Description

Indolapril Hydrochloride [Usan] is a high-purity active pharmaceutical ingredient (API) belonging to the angiotensin-converting enzyme (ACE) inhibitor class. This compound is critical for the formulation of cardiovascular medications, offering reliable therapeutic efficacy for managing hypertension and heart failure. It is primarily required by pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in the production of generic and branded prescription drugs.

Application

• Pharmaceutical API: Primary active ingredient in antihypertensive and heart failure medications.
• Generic Drug Formulation: Core component for the development and production of generic versions of ACE inhibitor drugs.
• Clinical Research: Used in preclinical and clinical studies for cardiovascular disease research.
• Reference Standard: Serves as a high-purity analytical standard for quality control and regulatory testing in laboratories.
• Finished Dosage Manufacturing: Incorporated into final solid oral dosage forms such as tablets and capsules.

Basic Information

Product Name	Indolapril Hydrochloride [Usan]
CAS No.	80828-32-6
Molecular Formula	C22H27N2O5•HCl
Molecular Weight	444.92 g/mol
Synonyms	Indolapril HCl; Indolapril Hydrochloride; (S)-1-[N2-(1-Carboxy-3-phenylpropyl)-L-lysyl]-L-proline, 2-ethyl ester, monohydrochloride; SQ 26,991; Indolaprilum; UNII-6HZ5X1N41B
EINECS	Contact for details

Quality Control

Our Indolapril Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.