Description

Ceftaroline Fosamil Impurity 5 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 utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the synthesis, purification, and quality assurance of Ceftaroline Fosamil.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ceftaroline Fosamil active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive and specific analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical tool for in-process testing and release testing of Ceftaroline Fosamil to ensure it meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate understanding and control of the impurity profile.
• Process Chemistry Research: Used by chemists to study and optimize synthetic pathways to minimize the formation of this impurity.

Basic Information

Product Name	Ceftaroline Fosamil Impurity 5
CAS No.	1286218-68-5
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-(hydroxyimino)acetamido]-3-[(4-(1-methyl-4-pyridinio)-1,3-thiazol-2-yl]thio]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate benzenesulfonate monohydrate; Ceftaroline Impurity 5; Ceftaroline Fosamil Related Compound 5; TAK-599 Impurity 5; PPI-0903 Impurity 5
EINECS	Contact for details

Quality Control

Our Ceftaroline Fosamil Impurity 5 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data.

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 under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	Contact for details
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.