Description

Ceftaroline Fosamil Impurity 3 is a designated impurity of the fifth-generation cephalosporin antibiotic, Ceftaroline Fosamil. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and validation of Ceftaroline Fosamil API and its finished dosage forms.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Ceftaroline Fosamil Active Pharmaceutical Ingredient (API).
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in quality control laboratories.
• Critical component in stability studies to monitor impurity profiles and ensure drug product shelf-life.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• Supports pharmacopoeial testing to meet standards set by USP, EP, or other pharmacopoeias.
• Valuable for research and development of Ceftaroline Fosamil, including process chemistry optimization.

Basic Information

Product Name	Ceftaroline Fosamil Impurity 3
CAS No.	1286218-70-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ceftaroline Related Compound 3; Ceftaroline Fosamil EP Impurity C; Ceftaroline Fosamil USP Impurity 3; (6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(4-carbamoylpyridin-1-ium-1-yl)methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate Fosamil Impurity; TAK-599 Impurity 3; PPI-0903 Impurity
EINECS	Contact for details

Quality Control

Every batch of Ceftaroline Fosamil Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.