Description

Cephalexin Diketopiperazine Monoacid (Mixture Of Diastereomers) is a key chemical intermediate and impurity reference standard derived from the β-lactam antibiotic cephalexin. This compound is of significant importance in pharmaceutical research and development for the analysis, control, and study of cephalexin-related substances. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on antibiotic quality control, process chemistry, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in cephalexin active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for cephalexin purity and stability testing.
• Process Chemistry Research: Employed in studies investigating the degradation pathways, stability profiles, and formation mechanisms of diketopiperazine derivatives during cephalexin synthesis and storage.
• Quality Control & Assurance (QC/QA): Essential for in-house quality control laboratories to ensure cephalexin batches comply with pharmacopeial standards (e.g., USP, EP, JP) regarding specified and unspecified impurities.
• Regulatory Submissions: Provides necessary data and reference samples for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of product-related impurities.
• Academic & Clinical Research: Utilized in scientific studies exploring the structure-activity relationships, metabolism, and potential biological activities of cephalexin degradation products.

Basic Information

Product Name	Cephalexin Diketopiperazine Monoacid (Mixture Of Diastereomers)
CAS No.	1323247-65-9
Molecular Formula	C16H19N3O4S
Molecular Weight	349.40 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 Diketopiperazine Derivative; Cephalexin DKP Acid; Cephalexin Diketopiperazine Impurity; Cephalexin Related Compound; Diketopiperazine of Cephalexin; Ceph DKP Monoacid; Cephalexin Degradation Product; C16H19N3O4S (Diketopiperazine Form)
EINECS	Contact for details

Quality Control

Our Cephalexin Diketopiperazine Monoacid is produced and handled under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the high standards required for use as a reference material. Certificates of Analysis (COA) detailing batch-specific results from techniques such as HPLC, NMR, and MS are provided. We support compliance with cGMP and ICH Q3B(R2) guidelines for impurity qualification.

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) and light-sensitive; therefore, containers must be kept sealed in a desiccated environment and handled under conditions that minimize exposure to ambient light and humidity to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC, Area %)	≥ 95.0% (sum of diastereomers)
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH limits
Diastereomer Ratio (HPLC)	Reported on COA

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