Description

Ceftaroline Fosamil Impurity 30 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 method development, validation, and stability studies within the pharmaceutical industry, particularly for cephalosporin antibiotic production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Ceftaroline Fosamil Impurity 30 in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Critical component for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine QC testing to ensure Ceftaroline Fosamil meets stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines) for impurity limits.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate thorough impurity control.
• Research & Development: Serves as a key impurity standard in synthetic route optimization and process chemistry research for cephalosporin antibiotics.

Basic Information

Product Name	Ceftaroline Fosamil Impurity 30
CAS No.	400827-58-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(5aR,6R)-6-[(1R)-1-Hydroxyethyl]-3-{[(5-methyl-2-thienyl)carbonyl]amino}-7-oxo-4-thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid; Ceftaroline Related Compound; Ceftaroline Fosamil Related Substance; TAK-599 Impurity; PPI-0903 Impurity; (5aR,6R,8R)-6-[(1R)-1-Hydroxyethyl]-3-{[(5-methyl-2-thienyl)carbonyl]amino}-7-oxo-4-thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid
EINECS	Contact for details

Quality Control

Our Ceftaroline Fosamil Impurity 30 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure the highest standards of 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 spectroscopic methods for structural confirmation. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.