Indoramin API Manufacturer in India

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Indoramin API Manufacturer in India

Indoramin is a synthetic alpha-1 adrenergic receptor antagonist and active pharmaceutical ingredient used primarily as an antihypertensive agent. It produces vasodilation by blocking peripheral alpha-1 adrenergic receptors, thereby reducing vascular resistance and blood pressure.

Indoramin has the molecular formula C22H29N3O2 and a molecular weight of approximately 367.49 g/mol. Its CAS Number is 2681-72-9.

Indoramin API Overview

Indoramin is an orally active quinazoline-related alpha-adrenergic antagonist. It reduces the effects of norepinephrine at peripheral alpha-1 adrenergic receptors, resulting in relaxation of vascular smooth muscle.

The API has been used in pharmaceutical formulations for the management of hypertension and has also been investigated or used in connection with urinary tract symptoms associated with benign prostatic conditions.

Mechanism of Action

Indoramin selectively blocks alpha-1 adrenergic receptors in vascular smooth muscle. This reduces sympathetic vasoconstriction and causes relaxation of peripheral blood vessels.

The resulting decrease in peripheral vascular resistance contributes to a reduction in blood pressure.

Pharmaceutical Applications

Indoramin API is used in the development and manufacture of:

  • Antihypertensive formulations
  • Alpha-1 adrenergic antagonist products
  • Cardiovascular pharmaceutical products
  • Oral pharmaceutical formulations
  • Vascular smooth-muscle relaxant products
  • Pharmaceutical research and development

Indoramin API Manufacturing

Indoramin is a chemically synthesized small-molecule API. Manufacturing involves controlled chemical synthesis followed by purification, crystallization and drying.

Quality control may include identification, assay, related substances, residual solvents, water content, residue on ignition and elemental impurity testing according to the applicable approved specification.

Physical and Chemical Properties

Indoramin is generally supplied as a white to off-white crystalline powder. It has limited solubility in water and is handled as a pharmaceutical-grade solid API.

Storage

Indoramin should be stored in a tightly closed container, protected from excessive moisture, heat and direct light. Storage conditions should follow the manufacturer's current CoA, SDS and validated stability requirements.

Quality Documentation

Depending on the intended pharmaceutical application, documentation may include:

  • Certificate of Analysis (CoA)
  • Safety Data Sheet (SDS)
  • Product specification
  • HPLC purity report
  • Residual-solvent information
  • Water-content information
  • Stability information
  • Regulatory documentation

Conclusion

Indoramin is an alpha-1 adrenergic receptor antagonist with vasodilatory activity. Its ability to reduce peripheral vascular resistance makes it a pharmaceutical ingredient associated primarily with antihypertensive applications.

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%
Total Impurities NMT 2.0%
Water Content NMT 1.0%
Melting Point Approximately 128–132°C
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