharmaceutical API requiring controlled chemical synthesis, purification and analytical characterization. Quality control focuses on identity, assay, related substances, water content, residual solvents and control of elemental impurities.

Chemical Information

CAS Number: 304-20-1
Molecular Formula: C8H9ClN4
Molecular Weight: 196.64 g/mol
Chemical Name: Hydralazine Hydrochloride
Drug Class: Vasodilator
Pharmacological Class: Direct-Acting Arteriolar Vasodilator
Therapeutic Class: Antihypertensive
Therapeutic Area: Cardiovascular

Mechanism of Action

Hydralazine produces direct relaxation of arteriolar vascular smooth muscle, leading to decreased peripheral vascular resistance.

The reduction in arterial resistance lowers blood pressure. Hydralazine can also trigger compensatory sympathetic responses, including increased heart rate and cardiac output, which is one reason it may be used in combination with other cardiovascular medicines.

Pharmaceutical Applications

Hydralazine Hydrochloride is used in the treatment of:

  • Hypertension
  • Severe hypertension requiring rapid blood-pressure reduction
  • Hypertension associated with pregnancy in appropriate clinical settings
  • Certain heart-failure treatment regimens in combination with other agents

The exact indication depends on the dosage form and applicable regulatory labeling.

Hydralazine Hydrochloride in Hypertension

Hydralazine primarily lowers systemic vascular resistance through arteriolar dilation. Because it has comparatively less direct effect on venous capacitance vessels, its principal hemodynamic action is reduction of arterial resistance.

Physical and Chemical Properties

Hydralazine Hydrochloride is a synthetic nitrogen-containing heterocyclic compound supplied as a hydrochloride salt. It is generally obtained as a white to off-white crystalline powder and is soluble in water.

The hydrochloride salt provides a stable pharmaceutical form suitable for incorporation into dosage forms.

Quality and Analytical Testing

Hydralazine Hydrochloride API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • Assay by HPLC
  • Related substances
  • Water content
  • Residual solvents
  • Residue on ignition
  • Chloride identification
  • Elemental impurities
  • pH
  • Melting/decomposition range

Storage

Hydralazine Hydrochloride should be stored in a tightly closed container, protected from excessive heat, moisture and direct light. Exact storage requirements should follow validated stability data and the applicable product-specific specification.

Pharmaceutical Research and Development

Hydralazine Hydrochloride remains relevant to pharmaceutical research involving arteriolar vasodilation, vascular smooth-muscle relaxation, blood-pressure regulation and cardiovascular pharmacology.

Hydralazine Hydrochloride API Summary

Hydralazine Hydrochloride is a direct-acting arteriolar vasodilator with CAS Number 304-20-1, molecular formula C8H9ClN4, and molecular weight 196.64 g/mol. It lowers blood pressure primarily by reducing peripheral arteriolar resistance and is used in selected antihypertensive treatment settings.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Loss on Drying NMT 2.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
pH (1% Solution) 3.5 – 5.5
Total Impurities NMT 2.0%
Water Content NMT 2.0%
Get Bulk Quote via WhatsApp