Description

Enalapril Impurity 13 (Enalaprilat Srs Isomer) is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Enalapril and its related drug products. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The reliable identification and quantification of this isomer are essential for maintaining stringent pharmacopeial standards in cardiovascular drug manufacturing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analysis of Enalapril Maleate and Enalaprilat APIs.
• Method Development & Validation: Used in developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control (QC) Testing: Essential for routine batch release testing in pharmaceutical manufacturing to monitor and control impurity levels.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing data for impurity identification and qualification as per ICH Q3A/B guidelines.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Enalapril formulations.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the behavior of Enalapril stereoisomers.

Basic Information

Product Name	Enalapril Impurity 13 (Enalaprilat Srs Isomer)
CAS No.	192118-19-7
Molecular Formula	C18H24N2O5
Molecular Weight	348.40 g/mol
Synonyms	Enalaprilat SRS Isomer; (S,R,S)-Enalaprilat; Enalapril Impurity K; Enalapril Related Compound K; Enalaprilat Diastereomer; N-[(S)-1-Carboxy-3-phenylpropyl]-L-alanyl-L-proline; (2S)-1-[(2S)-2-[[(1S)-1-Carboxy-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic acid
EINECS	Contact for details

Quality Control

Our Enalapril Impurity 13 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity (HPLC), spectroscopic identification (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and all relevant analytical data.

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.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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