Description

Cefodizime Oxidation Impurity 1 is a critical pharmaceutical reference standard used for the quality control and analytical profiling of the antibiotic Cefodizime. This compound is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by identifying and quantifying oxidative degradation products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of cephalosporin antibiotics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Cefodizime oxidative degradation products in HPLC and LC-MS analysis.
• API Quality Control: Critical for setting impurity specifications and validating analytical methods during the manufacturing and release testing of Cefodizime sodium.
• Stability Studies: Used to monitor the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to determine API shelf-life and storage requirements.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Method Development & Validation: Serves as a key component in developing, optimizing, and validating chromatographic methods for impurity profiling.
• Research & Development: Utilized in R&D to study the degradation pathways of Cefodizime and to develop more stable formulations.

Basic Information

Product Name	Cefodizime Oxidation Impurity 1
CAS No.	111874-11-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-4-thiazolyl)-2-methoxyiminoacetyl]amino]-3-[[(5-carboxy-1-methyl-1H-pyrazol-4-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefodizime Impurity 1; Cefodizime Oxidative Degradant; Cefodizime Related Compound 1
EINECS	Contact for details

Quality Control

Every batch of Cefodizime Oxidation Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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