Description

Ceftibuten Related Impurity 8 is a high-purity chemical reference standard used for analytical and quality control purposes in the pharmaceutical industry. This compound is critical for ensuring the safety and efficacy of the antibiotic Ceftibuten by enabling the accurate identification, quantification, and control of its related substances. It is an essential material for analytical chemists, quality assurance laboratories, and research institutions involved in pharmaceutical development and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Ceftibuten.
• Method Development and Validation: Crucial for developing and validating analytical methods, particularly HPLC and UPLC, for impurity profiling.
• Quality Control (QC) Testing: Used in routine QC testing of Ceftibuten Active Pharmaceutical Ingredient (API) and finished drug products to monitor impurity levels against ICH guidelines.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs).
• Stability Studies: Employed to identify and track degradation products formed during the stability testing of Ceftibuten formulations.
• Research and Development: Serves as a key impurity for synthetic route optimization and process chemistry research in antibiotic development.

Basic Information

Product Name	Ceftibuten Related Impurity 8
CAS No.	174761-17-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ceftibuten Impurity 8; Ceftibuten EP Impurity C; (6R,7R)-7-[(Z)-2-(2-Amino-4-thiazolyl)-4-carboxy-2-butenoylamino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Ceftibuten Related Compound C; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 7-[[(2Z)-2-(2-amino-4-thiazolyl)-4-carboxy-1-oxo-2-buten-1-yl]amino]-8-oxo-, (6R,7R)-; Ceftibuten Process Impurity
EINECS	Contact for details

Quality Control

Our Ceftibuten Related Impurity 8 is manufactured and tested under strict quality management systems. Each batch is characterized and qualified using advanced analytical techniques to ensure high purity and accurate identification, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity, and related substances. Our quality commitment aligns with the standards expected for materials used in GMP environments and regulatory filings.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (typically 15-25°C) in a dry environment. For long-term storage, consider storing desiccated at -20°C. Handle the material under appropriate laboratory conditions to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%

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