Description

Lisinopril S,S,S-Diketopiperazine is a key synthetic intermediate and impurity standard in the production of the widely prescribed antihypertensive drug, Lisinopril. This high-purity compound is critical for ensuring the quality, safety, and efficacy of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers and analytical laboratories for process development, quality control, and regulatory compliance.

Application

• Pharmaceutical Intermediate: A crucial building block in the multi-step synthesis of the ACE inhibitor Lisinopril.
• Reference Standard: Used as an analytical standard in HPLC, LC-MS, and other chromatographic methods for impurity profiling and method validation.
• Process Research & Development (R&D): Essential for optimizing synthetic routes and scaling up production processes in pharmaceutical R&D.
• Quality Control (QC) Testing: Employed to identify, quantify, and control this specific impurity in Lisinopril API batches to meet pharmacopeial specifications (e.g., USP, EP).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to monitor the formation of degradation products in Lisinopril formulations under various storage conditions.

Basic Information

Product Name	Lisinopril S,S,S-Diketopiperazine
CAS No.	328385-86-0
Molecular Formula	C22H32N4O5
Molecular Weight	432.52 g/mol
Synonyms	(4S)-4-[[(1S)-1-Carboxy-3-phenylpropyl]amino]-2,3,4,5,6,7-hexahydro-1H-azepino[3,2,1-hi]indole-1,3,8-trione; Lisinopril Diketopiperazine Impurity; Lisinopril DKP; Lisinopril Impurity F (EP); Lisinopril Related Compound F (USP); 1,3,8-Trioxo-2,3,6,7-tetrahydro-1H-azepino[3,2,1-hi]indole-4-carboxylic acid derivative; S,S,S-Lisinopril Diketopiperazine
EINECS	Contact for details

Quality Control

Our Lisinopril S,S,S-Diketopiperazine is manufactured under strict quality management systems. Each batch is subjected to rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical applications. Certificates of Analysis (COA) with detailed chromatographic data are provided and specifications can be aligned with pharmacopeial requirements (USP, EP) upon request.

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 nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

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.