Description

Ceftizoxime S-Oxide Impurity is a designated impurity standard used in the analytical profiling and quality control of the antibiotic Ceftizoxime. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the S-Oxide impurity in Ceftizoxime API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC or UPLC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Ceftizoxime complies with pharmacopeial limits for specified impurities (e.g., ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., oxidative stress) as part of forced degradation and shelf-life studies.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity characterization data required by agencies like the FDA and EMA.
• Research & Development: Aids in synthetic route optimization and impurity fate and tolerance studies during the drug development process.

Basic Information

Product Name	Ceftizoxime S-Oxide Impurity
CAS No.	79226-66-7
Molecular Formula	C13H13N5O6S2
Molecular Weight	407.41 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-8-oxo-3-[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid S-Oxide; Ceftizoxime S-Oxide; Ceftizoxime Sulfoxide; Ceftizoxime Impurity (S-Oxide); FK-749 S-Oxide; 7β-[2-(2-Aminothiazol-4-yl)glyoxylamido]-3-[[(2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]ceph-3-em-4-carboxylic Acid S-Oxide
EINECS	Contact for details

Quality Control

Our Ceftizoxime S-Oxide Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, related substances, and residual solvents, ensuring traceability and compliance with ICH guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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