Description

Enalapril Ep Impurity E Maleate is a high-purity reference standard specifically used in the pharmaceutical development and quality control of the antihypertensive drug Enalapril. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification, quantification, and monitoring of process-related impurities. It is an essential material for analytical chemists, quality assurance professionals, and researchers within pharmaceutical R&D and manufacturing, particularly those focused on cardiovascular active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Enalapril and its related substances.
• Method Development & Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control & Batch Release: Used in the routine testing of Enalapril API and finished dosage forms to ensure impurity profiles meet stringent pharmacopeial specifications (USP, EP).
• Stability Studies: Employed to monitor impurity formation and degradation pathways in Enalapril products under various storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Impurity Profiling: Supports academic and industrial research into the synthesis, metabolism, and degradation chemistry of Enalapril maleate.

Basic Information

Product Name	Enalapril Ep Impurity E Maleate
CAS No.	2292151-89-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Enalapril EP Impurity E Maleate; Enalapril Related Compound E Maleate; (S)-1-[N-[(S)-1-Carboxy-3-phenylpropyl]-L-alanyl]-L-proline Maleate; Enalapril Maleate Impurity E; Enalapril Impurity E (Maleate); Enalaprilat Ester Impurity E Maleate
EINECS	Contact for details

Quality Control

Every batch of Enalapril Ep Impurity E Maleate is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including HPLC purity, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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