Description

Ceftaroline Fosamil Impurity 10 is a designated impurity reference standard used in the analytical profiling and quality control of the antibiotic Ceftaroline Fosamil. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of cephalosporin antibiotics.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ceftaroline Fosamil API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Used to track the formation of this specific impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Aids in synthetic route optimization and degradation pathway studies during the drug development process.

Basic Information

Product Name	Ceftaroline Fosamil Impurity 10
CAS No.	1277090-03-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ceftaroline Related Compound; Ceftaroline Fosamil EP Impurity; Ceftaroline Fosamil USP Impurity; (6R,7R)-7-[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetamido]-3-[(4-{[(2R)-3,3-dimethyl-4-sulfanyliden-1-[(phosphonooxy)methyl]azetidin-2-yl]methyl}pyridin-1-ium-1-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate; Ceftaroline Impurity F (potential); Ceftaroline Process Impurity; Antibiotic Impurity Standard
EINECS	Contact for details

Quality Control

Our Ceftaroline Fosamil Impurity 10 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and accurate identification. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), and related substances. We support compliance with pharmaceutical standards (USP/EP/ICH) for impurity reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

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

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