Description

Lisinopril Ep Impurity E is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Lisinopril. This compound is critical for ensuring the quality, safety, and efficacy of Lisinopril-based pharmaceutical formulations by serving as a benchmark in chromatographic purity testing. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for method development, validation, and routine batch analysis.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lisinopril API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating High-Performance Liquid Chromatography (HPLC) and related chromatographic methods in QC/QA laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, DMF) by providing impurity data required by pharmacopeial standards such as USP and EP.
• Stability Studies: Employed to monitor impurity profiles in Lisinopril products during forced degradation and long-term stability testing programs.
• Research & Development: Used in R&D for studying the degradation pathways and synthesis of Lisinopril to improve process control and purity.

Basic Information

Product Name	Lisinopril Ep Impurity E
CAS No.	85955-59-5
Molecular Formula	C21H31N3O5
Molecular Weight	405.49 g/mol
Synonyms	(2S)-1-[(2S)-6-Amino-2-[[(1S)-1-carboxy-3-phenylpropyl]amino]hexanoyl]pyrrolidine-2-carboxylic acid; Lisinopril Impurity E; (S)-Lisinopril; Lisinopril Related Compound E; N2-[(S)-1-Carboxy-3-phenylpropyl]-L-lysyl-L-proline; SQ 26,991; MK-521 Impurity E
EINECS	Contact for details

Quality Control

Every batch of Lisinopril Ep Impurity E is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature of 15-25°C. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity.

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 unknown impurity: ≤ 0.5% 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.