Description

Quinapril Hydrochloride Ep Impurity G is a high-purity reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Quinapril Hydrochloride. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of cardiovascular medications by serving as a known impurity marker. It is essential for analytical laboratories, pharmaceutical manufacturers, and research institutions involved in method validation, stability studies, and impurity profiling to meet stringent pharmacopeial standards such as EP and USP.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Quinapril Hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation: Critical component for developing, calibrating, and validating HPLC, UPLC, and other chromatographic methods to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Used in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels and ensure product specifications are met.
• Stability Studies: Employed to track the formation of degradation products in Quinapril Hydrochloride under various stress conditions (e.g., heat, light, humidity) over time.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Research & Development (R&D): Used in synthetic chemistry R&D to understand and optimize the manufacturing process to minimize the formation of this specific impurity.

Basic Information

Product Name	Quinapril Hydrochloride Ep Impurity G
CAS No.	103775-06-0
Molecular Formula	C25H30N2O5 • HCl
Molecular Weight	474.98 g/mol
Synonyms	(3S)-2-[(2S)-2-[[(1S)-1-Carboxy-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride; Quinapril Impurity G; Quinapril Related Compound G; (S,S,S)-2-[(2-[[1-(Ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid hydrochloride; Quinapril HCl Impurity G; EP Impurity G of Quinapril Hydrochloride
EINECS	Contact for details

Quality Control

Our Quinapril Hydrochloride Ep Impurity G is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for use as a reference standard. Each batch is characterized and qualified against pharmacopeial standards (EP/BP/USP) where applicable. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identification, and impurity profile as determined by advanced techniques like HPLC and NMR. We are committed to supporting your GMP and regulatory compliance needs.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be sealed under an inert atmosphere after each use to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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