Description

Enalaprilat EP Impurity F is a high-purity reference standard critical for pharmaceutical quality control and regulatory compliance. This compound is specifically used in the analytical profiling of Enalapril and Enalaprilat, ensuring the safety and efficacy of these important cardiovascular drugs. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in method development, validation, and impurity monitoring.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of Enalapril Maleate and Enalaprilat APIs.
• Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to quantify impurities in drug substances and products.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor impurity levels against ICH, USP, and EP specification limits.
• Stability Studies: Employed to identify and track the formation of this specific degradation product during forced degradation and long-term stability studies.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control.
• Research & Development: Supports R&D efforts in understanding the degradation pathways and chemistry of angiotensin-converting enzyme (ACE) inhibitors.

Basic Information

Product Name	Enalaprilat EP Impurity F
CAS No.	90988-18-4
Molecular Formula	C18H24N2O5
Molecular Weight	348.40 g/mol
Synonyms	(S)-1-[(S)-1-Carboxy-3-phenylpropyl]-L-prolyl-L-alanine; L-Alanine, N-[(1S)-1-carboxy-3-phenylpropyl]-L-prolyl-, (S)-; Enalapril Impurity F; Enalaprilat Impurity F; Enalapril Related Compound F; MK-422 Impurity; N-[(S)-1-Carboxy-3-phenylpropyl]-L-alanyl-L-proline
EINECS	Contact for details

Quality Control

Every batch of Enalaprilat EP Impurity F is manufactured and controlled to meet the stringent requirements for pharmaceutical reference standards. Our quality system ensures compliance with relevant pharmacopoeial guidelines (EP/BP, USP). Comprehensive testing, including identification by spectroscopic methods (IR, NMR), purity assay by HPLC, and control of related substances and residual solvents, is performed. A detailed Certificate of Analysis (COA) with batch-specific data is provided with each 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). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions 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.