Description

Enalaprilat EP Impurity G 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 and efficacy of the active pharmaceutical ingredient (API) enalaprilat by serving as a known impurity marker. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in method validation, stability studies, and regulatory compliance testing for cardiovascular drugs.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of Enalaprilat EP Impurity G in bulk drug substances and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Release Testing: Employed in routine QC laboratories to ensure that enalaprilat API and related drug products meet stringent pharmacopeial specifications (EP, USP).
• Stability Studies: Acts as a benchmark to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light) during drug shelf-life studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Utilized in synthetic chemistry R&D to understand and optimize the manufacturing process to minimize the formation of this impurity.

Basic Information

Product Name	Enalaprilat EP Impurity G
CAS No.	284677-66-3
Molecular Formula	C18H24N2O5
Molecular Weight	348.40 g/mol
Synonyms	(2S)-1-[(2S)-2-[[(1S)-1-Carboxy-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic acid; Enalaprilat Impurity G; Enalaprilat Related Compound G; Enalaprilat Diacid Impurity; (S,S,S)-Enalaprilat; N2-[(S)-1-Carboxy-3-phenylpropyl]-L-alanyl-L-proline; L-Proline, N2-[(S)-1-carboxy-3-phenylpropyl]-L-alanyl-
EINECS	Contact for details

Quality Control

Our Enalaprilat EP Impurity G is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data and traceable results are provided for every lot, supporting compliance with cGMP, ICH, and relevant pharmacopeial (EP/USP) guidelines.

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 under inert conditions or in a desiccator after opening to prevent degradation. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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