Description

Ceftibuten Related Impurity 9 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the purity, safety, and efficacy of the third-generation cephalosporin antibiotic, Ceftibuten, by enabling the accurate identification and quantification of process-related impurities. It is an essential material for analytical chemists and quality assurance professionals working in pharmaceutical R&D, quality control laboratories, and regulatory affairs, where precise impurity profiling is mandatory for regulatory submissions and batch release.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the calibration of analytical instruments (HPLC, LC-MS) used in impurity profiling of Ceftibuten API and finished drug products.
• Method Development and Validation: Used in the development, optimization, and validation of chromatographic methods for the separation and detection of specific impurities in Ceftibuten.
• Quality Control and Batch Release: Employed in routine QC testing to monitor and control the levels of Related Impurity 9 in commercial batches of Ceftibuten, ensuring compliance with pharmacopoeial limits (e.g., USP, EP).
• Stability Studies: A key component in forced degradation and long-term stability studies to identify and track impurity formation under various stress conditions.
• Regulatory Compliance and Filing: Provides essential data for regulatory documentation (e.g., CMC sections of IND/NDA/ANDA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in synthetic chemistry research to understand the formation pathways of this impurity and to develop optimized manufacturing processes that minimize its generation.

Basic Information

Product Name	Ceftibuten Related Impurity 9
CAS No.	103054-27-9
Molecular Formula	C15H14N4O6S2
Molecular Weight	410.42 g/mol
Synonyms	(6R,7R)-7-[(Z)-2-(2-Amino-4-thiazolyl)-4-carboxy-2-butenoylamino]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Ceftibuten Impurity 9; Ceftibuten EP Impurity C; (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-(carboxymethoxyimino)acetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (Isomer related to Ceftibuten); 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Derivative
EINECS	Contact for details

Quality Control

Every batch of Ceftibuten Related Impurity 9 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability. Our quality commitment aligns with cGMP principles to support our customers' regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccant use within the primary container.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.2%

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