Description

Ceftaroline Fosamil Impurity 6 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) by serving as a reference marker 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 & Batch Release Testing: Employed in routine QC laboratories to monitor impurity levels against established pharmacopeial or internal specifications.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Research & Development: Utilized in pharmaceutical R&D to understand the degradation pathways and chemical behavior of Ceftaroline Fosamil.

Basic Information

Product Name	Ceftaroline Fosamil Impurity 6
CAS No.	953037-71-3
Molecular Formula	C22H21N8O8S2+ • C6H5O7S- • H2O
Molecular Weight	Contact for details
Synonyms	(6R,7R)-7-[(2Z)-2-(5-Amino-1,2,4-thiadiazol-3-yl)-2-(methoxyimino)acetamido]-3-[(4-carbamoylpyridin-1-ium-1-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate 4-sulfobenzoate monohydrate; Ceftaroline Impurity 6; Ceftaroline Fosamil Related Compound 6; TAK-599 Impurity 6; PPI-0903 Impurity 6
EINECS	Contact for details

Quality Control

Every batch of Ceftaroline Fosamil Impurity 6 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support our global clientele in meeting regulatory requirements from the FDA, ICH, and other international bodies.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 2.0%
Water Content (KF)	Contact for details
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.