Description

Ceftizoxime Impurity 8 is a designated impurity of the third-generation cephalosporin antibiotic, Ceftizoxime. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of the active pharmaceutical ingredient. It is primarily required by analytical chemists, quality assurance professionals, and regulatory affairs specialists within the pharmaceutical industry to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of Ceftizoxime Impurity 8 in drug substances and products.
• Essential for method development and validation in analytical laboratories using HPLC, UPLC, or LC-MS techniques.
• Critical component in stability studies and impurity profiling to monitor degradation pathways of Ceftizoxime.
• Used in regulatory submissions (e.g., ANDA, NDA) to establish impurity limits and specifications.
• Supports research and development of Ceftizoxime manufacturing processes and purification methods.
• Acts as a calibration standard for ensuring the accuracy and precision of analytical instrumentation.
• Utilized in pharmacopeial testing to comply with USP, EP, or other international monograph requirements.

Basic Information

Item	Details
Product Name	Ceftizoxime Impurity 8
CAS No.	68350-06-1
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-(methoxyimino)acetamido]-3-(1,2,3-thiadiazol-5-ylthiomethyl)-3-cephem-4-carboxylic Acid
EINECS	Contact for details

Quality Control

Every batch of Ceftizoxime Impurity 8 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing to ensure high purity and identity, aligning with the expectations for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for purity, identity, and other critical parameters. We support compliance with USP, EP, and ICH guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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