Description

Enalapril Ep Impurity A (Ssr) is a designated impurity standard used in the analytical profiling of the antihypertensive drug Enalapril. This compound is critical for pharmaceutical research and development, serving as a key reference marker for ensuring drug purity, safety, and regulatory compliance. It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the global pharmaceutical and biotechnology industries.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Enalapril Maleate active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS/MS assays.
• Quality Control and Assurance: Employed in routine batch testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Acts as a critical marker in forced degradation and long-term stability studies to understand the degradation pathways of Enalapril.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over product-related impurities.
• Research and Development: Utilized in synthetic chemistry research to study the formation and fate of process-related impurities during API manufacturing.

Basic Information

Product Name	Enalapril Ep Impurity A (Ssr)
CAS No.	1356932-13-2
Molecular Formula	C20H28N2O5
Molecular Weight	376.45 g/mol
Synonyms	Enalapril EP Impurity A; Enalapril Impurity A (EP); (2S)-1-[(2S)-2-[[(1S)-1-Carboxy-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic acid; Enalapril Diacid Impurity; Enalaprilat Impurity; Enalapril Degradation Product; SSR Impurity of Enalapril; Enalapril Related Compound A
EINECS	Contact for details

Quality Control

Our Enalapril Ep Impurity A (Ssr) is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, LC-MS, NMR, and IR to confirm identity and purity, ensuring compliance with pharmacopeial expectations. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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