Description

Moexipril Diketopiperazine is a key pharmaceutical intermediate and impurity standard, specifically the diketopiperazine derivative of the ACE inhibitor Moexipril. This compound is critical for analytical method development, quality control, and regulatory compliance in the production of cardiovascular drugs. It is primarily utilized by pharmaceutical manufacturers, research institutions, and quality assurance laboratories involved in the synthesis and analysis of Moexipril and related active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC, LC-MS, and other analytical methods to ensure drug purity and meet ICH guidelines.
• API Synthesis Intermediate: Used in the research, development, and scale-up synthesis of the antihypertensive drug Moexipril hydrochloride.
• Quality Control & Assurance: Essential for establishing and validating impurity profiles, stability studies, and release testing of Moexipril-based drug products.
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing characterized impurity data for health authorities like the FDA and EMA.
• Pharmacological Research: Employed in metabolic and degradation pathway studies to understand the behavior of Moexipril in formulations and biological systems.
• Contract Manufacturing & Testing: Supplied to CDMOs and analytical service labs specializing in cardiovascular drug development and testing.

Basic Information

Product Name	Moexipril Diketopiperazine
CAS No.	103733-51-3
Molecular Formula	C27H34N2O7
Molecular Weight	498.57 g/mol
Synonyms	(3S,6S,11aS)-6-[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]-5-oxo-1,2,3,4,6,7,8,9,10,11a-decahydrocyclopenta[b]pyrazino[1,2-a]pyrazine-3-carboxylic Acid; Moexipril DKP; Moexipril Cyclization Product; Moexipril Impurity; Moexipril Related Compound A; SQ 31,389 Diketopiperazine; SQ 31389 DKP
EINECS	Contact for details

Quality Control

Our Moexipril Diketopiperazine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting compliance with specified parameters. We support compliance with ICH Q3A, Q3B, and USP guidelines for impurities.

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); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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