Description

Ceftizoxime Impurity 20 is a high-purity chemical reference standard, specifically identified as an impurity of the third-generation cephalosporin antibiotic, Ceftizoxime. This compound is critical for pharmaceutical research and development, serving as a key marker for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API). It is primarily required by analytical laboratories and pharmaceutical manufacturers engaged in method development, stability studies, and rigorous quality control processes to meet global regulatory standards.

Application

• Primary use as a certified reference standard for the identification and quantification of Ceftizoxime Impurity 20 in Ceftizoxime API and finished drug products.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in pharmaceutical quality control laboratories.
• Critical component in stability studies and forced degradation studies to monitor impurity profiles over time.
• Used in regulatory compliance and submission to agencies like the FDA, EMA, and PMDA, providing necessary impurity data.
• Supports research and development of Ceftizoxime, including process chemistry optimization and impurity synthesis pathways.
• Acts as a system suitability test component in chromatographic assays to ensure analytical instrument performance.

Basic Information

Product Name	Ceftizoxime Impurity 20
CAS No.	33477-97-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-8-oxo-3-[(1,2,3-thiadiazol-5-ylsulfanyl)methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Ceftizoxime Related Compound; Ceftizoxime EP Impurity; Ceftizoxime USP Impurity; 7β-[2-(2-Aminothiazol-4-yl)-2-methoxyiminoacetamido]-3-(1,2,3-thiadiazol-5-ylthiomethyl)-3-cephem-4-carboxylic acid
EINECS	Contact for details

Quality Control

Our Ceftizoxime Impurity 20 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation by spectroscopic methods (IR, NMR), to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming its suitability for use as a reference standard.

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 material is hygroscopic (moisture-sensitive) and must be handled in a dry environment to prevent degradation. For long-term stability, consider storage under inert atmosphere.

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.