Description

Enalapril Diketopiperazine is a key pharmaceutical intermediate and impurity reference standard derived from the angiotensin-converting enzyme (ACE) inhibitor, Enalapril. This compound is of critical importance for ensuring the quality, safety, and efficacy of Enalapril-based drug products through rigorous analytical control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Enalapril Maleate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor degradation pathways in Enalapril formulations.
• Pharmaceutical Research: Serves as a critical intermediate in studies investigating the metabolism, degradation profile, and synthesis pathways of Enalapril and related compounds.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopoeial specifications (USP, EP, BP).
• Regulatory Compliance & Filings: Provides necessary data for regulatory submissions (e.g., ANDA, NDA) to demonstrate comprehensive impurity profiling and control strategies.

Basic Information

Product Name	Enalapril Diketopiperazine
CAS No.	115729-52-7
Molecular Formula	C16H22N2O3
Molecular Weight	290.36 g/mol
Synonyms	(S,S)-2,6-Dioxo-3,7-diphenyl-1,4-diazabicyclo[4.4.0]decane; Enalapril DKP; Enalapril Cyclic Diketopiperazine; Enalapril Impurity D; Enalapril Related Compound D; 1,4-Diazabicyclo[4.4.0]decane-2,6-dione, 3,7-diphenyl-, (3S,7S)-; LK 422 DKP
EINECS	Contact for details

Quality Control

Our Enalapril Diketopiperazine is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with in-house specifications aligned with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent oxidation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.