Description

Ramipril Diketopiperazine is a key pharmaceutical intermediate and impurity reference standard used in the synthesis and quality control of the antihypertensive drug Ramipril. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, research institutions, and analytical laboratories involved in cardiovascular drug development and production.

Application

• Primary use as a reference standard for impurity identification and quantification in Ramipril API and finished dosage forms.
• Critical pharmaceutical intermediate in the synthesis pathway of Ramipril.
• Essential material for analytical method development and validation (HPLC, LC-MS) in quality control laboratories.
• Used in stability studies to monitor degradation profiles of Ramipril under various conditions.
• Key component in regulatory compliance and documentation (e.g., for FDA, EMA submissions).
• Research reagent for studying the metabolism and pharmacokinetics of Ramipril and related ACE inhibitors.

Basic Information

Product Name	Ramipril Diketopiperazine
CAS No.	108731-95-9
Molecular Formula	C23H32N2O5
Molecular Weight	416.52 g/mol
Synonyms	(2S,3aS,6aS)-1-[(2S)-2-[[(1S)-1-Ethoxycarbonyl-3-phenylpropyl]amino]propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic Acid, Cyclic DKP; Ramipril DKP; Ramipril Cyclic Diketopiperazine; Ramipril Impurity D; Ramipril Degradation Product; Ramipril Related Compound D; 1,4-Diketopiperazine Derivative of Ramipril
EINECS	Contact for details

Quality Control

Our Ramipril Diketopiperazine is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for pharmaceutical impurity standards. Certificates of Analysis (COA) with detailed chromatographic data are provided and can be tailored to support specific pharmacopeial (USP, EP) methodologies.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a low-humidity environment to prevent degradation.

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 single unknown impurity ≤ 0.5%
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.