Description

Ceftaroline Fosamil Impurity 1 is a specified impurity and degradation product of the fifth-generation cephalosporin antibiotic, Ceftaroline Fosamil. This high-purity reference standard is critical for pharmaceutical research, development, and quality control processes. It is primarily utilized by analytical laboratories and pharmaceutical manufacturers to ensure the safety, efficacy, and regulatory compliance of Ceftaroline Fosamil API and its finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Ceftaroline Fosamil Impurity 1 in active pharmaceutical ingredient (API) and drug product analysis.
• Method Development & Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for Ceftaroline Fosamil.
• Stability Studies: Used to monitor impurity profiles during forced degradation and long-term stability studies of Ceftaroline Fosamil to establish shelf-life.
• Quality Control (QC) Testing: A critical component in the routine QC release testing of Ceftaroline Fosamil batches to ensure compliance with pharmacopeial (e.g., USP, EP) and ICH guidelines.
• Regulatory Submissions: Provides necessary data on impurity characterization and control strategies for regulatory filings (e.g., FDA, EMA).
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Ceftaroline Fosamil.

Basic Information

Item	Details
Product Name	Ceftaroline Fosamil Impurity 1
CAS No.	1286218-72-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(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; Ceftaroline Impurity 1; Ceftaroline Related Compound 1; TAK-599 Impurity 1; PPI-0903 Impurity
EINECS	Contact for details

Quality Control

Our Ceftaroline Fosamil Impurity 1 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies
Water Content (KF)	≤ 5.0%
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.