Description

Cephalexin S-Sulfoxide CAS NO 74708-55-7 is a key pharmaceutical intermediate and impurity reference standard derived from the β-lactam antibiotic cephalexin. This compound is of critical importance for quality control and research in the pharmaceutical industry, particularly in the development and manufacturing of cephalosporin antibiotics. It is primarily required by manufacturers and analytical laboratories for impurity profiling, method validation, and ensuring the purity and safety of final drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the S-sulfoxide impurity in cephalexin drug substances and finished products.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor degradation products.
• Quality Control & Assurance: Serves as a system suitability standard and for setting impurity limits in accordance with ICH Q3A/B guidelines.
• Process Chemistry Research: Used in studies to understand and mitigate oxidation pathways during the synthesis and storage of cephalexin.
• Regulatory Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs).
• Academic & Clinical Research: Employed in pharmacokinetic, metabolic, and degradation studies of cephalosporin antibiotics.

Basic Information

Product Name	Cephalexin S-Sulfoxide
CAS No.	74708-55-7
Molecular Formula	C16H17N3O5S
Molecular Weight	363.39 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 S-oxide; Cephalexin Sulfoxide; Cephalexin S-Oxide; Cephalexin Related Compound F (EP); Cephalexin Impurity F; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2R)-2-amino-2-phenylacetyl]amino]-3-methyl-8-oxo-, S-oxide, (6R,7R)-
EINECS	Contact for details

Quality Control

Our Cephalexin S-Sulfoxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identification by IR and NMR, and residual solvent analysis, to ensure it meets high-purity standards suitable for use as a reference material. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot, supporting compliance with ICH, USP, and EP guidelines.

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 prevent degradation from atmospheric moisture.

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.