Trandolapril API Manufacturer and Supplier in India

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

Trandolapril API Manufacturer and Supplier in India

Swapnroop Drugs & Pharmaceuticals is a manufacturer and supplier of Trandolapril API for pharmaceutical applications and regulated drug-product manufacturing. Trandolapril is an angiotensin-converting enzyme (ACE) inhibitor and a prodrug that is converted in the body to its active metabolite, trandolaprilat.

Trandolapril is chemically identified by CAS No. 87679-37-6, with molecular formula C24H34N2O5 and molecular weight approximately 430.54 g/mol. It is a stereochemically defined synthetic small-molecule API belonging to the ACE inhibitor class.

Trandolapril API Overview

Trandolapril is used as an active pharmaceutical ingredient in formulations intended for the management of hypertension and other cardiovascular indications where ACE inhibition is therapeutically appropriate. Following administration, trandolapril is metabolized to trandolaprilat, which provides the principal ACE-inhibitory activity.

As a pharmaceutical API, Trandolapril requires controlled identity, assay, related substances, water content, residue on ignition and stereochemical characteristics. Its current USP specifications include an assay range of 98.0%–102.0% on an anhydrous basis, together with defined limits for specified and unspecified related substances.

Chemical and Pharmaceutical Profile

  • Product Name: Trandolapril
  • CAS Number: 87679-37-6
  • Molecular Formula: C24H34N2O5
  • Molecular Weight: 430.54 g/mol
  • UNII: 1T0N3G9CRC
  • Therapeutic Class: ACE Inhibitor
  • API Category: Cardiovascular / Antihypertensive API
  • Physical Form: Crystalline solid
  • Active Metabolite: Trandolaprilat
  • Appearance: Colorless to white crystalline solid
  • Storage: Tight, light-resistant packaging under appropriate controlled storage conditions

The molecular formula, CAS number and molecular weight are consistent with recognized chemical and pharmaceutical databases.

Pharmaceutical Applications

Trandolapril API is primarily associated with pharmaceutical formulations for:

  • Hypertension management
  • ACE inhibitor therapy
  • Cardiovascular treatment applications
  • Formulations requiring a trandolapril active pharmaceutical ingredient
  • Development and manufacture of finished pharmaceutical dosage forms

Trandolapril API Manufacturer and Supplier

Swapnroop Drugs & Pharmaceuticals provides Trandolapril API manufacturing and supply support in India, with emphasis on controlled pharmaceutical-grade material, consistent quality and documentation appropriate for pharmaceutical customers.

The API can be supplied for formulation development, commercial pharmaceutical manufacturing and regulated-market requirements subject to applicable customer specifications and regulatory requirements.

Packaging and Storage

Trandolapril should be packaged in suitable, well-closed/tight pharmaceutical containers that provide protection from environmental exposure. Light protection should be maintained where required by the applicable specification.

Storage conditions should follow the approved product/API specification and applicable GMP requirements.

Documentation

Typical pharmaceutical documentation may include:

  • Certificate of Analysis (CoA)
  • Batch-specific analytical results
  • Product specification
  • Safety Data Sheet (SDS)
  • Manufacturing and quality documentation
  • Regulatory documentation, where applicable
  • Stability-related documentation, where applicable

Why Choose Swapnroop for Trandolapril API?

Swapnroop Drugs & Pharmaceuticals focuses on supplying pharmaceutical APIs with controlled specifications, consistent batch quality and professional technical support. For Trandolapril, the company supports pharmaceutical manufacturers and customers seeking a reliable Trandolapril API manufacturer and supplier in India.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0%–102.0%
Residue on Ignition NMT 0.1%
pH (1% Solution) 4.9–6.3
Individual Impurity NMT 0.1%
Total Impurities NMT 0.5%
Water Content NMT 0.2%
Specific Rotation −16.5° to −18.5° at 20°C
Melting Point Approximately 119–125°C
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