Description

Ceftaroline Fosamil Impurity 2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic Ceftaroline Fosamil by serving as a known impurity marker. It is primarily needed by pharmaceutical manufacturers, quality control laboratories, and research institutions engaged in drug development and analytical method validation.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ceftaroline Fosamil active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating high-performance liquid chromatography (HPLC), UPLC, and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity profiles and ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability testing of Ceftaroline Fosamil formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and control strategies.
• Research & Development: Serves as a key intermediate or impurity standard in synthetic chemistry research and metabolic studies related to cephalosporin antibiotics.

Basic Information

Product Name	Ceftaroline Fosamil Impurity 2
CAS No.	1240196-56-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ceftaroline Fosamil Related Compound 2; Ceftaroline Impurity 2; (6R,7R)-7-[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetamido]-3-[(4-{[(2R)-3-carboxy-1-{[(2R)-2-(phosphonooxy)propanoyl]amino}-1-oxopropan-2-yl]amino}-2,2-dimethyl-4-oxobutanoyl)oxymethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Ceftaroline Fosamil EP Impurity B; Ceftaroline Fosamil USP Impurity
EINECS	Contact for details

Quality Control

Our Ceftaroline Fosamil Impurity 2 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques like HPLC, NMR, and mass spectrometry. We support compliance with ICH guidelines and relevant pharmacopeial standards for impurity reference materials.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%
Total Impurities	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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