Ramiprilat API Manufacturer in India

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Product Overview

Ramiprilat is the active diacid metabolite of ramipril and belongs to the angiotensin-converting enzyme (ACE) inhibitor class. Ramipril is a prodrug that is converted to ramiprilat, the pharmacologically active metabolite responsible for ACE inhibition.

Ramiprilat is a dicarboxylic acid and dipeptide-related compound with established pharmaceutical and pharmacological significance. It inhibits ACE, reducing the conversion of angiotensin I to angiotensin II and thereby contributing to vasodilation and reduced blood pressure.

The established chemical identity of Ramiprilat is CAS 87269-97-4, with molecular formula C21H28N2O5 and molecular weight 388.46 g/mol.

API / Product

Product Name: Ramiprilat
API Category: Cardiovascular API
Therapeutic Class: ACE Inhibitor
Drug Class: Angiotensin-Converting Enzyme Inhibitor
CAS Number: 87269-97-4
Molecular Formula: C21H28N2O5
Molecular Weight: 388.46 g/mol
PubChem CID: 5464096
ChEBI: CHEBI:77363
ChEMBL: CHEMBL1201365
Synonyms: Ramiprilate, Ramipril Diacid, HOE 498 Diacid, Ramiprilatum
Parent Drug: Ramipril

Ramiprilat is identified by PubChem and IUPHAR as the active metabolite of ramipril.

Chemical and Pharmaceutical Profile

Ramiprilat is the diacid form generated from ramipril following hydrolysis of the ethyl ester group. Its molecular structure contains a cyclopenta[b]pyrrole-derived ring system, peptide-like amide functionality, a phenylpropyl group and two carboxylic acid groups.

Ramiprilat has a molecular weight of 388.46 g/mol and an exact mass of 388.199822 Da. PubChem reports an XLogP3 value of 0.7, hydrogen-bond donor count of 3, hydrogen-bond acceptor count of 6, and 8 rotatable bonds.

The compound has multiple defined stereocenters consistent with its specific stereochemical pharmaceutical structure.

Pharmaceutical Applications

Ramiprilat is primarily recognized as the pharmacologically active metabolite of ramipril and is associated with ACE-inhibitor pharmacology.

Its pharmaceutical relevance includes:

  • ACE inhibitor research
  • Cardiovascular drug development
  • Hypertension-related pharmaceutical research
  • Heart failure research
  • Pharmacokinetic studies of ramipril
  • Analytical reference and impurity research
  • Development and characterization of ACE inhibitor products

Ramiprilat has also been investigated directly as an ACE inhibitor in pharmacological research.

Mechanism of Action

Ramiprilat inhibits angiotensin-converting enzyme (ACE), an enzyme involved in the conversion of angiotensin I to the potent vasoconstrictor angiotensin II.

By reducing angiotensin II formation, ACE inhibition decreases vasoconstrictor activity and reduces aldosterone-related effects. This contributes to vasodilation and reduction of blood pressure.

Ramiprilat is the active metabolite responsible for the ACE-inhibitory activity of ramipril.

Quality and Analytical Testing

Ramiprilat API quality assessment can include identity, assay, related substances, water content, residual solvents and other applicable pharmaceutical quality attributes.

Analytical control may include:

  • FTIR/IR identification
  • HPLC identification
  • HPLC assay
  • Related substances by HPLC
  • Chiral purity / stereochemical assessment where applicable
  • Water determination
  • Residual solvent testing
  • Elemental impurity assessment where applicable
  • Chromatographic system suitability

No universal USP-NF release specification for Ramiprilat was identified in the authoritative sources reviewed for this page. Therefore, numerical API release limits such as assay, individual impurities, total impurities, water and residue on ignition should be treated as product-specific/specification-dependent rather than presented as universal pharmacopoeial limits.

Manufacturing

Ramiprilat API manufacturing requires controlled chemical processing to obtain the diacid active ingredient with appropriate stereochemical purity and impurity control.

Manufacturing controls may include:

  • Qualified starting materials
  • Controlled reaction parameters
  • Ester hydrolysis
  • Process impurity monitoring
  • Purification
  • Controlled isolation
  • Drying under validated conditions
  • In-process testing
  • Final API testing
  • Batch traceability and documentation

The manufacturing process should be supported by validated analytical methods and a suitable impurity-control strategy.

Physical and Physicochemical Properties

PropertyValue
ProductRamiprilat
CAS Number87269-97-4
Molecular FormulaC21H28N2O5
Molecular Weight388.46 g/mol
PubChem CID5464096
AppearanceWhite to off-white solid
XLogP30.7
Exact Mass388.199822 Da
H-Bond Donors3
H-Bond Acceptors6
Rotatable Bonds8
StereochemistryDefined stereochemical structure
SolubilityLimited water solubility; solvent-specific
Melting Point139–141°C reported for reference material; not established as a universal pharmaceutical release criterion

The molecular and computed physicochemical data are supported by PubChem. The 139–141°C melting-point value is reported by a commercial chemical-information source and should therefore not be treated as a universal API specification.

Packaging and Storage

Ramiprilat API should be packaged in suitable pharmaceutical-grade containers that protect the material from contamination, moisture and inappropriate environmental exposure.

The final storage condition for bulk API should be established according to validated stability data and the approved product specification.

For reference-grade commercial Ramiprilat, storage at controlled low temperature has been reported by suppliers; this should not automatically be adopted as the finished API storage specification without supporting stability data.

Documentation

Typical pharmaceutical API documentation may include:

  • Certificate of Analysis (CoA)
  • Specification sheet
  • Safety Data Sheet (SDS)
  • Certificate of Origin, where applicable
  • Batch manufacturing information
  • Analytical test reports
  • Stability information, where applicable
  • Residual solvent data
  • Related-substance/impurity profile
  • Regulatory support documentation, subject to availability

Why Choose Ramiprilat API Manufacturer in India

Ramiprilat requires controlled manufacturing and analytical characterization because it is a stereochemically defined active ACE-inhibitor metabolite with multiple carboxylic acid functionalities.

A qualified Ramiprilat API Manufacturer in India should maintain appropriate controls over raw materials, synthesis, hydrolysis, purification, stereochemical quality, drying, analytical testing and batch documentation.

Product-specific specifications should be established according to the intended pharmaceutical application, validated analytical methods and applicable regulatory requirements.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) NLT 98.0% by HPLC
Loss on Drying NMT 0.5%
Residue on Ignition NMT 0.1%
Heavy Metals NMT 10 ppm
Individual Impurity NMT 0.10%
Total Impurities NMT 0.50%
Water Content NMT 1.0%
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