Description

Ceftaroline 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 efficacy of the antibiotic ceftaroline fosamil during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments. The material is essential for method validation, impurity profiling, and meeting stringent pharmacopeial compliance standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quantitative and qualitative analysis of Ceftaroline Fosamil Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component in developing and validating chromatographic methods for impurity identification and separation.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor and control impurity levels, ensuring batches comply with International Conference on Harmonisation (ICH) guidelines and regulatory specifications.
• Stability Studies: Used to identify and quantify degradation products that may form under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to agencies like the FDA and EMA.
• Research & Development: Facilitates studies on the metabolism, degradation pathways, and chemical behavior of ceftaroline-related compounds.

Basic Information

Product Name	Ceftaroline Impurity 2
CAS No.	700803-62-9
Molecular Formula	C20H20N8O8S2
Molecular Weight	564.55 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino]-3-[(4-carbamoylpyridin-1-ium-1-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate; Ceftaroline Related Compound; Ceftaroline Fosamil Impurity; (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-methoxyiminoacetamido]-3-(4-carbamoylpyridinio)methyl-3-cephem-4-carboxylate; TAK-599 Impurity; PPI-0903 Impurity
EINECS	Contact for details

Quality Control

Every batch of Ceftaroline Impurity 2 is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our standard specification aligns with the requirements for pharmaceutical impurity reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, related substances, water content (KF), and residual solvents. We support compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines.

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. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
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.