Description

Enalapril Ep Impurity F Maleate is a high-purity reference standard critical for pharmaceutical research and quality control. This compound serves as a specified impurity in the analysis and validation of Enalapril Maleate, a widely prescribed ACE inhibitor. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry to ensure drug safety, efficacy, and regulatory compliance. The availability of this well-characterized impurity standard is fundamental for method development, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Enalapril Maleate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Critical component for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control and Assurance (QC/QA): Used in routine batch testing to ensure impurity levels are within the limits specified by pharmacopeial standards (USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research and Development: Used in synthetic chemistry research to understand degradation pathways and to develop robust purification processes for the API.

Basic Information

Product Name	Enalapril Ep Impurity F Maleate
CAS No.	76391-34-9
Molecular Formula	C24H32N2O9 • C4H4O4
Molecular Weight	492.52 g/mol (Free base: 492.52)
Synonyms	Enalapril EP Impurity F; (S)-1-[N-[(S)-1-Carboxy-3-phenylpropyl]alanyl]pyrrolidine, 2-ethyl butanoate, maleate salt; Enalapril Maleate Impurity F; Enalapril Related Compound F; Enalaprilat Ethyl Ester Maleate; Enalapril Ester Impurity; Enalapril EP Impurity F (Maleate); UNII-9M3H5WX2QI
EINECS	Contact for details

Quality Control

Our Enalapril Ep Impurity F Maleate is manufactured and controlled under a strict quality management system. Each batch undergoes comprehensive analytical testing, including chromatographic purity, identity confirmation, and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and analytical methods (typically HPLC). Our quality commitment aligns with the standards expected for pharmacopeial (USP/EP) impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. This product is hygroscopic (moisture-sensitive) and should be handled in a manner to minimize exposure to atmospheric humidity.

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 individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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