Description

Lisinopril Ep Impurity G CAS NO 1356839-89-8 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Lisinopril, an angiotensin-converting enzyme (ACE) inhibitor. It is an essential tool for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and contract research organizations (CROs) involved in method validation, stability studies, and impurity profiling to meet stringent pharmacopeial standards like USP and EP.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Impurity G in Lisinopril drug substances and finished products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection and separation.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor and control impurity levels, ensuring every batch of Lisinopril API meets specified purity criteria.
• Stability Studies & Forced Degradation: Employed to identify and track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions & Compliance: Essential for preparing documentation for regulatory agencies (FDA, EMA, etc.), demonstrating thorough impurity characterization and control strategies.
• Research on Degradation Pathways: Used by research scientists to study the chemical degradation mechanisms of Lisinopril, aiding in the formulation of more stable drug products.

Basic Information

Product Name	Lisinopril Ep Impurity G
CAS No.	1356839-89-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lisinopril Impurity G; Lisinopril Related Compound G; (2S)-1-[(2S)-6-Amino-2-[[(1S)-1-carboxy-3-phenylpropyl]amino]hexanoyl]pyrrolidine-2-carboxylic acid; Lisinopril EP Impurity G; Lisinopril USP Impurity G; Lisinopril Degradation Product; ACE Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Lisinopril Ep Impurity G is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and conformity to high-grade reference standard specifications. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results for assay, related substances, and other critical parameters. We support compliance with USP, EP, and ICH guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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