Quinaprilat API Manufacturer in India

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

Product Overview

Quinaprilat is the active dicarboxylic acid metabolite of quinapril and belongs to the angiotensin-converting enzyme (ACE) inhibitor class. Quinapril is converted by deesterification to quinaprilat, which is responsible for the principal ACE-inhibitory pharmacological activity.

Quinaprilat is a synthetic dicarboxylic acid and peptidyl-dipeptidase A inhibitor. It inhibits ACE, reducing the conversion of angiotensin I to the vasoconstrictor angiotensin II.

Chemical Characteristics

  • Product Name: Quinaprilat
  • Synonyms: Quinapril diacid, Quinaprilate, CI-928
  • CAS Number: 82768-85-2
  • Molecular Formula: C₂₃H₂₆N₂O₅
  • Molecular Weight: 410.50 g/mol
  • PubChem CID: 107994
  • UNII: 34SSX5LDE5
  • ChEBI ID: CHEBI:140296
  • ChEMBL ID: CHEMBL1733
  • IUPAC Name: (3S)-2-[(2S)-2-[[(1S)-1-carboxy-3-phenylpropyl]amino]propanoyl]-3,4-dihydro-1H-isoquinoline-3-carboxylic acid
  • InChIKey: FLSLEGPOVLMJMN-YSSFQJQWSA-N
  • Exact Mass: 410.18417193 Da
  • XLogP3-AA: 0.5
  • Hydrogen Bond Donors: 3
  • Hydrogen Bond Acceptors: 6
  • Topological Polar Surface Area: 107 Ų

These chemical identity and physicochemical values are reported by PubChem.

Pharmacological Class

Quinaprilat is classified as an ACE inhibitor and antihypertensive agent. It acts by inhibiting angiotensin-converting enzyme, also known as peptidyl-dipeptidase A.

Mechanism of Action

Quinaprilat inhibits angiotensin-converting enzyme (ACE), preventing the conversion of angiotensin I into angiotensin II.

Reduced angiotensin II formation decreases vasoconstriction and reduces aldosterone-mediated sodium and fluid retention. ACE also functions as kininase II, an enzyme involved in bradykinin degradation; therefore, ACE inhibition can additionally influence bradykinin levels.

Quinapril itself is a prodrug and is deesterified after absorption to form quinaprilat. Current U.S. labeling identifies quinaprilat as the principal active metabolite of quinapril.

Pharmaceutical Applications

Quinaprilat is principally relevant as:

  • An active ACE-inhibitory compound
  • A pharmaceutical reference standard
  • An analytical reference material
  • A research compound for ACE-inhibitor development
  • A metabolite standard for quinapril pharmacokinetic analysis
  • An API/intermediate for specialized pharmaceutical development where applicable

Quinapril-containing pharmaceutical products are used for hypertension and congestive heart failure, with quinaprilat providing the principal ACE-inhibitory activity.

Physical and Physicochemical Properties

Quinaprilat is a dicarboxylic acid with molecular weight 410.50 g/mol. PubChem reports a calculated XLogP3-AA of 0.5 and a topological polar surface area of 107 Ų.

A hydrate form is also separately identified as Quinaprilat hydrate, CAS 1435786-09-6, with molecular formula C₂₃H₂₈N₂O₆ and molecular weight 428.5 g/mol. The anhydrous/free-acid form and hydrate should therefore not be treated as interchangeable for CMS chemical specifications.

Analytical Profile

Quinaprilat API/reference material can be characterized using:

  • HPLC/UPLC
  • LC-MS
  • UV spectroscopy
  • IR spectroscopy
  • NMR spectroscopy
  • Related-substance analysis
  • Residual-solvent analysis
  • Water-content determination
  • Chiral/stereochemical analysis where applicable

Chromatographic analysis is particularly important for distinguishing Quinaprilat from quinapril and controlling process-related or degradation impurities.

API Quality and Impurity Control

Quality control should address:

  • Identity
  • Assay
  • Related substances
  • Degradation products
  • Residual solvents
  • Water content
  • Elemental impurities
  • Stereochemical integrity
  • Appearance
  • Salt/hydrate state, where applicable

Because Quinaprilat is structurally and stereochemically defined, analytical control should ensure that the intended chemical form is maintained throughout manufacturing and storage.

Important: I could not verify a current publicly accessible USP/Ph. Eur. API monograph providing universal numerical assay and impurity limits specifically for Quinaprilat. Therefore, unsupported limits should not be presented as universal release specifications.

Stereochemical Characteristics

Quinaprilat has three defined stereocenters, corresponding to the stereochemical configuration represented in its PubChem structure and IUPAC name as (3S,2S,1S). Its InChI explicitly specifies three stereochemical centers.

Stereochemical purity can therefore be an important quality attribute for Quinaprilat, particularly where the API is manufactured as a defined stereochemical form.

Storage and Handling

Storage conditions should be established using validated stability data for the specific Quinaprilat form, including whether the material is anhydrous or hydrated.

Recommended handling practices include:

  • Store in a tightly closed container.
  • Protect from excessive moisture.
  • Protect from direct light where required.
  • Avoid unnecessary heat exposure.
  • Minimize prolonged exposure to atmospheric conditions.
  • Follow the applicable SDS and validated stability requirements.

Documentation

Typical pharmaceutical API documentation may include:

  • Certificate of Analysis (CoA)
  • Safety Data Sheet (SDS)
  • HPLC assay chromatogram
  • Related-substance chromatogram
  • LC-MS data
  • IR spectrum
  • NMR spectrum
  • Water-content data
  • Residual-solvent report
  • Elemental impurity data
  • Stereochemical/chiral purity data
  • Stability information
  • Batch analytical report

Pharmaceutical API Manufacturing

Quinaprilat manufacturing requires controlled chemical synthesis, purification, isolation and analytical characterization. Particular attention should be given to stereochemical integrity, carboxylic-acid form, impurity control and hydrate/solvate state.

Where Quinaprilat is intended as a pharmaceutical API or reference material, the final material should comply with the applicable registered or customer-approved specification.

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 0.5%
Residue on Ignition NMT 0.2%
Individual Impurity NMT 0.10%
Total Impurities NMT 0.50%
Water Content NMT 0.5%
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