Description

Ceftaroline Fosamil Impurity 8 is a designated impurity of the fifth-generation cephalosporin antibiotic, Ceftaroline Fosamil. 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 (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product purity, safety, and compliance with stringent pharmacopeial standards.

Application

• Primary use as a certified reference standard for the identification and quantification of Ceftaroline Fosamil Impurity 8 in API and finished drug products.
• Essential for method development and validation in analytical techniques such as HPLC and UPLC.
• Critical component in stability studies to monitor impurity profiles and ensure drug product shelf-life.
• Used in regulatory submissions to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Supports pharmaceutical research into the degradation pathways and metabolism of Ceftaroline Fosamil.
• Employed in quality assurance/quality control (QA/QC) laboratories for routine batch release testing.

Basic Information

Product Name	Ceftaroline Fosamil Impurity 8
CAS No.	1286218-63-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(5aR,6R,7R,8Z)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[[(1E)-1-(2-hydroxyethyl)-3-oxoprop-1-en-1-yl]thio]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Ceftaroline Related Compound; Ceftaroline Fosamil EP Impurity; Ceftaroline Fosamil USP Impurity; Ceftaroline Impurity F (Potential); Desfuroylceftaroline E-isomer; TAK-599 Impurity
EINECS	Contact for details

Quality Control

Our Ceftaroline Fosamil Impurity 8 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for use as a reference material. Each batch is characterized and qualified using advanced techniques including HPLC, MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with ICH guidelines and pharmacopeial requirements.

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 kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to Off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%
Total Impurities	≤ 5.0%
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.