Description

Ceftaroline Fosamil Impurity 7 is a high-purity reference standard used in the analytical profiling and quality control of the antibiotic Ceftaroline Fosamil. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying process-related impurities. It is an essential material for analytical method development, validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Ceftaroline Fosamil Impurity 7 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): An essential component in routine QC testing to monitor impurity levels and ensure API purity meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this specific impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and improve manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Ceftaroline Fosamil Impurity 7
CAS No.	1286218-64-1
Molecular Formula	C22H21N8O8S2+ • C6H6O7S- • H2O
Molecular Weight	Contact for details
Synonyms	(5aR,6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[[4-(1-methyl-6-oxo-1,6-dihydropyridin-3-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid fosamil impurity 7; Ceftaroline Fosamil Related Compound 7; TAK-599 Impurity 7; PPI-0903 Impurity 7; (6R,7R)-7-[(2Z)-2-(2-Aminothiazol-4-yl)-2-(methoxyimino)acetamido]-3-[[[4-(1-methyl-6-oxo-1,6-dihydropyridin-3-yl)sulfanyl]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid ester with (2R)-2-[(phosphonooxy)methyl]-2-(1H-1,2,3-triazol-4-yl)acetic acid
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Each batch of Ceftaroline Fosamil Impurity 7 is characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC, to confirm identity and purity. We adhere to strict quality management systems, and comprehensive Certificates of Analysis (COA) detailing purity, assay, and impurity profiles are available upon request.

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 dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Assay	≥ 90.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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