Description

Cephalexin Diketopiperazine CAS NO 59865-11-1 is a key pharmaceutical intermediate and degradation product of the β-lactam antibiotic Cephalexin. This compound is of significant importance for research, quality control, and the development of analytical methods within the pharmaceutical industry. It is primarily utilized by manufacturers and R&D laboratories involved in antibiotic production, stability studies, and impurity profiling to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for the identification and quantification of Cephalexin-related impurities in drug substances and finished products.
• Analytical Research & Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor drug degradation.
• Forced Degradation Studies: Used in stability testing to understand the degradation pathways of Cephalexin under various stress conditions (e.g., heat, humidity, pH).
• Process Chemistry & Impurity Control: Employed in the synthesis and purification stages of Cephalexin to monitor and control the formation of this specific diketopiperazine derivative.
• Academic & Institutional Research: Used in universities and research institutes for studies on β-lactam antibiotic stability, degradation kinetics, and metabolite identification.
• Quality Assurance/Quality Control (QA/QC): A vital component in the quality control laboratories of API manufacturers and finished dosage form producers to comply with ICH guidelines on impurities.

Basic Information

Product Name	Cephalexin Diketopiperazine
CAS No.	59865-11-1
Molecular Formula	C16H19N3O4S
Molecular Weight	349.41 g/mol
Synonyms	(6R,7R)-7-[[(2R)-2-Amino-2-phenylacetyl]amino]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid cyclic dimer; Cephalexin Dimer; Cephalexin DKP; Cephalexin Impurity D; Cephalexin Related Compound D; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2R)-2-amino-2-phenylacetyl]amino]-3-methyl-8-oxo-, (6R,7R)-, cyclic dimer
EINECS	Contact for details

Quality Control

Our Cephalexin Diketopiperazine is produced and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical analysis and research. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to maintain stability and purity.

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%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%

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