Moexipril API Manufacturer in India

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Moexipril API

Moexipril is an angiotensin-converting enzyme (ACE) inhibitor and a pharmaceutical active ingredient used in antihypertensive therapy. It is a non-sulfhydryl ACE inhibitor prodrug that is converted in the body to its active metabolite, moexiprilat. Moexipril reduces the formation of angiotensin II, resulting in vasodilation and reduced blood pressure.

Moexipril has the molecular formula C₂₇H₃₄N₂O₇, molecular weight 498.6 g/mol, and CAS Number 103775-10-6.

About Moexipril API

Moexipril belongs to the ACE inhibitor class of pharmaceutical compounds. Following administration, moexipril is hydrolyzed to moexiprilat, the pharmacologically active metabolite. Moexiprilat inhibits ACE, reducing the conversion of angiotensin I to angiotensin II. This contributes to relaxation of blood vessels and reduction of blood pressure.

Moexipril has been used in the pharmaceutical treatment of hypertension and has been associated with cardiovascular therapeutic applications.

Key Features of Moexipril API

  • Active Pharmaceutical Ingredient
  • ACE inhibitor
  • Non-sulfhydryl ACE inhibitor
  • Prodrug of moexiprilat
  • CAS Number: 103775-10-6
  • Molecular Formula: C₂₇H₃₄N₂O₇
  • Molecular Weight: 498.6 g/mol
  • FDA UNII: WT87C52TJZ
  • ChEBI ID: CHEBI:6960
  • DrugBank ID: DB00691
  • Associated with antihypertensive pharmaceutical applications
  • Available in hydrochloride salt form as Moexipril Hydrochloride

Pharmaceutical Applications

Moexipril is an ACE inhibitor associated primarily with the management of hypertension. By inhibiting ACE through its active metabolite moexiprilat, it reduces angiotensin II formation and supports vasodilation.

Moexipril has also been investigated and used in cardiovascular applications where ACE inhibition is therapeutically relevant.

Mechanism of Action

Moexipril is a prodrug that is converted to moexiprilat. Moexiprilat competitively inhibits angiotensin-converting enzyme.

ACE inhibition decreases the conversion of angiotensin I to angiotensin II. Reduced angiotensin II activity decreases vasoconstriction and aldosterone-related effects, contributing to reduced vascular resistance and blood pressure.

Chemical Information

Moexipril is a stereochemically defined compound containing three defined stereocenters. PubChem reports:

  • Molecular Formula: C₂₇H₃₄N₂O₇
  • Molecular Weight: 498.6 g/mol
  • Exact Mass: 498.2366 Da
  • Topological Polar Surface Area: 114 Ų
  • XLogP3-AA: 1.2
  • Hydrogen Bond Donors: 2
  • Hydrogen Bond Acceptors: 8
  • Defined Atom Stereocenters:

Moexipril Hydrochloride

Moexipril Hydrochloride is the hydrochloride salt form of moexipril. It has the molecular formula C₂₇H₃₅ClN₂O₇, molecular weight 535.0 g/mol, and CAS Number 82586-52-5.

The hydrochloride form is particularly relevant when the API supplied or manufactured is specified as Moexipril Hydrochloride rather than the free moexipril compound.

Solubility

Moexipril is reported to be soluble in water in its hydrochloride salt form. PubChem reports approximately 10% w/v solubility in distilled water at room temperature as the HCl salt.

FDA documentation for moexipril hydrochloride reports very high water solubility, with measured solubility exceeding 150 mg/mL under certain conditions. The minimum of the solubility curve was approximately 1 mg/mL at pH 3.

The reported dissociation constants for moexipril hydrochloride are approximately pKa 3.03 and 5.40 at 25°C, demonstrating its pH-dependent ionization and solubility behavior.

Quality and Analytical Considerations

Moexipril API should be characterized using suitable validated analytical methods appropriate for pharmaceutical manufacturing.

Typical quality attributes may include:

  • Identification
  • Assay
  • Related substances
  • Water content
  • Residual solvents
  • Elemental impurities
  • Optical/stereochemical purity
  • Physical characteristics

Acceptance criteria should follow the applicable approved API specification and validated analytical procedures.

Storage and Handling

Moexipril API should be stored and handled according to the applicable approved specification, stability data and safety documentation.

Appropriate pharmaceutical handling procedures should be followed to minimize contamination and degradation during storage, transportation and manufacturing.

Packaging

Moexipril API should be packed in suitable pharmaceutical-grade containers that provide appropriate protection from contamination, moisture and environmental exposure.

Packaging configuration and available quantities should be determined according to customer requirements and applicable pharmaceutical standards.

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%
Heavy Metals NMT 20 ppm
pH (1% Solution) 4.0 – 6.0
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 1.0%
Melting Point Approximately 100°C
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