Description

Ceftaroline Fosamil Impurity 31 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 essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Ceftaroline Fosamil API and finished drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Ceftaroline Fosamil active pharmaceutical ingredient (API).
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation and levels of this specific impurity under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Quality Control & Batch Release: An essential component in the quality control laboratory for routine testing of API batches to ensure they meet stringent pharmacopeial (e.g., USP, EP) specifications.
• Regulatory Submissions: Provides necessary data on impurity identity and characterization for regulatory filings (e.g., ANDA, NDA, CTA) with agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during synthesis, enabling process optimization to minimize its generation.

Basic Information

Product Name	Ceftaroline Fosamil Impurity 31
CAS No.	1809412-65-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ceftaroline Related Compound 31; Ceftaroline Fosamil EP Impurity G; Ceftaroline Fosamil USP Impurity; (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 Fosamil Impurity; Ceftaroline Fosamil Process Impurity; TAK-599 Impurity 31; PPI-0903 Impurity
EINECS	Contact for details

Quality Control

Every batch of Ceftaroline Fosamil Impurity 31 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling 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) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccants or inert atmosphere packaging.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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