Description

Ceftaroline Fosamil Impurity 25 is a designated impurity standard used in the analytical profiling and quality control of the antibiotic Ceftaroline Fosamil. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It serves as a key reference material for method development, validation, and routine batch testing in the production of advanced cephalosporin antibiotics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Ceftaroline Fosamil active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to accurately identify and quantify this specific impurity.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to monitor the formation and levels of this impurity during forced degradation and long-term stability studies of Ceftaroline Fosamil.
• Process Chemistry & Optimization: Helps research and development (R&D) scientists identify and minimize the formation of this impurity during the API synthesis and purification processes.
• Pharmacopoeial Testing: May be employed as a system suitability or reference compound for testing in compliance with pharmacopoeial monographs (e.g., USP, EP).

Basic Information

Product Name	Ceftaroline Fosamil Impurity 25
CAS No.	51761-81-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-4-thiazolyl)-2-methoxyiminoacetyl]amino]-3-[(acetyloxy)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Ceftaroline Related Compound; Ceftaroline Fosamil Related Substance; TAK-599 Impurity; PPI-0903 Impurity
EINECS	Contact for details

Quality Control

Every batch of Ceftaroline Fosamil Impurity 25 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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