Description

Quinapril Hydrochloride Ep Impurity I is a critical reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Quinapril Hydrochloride. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark for impurity profiling and analytical method validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and testing of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Quinapril Hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation: A key component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopoeial specifications (e.g., EP, USP).
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability testing of drug products.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports process chemistry research to understand and minimize impurity formation during API synthesis.

Basic Information

Product Name	Quinapril Hydrochloride Ep Impurity I
CAS No.	89300-89-0
Molecular Formula	C25H30N2O5 • HCl
Molecular Weight	474.98 g/mol
Synonyms	(3S)-2-[(2S)-2-[[(1S)-1-Carboxy-3-phenylpropyl]amino]propanoyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, ethyl ester, hydrochloride; Quinapril Impurity I (EP); Quinapril Related Compound I; (S,S,S)-2-[2-[(1-Carboxy-3-phenylpropyl)amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid ethyl ester hydrochloride; Accupril Impurity I
EINECS	Contact for details

Quality Control

Our Quinapril Hydrochloride Ep Impurity I is manufactured under strict quality systems to ensure it meets the stringent requirements for a pharmaceutical reference standard. Each batch is subjected to comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity determination by HPLC, and confirmation of structure. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results and confirming compliance with relevant pharmacopoeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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