Midodrine HCl API Manufacturer in India

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Midodrine HCl API

Midodrine Hydrochloride is the hydrochloride salt of midodrine, an orally active alpha-1 adrenergic receptor agonist used as an active pharmaceutical ingredient in pharmaceutical formulations. It is primarily associated with the management of symptomatic orthostatic hypotension.

Midodrine HCl is a prodrug that is converted in the body to desglymidodrine, an active metabolite that produces vasoconstriction through stimulation of peripheral alpha-1 adrenergic receptors.

Midodrine HCl API Manufacturer in India

Midodrine Hydrochloride is a well-characterized cardiovascular pharmaceutical API used in the development and manufacture of oral formulations. Important quality attributes include identity, assay, related substances, water content, residual solvents and other parameters defined in the applicable API specification.

Chemical Information

CAS Number: 3092-17-9

Molecular Formula: C12H20ClN3O2

Molecular Weight: 257.76 g/mol

Chemical Name: (RS)-2-Amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]acetamide hydrochloride

Drug Class: Alpha-Adrenergic Agonist

Therapeutic Class: Vasopressor / Antihypotensive Agent

Therapeutic Area: Cardiovascular

Molecule Type: Synthetic Small Molecule

Mechanism of Action

Midodrine HCl is converted to its active metabolite, desglymidodrine, which selectively stimulates peripheral alpha-1 adrenergic receptors.

This activity results in:

  • Peripheral vasoconstriction
  • Increased vascular tone
  • Increased venous return
  • Increased blood pressure
  • Reduction of symptoms associated with orthostatic hypotension

The active metabolite has limited penetration into the central nervous system, and its principal pharmacological effects occur through peripheral alpha-1 receptor activation.

Pharmaceutical Applications

Midodrine HCl API is used in pharmaceutical development related to:

  • Symptomatic orthostatic hypotension
  • Antihypotensive formulation development
  • Cardiovascular pharmaceutical research
  • Alpha-1 adrenergic receptor research
  • Vasopressor drug development
  • Pharmaceutical API manufacturing
  • Analytical and quality-control testing

Cardiovascular Applications

Midodrine Hydrochloride is particularly relevant to formulations designed to increase blood pressure in patients experiencing symptomatic orthostatic hypotension.

Its active metabolite increases peripheral vascular resistance through alpha-1 adrenergic receptor stimulation, supporting its use in pharmaceutical development for blood-pressure management.

Physical Characteristics

Midodrine Hydrochloride is generally described as a white to off-white crystalline powder or solid. It is characterized by its salt form, chemical purity and other physicochemical properties according to the applicable API specification.

Quality Control Testing

Typical quality-control testing for Midodrine HCl API may include:

  • Identification by IR
  • HPLC identification
  • Assay by HPLC
  • Related substances
  • Individual impurities
  • Total impurities
  • Water content
  • Residual solvents
  • Elemental impurities
  • Optical rotation, where applicable
  • Particle-size distribution, where applicable
  • Stability testing

Storage

Midodrine HCl should be stored in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light. Final storage requirements should follow validated stability data and the approved API specification.

Pharmaceutical Research

Midodrine HCl is relevant to research involving:

  • Alpha-1 adrenergic receptors
  • Peripheral vasoconstriction
  • Orthostatic hypotension
  • Cardiovascular pharmacology
  • Blood-pressure regulation
  • Vasopressor drug development
  • Pharmaceutical formulation development
  • Analytical pharmaceutical research

Midodrine HCl API Manufacturer

Midodrine HCl is a specialized pharmaceutical API suitable for qualified formulation development, pharmaceutical manufacturing and research applications. The material can be evaluated according to applicable customer specifications, validated analytical methods and relevant pharmaceutical quality requirements.

For Midodrine HCl API availability, technical documentation, specifications and commercial requirements, contact the API manufacturer.

Why Choose Midodrine HCl API?

  • Well-characterized alpha-1 adrenergic agonist API
  • Established pharmaceutical application
  • Defined hydrochloride salt form
  • Suitable for oral formulation development
  • Useful for cardiovascular pharmaceutical research
  • Well-defined chemical identity
  • Suitable for qualified pharmaceutical manufacturing requirements
  • Technical and quality documentation support

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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