Description

Ceftaroline Fosamil Impurity 9 is a designated impurity 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) during development and manufacturing. It is an essential reference material for pharmaceutical R&D laboratories, quality assurance (QA) departments, and regulatory compliance teams involved in the production of cephalosporin antibiotics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Ceftaroline Fosamil Impurity 9 in API and finished drug products.
• Analytical Method Development & Validation: Critical component for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial limits.
• Regulatory Compliance & Filings: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, humidity, light) as part of drug stability testing.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Ceftaroline Fosamil.

Basic Information

Item	Details
Product Name	Ceftaroline Fosamil Impurity 9
CAS No.	1277090-04-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(5aR,6R)-6-[(1R)-1-Hydroxyethyl]-3-{[(4-methyl-1,3-thiazol-2-yl)thio]methyl}-7-oxo-4-thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid 4-(1-Methylethyl)-1,3-thiazol-2-yl Ester; Ceftaroline Fosamil Related Compound; Ceftaroline Impurity; Ceftaroline Fosamil EP Impurity; Ceftaroline Fosamil USP Impurity; Zinforo Impurity
EINECS	Contact for details

Quality Control

Our Ceftaroline Fosamil Impurity 9 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, LC-MS, and NMR to confirm identity and purity. We provide full traceability and a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality standards are designed to meet the rigorous requirements of pharmaceutical impurity standards for use in regulatory submissions and cGMP environments.

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). This material is hygroscopic (moisture-sensitive) and must be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0%; Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w

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