Description

Cephalexin Sulfoxide 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 & development within the pharmaceutical industry, particularly for ensuring the purity and efficacy of cephalosporin-based medications. It is primarily utilized by manufacturers of active pharmaceutical ingredients (APIs), analytical laboratories, and research institutions focused on antibiotic development and degradation studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of cephalexin sulfoxide in drug substances and finished products via HPLC, UPLC, or LC-MS analysis.
• API Manufacturing & Impurity Profiling: Used in the research, development, and quality control processes during the synthesis of Cephalexin to monitor and control oxidative degradation.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating stability-indicating analytical methods for cephalosporin antibiotics.
• Stability Studies: Employed in forced degradation studies to understand the stability profile of cephalexin under various stress conditions (e.g., oxidative stress).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurities for drug master files (DMFs) and investigational new drug (IND) applications.
• Academic & Clinical Research: Used in university and institutional research investigating the metabolism, degradation pathways, and structure-activity relationships of β-lactam antibiotics.

Basic Information

Product Name	Cephalexin Sulfoxide
CAS No.	56193-21-6
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 5-oxide; Cefalexin Sulfoxide; Cephalexin S-Oxide; Cephalexin Impurity F (Sulfoxide); 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2R)-2-amino-2-phenylacetyl]amino]-3-methyl-8-oxo-, 5-oxide, (6R,7R)-; Cephalexin Related Compound F
EINECS	Contact for details

Quality Control

Our Cephalexin Sulfoxide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets exacting standards suitable for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment. We support compliance with ICH guidelines for impurities and can supply material characterized for use in regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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