Description

Ceftaroline Fosamil Impurity 18 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, stability studies, and quality control testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of the final drug product. The availability of a well-characterized impurity standard is essential for compliance with stringent global regulatory requirements.

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 chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of Ceftaroline Fosamil.
• Quality Control & Batch Release: A critical component in the quality control laboratory for routine testing and release of API and drug product batches against established specifications.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity characterization and control.
• Research & Development: Used in synthetic chemistry R&D to study the formation and fate of this impurity during the manufacturing process.

Basic Information

Product Name	Ceftaroline Fosamil Impurity 18
CAS No.	953037-68-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ceftaroline Related Compound 18; Ceftaroline Fosamil EP Impurity 18; Ceftaroline Fosamil USP Impurity 18; (6R,7R)-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(4-pyridin-1-iumylmethyl)-1,3-thiazol-2-yl]sulfanyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate; Ceftaroline Fosamil Process Impurity; Ceftaroline Impurity F18; TAK-599 Impurity 18
EINECS	Contact for details

Quality Control

Our Ceftaroline Fosamil Impurity 18 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from multiple orthogonal techniques, including HPLC for purity and related substances, NMR and MS for structural confirmation, and KF for water content. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
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.