Description

Ceftaroline Impurity 1 CAS NO 1240343-85-4 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 the safety, efficacy, and regulatory compliance of the final drug product. It serves as a key marker for identifying and quantifying process-related impurities during development and production. Professionals in pharmaceutical R&D, quality assurance, and analytical chemistry rely on this standard for method validation and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of Ceftaroline Fosamil API and finished formulations.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to separate, identify, and quantify impurities.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure product specifications are met according to ICH guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files.
• Research & Development: Aids in process chemistry optimization to understand and minimize impurity formation during synthesis.

Basic Information

Product Name	Ceftaroline Impurity 1
CAS No.	1240343-85-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(5aR,6R,8R,9R)-9-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino]-8-oxo-3-[[(1R)-1-(phosphonooxy)ethyl]-3,6,9,11a-tetrahydro-3,12-dithia-1,4,7,10-tetraazacyclododeca-5,8-diene-6-carboxylic acid; Ceftaroline Related Compound; Ceftaroline Fosamil Impurity; TAK-599 Impurity; PPI-0903 Impurity
EINECS	Contact for details

Quality Control

Every batch of Ceftaroline Impurity 1 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and mass spectrometry, to ensure high purity and accurate identification for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. We support compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 95.0%
Assay	≥ 98.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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