Description

Ceftibuten Related Impurity 3 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 and quantification of process-related impurities. It is an essential material for research and development laboratories, quality assurance units, and regulatory compliance teams. The product is supplied with comprehensive analytical data to support method validation and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Ceftibuten impurities in active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to monitor impurity levels and ensure Ceftibuten API meets pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance & Submission: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity samples for stability studies and specification setting.
• Research on Degradation Pathways: Utilized in forced degradation studies to understand the stability profile and degradation chemistry of Ceftibuten.
• Calibration of Analytical Instruments: Serves as a precise calibrant to ensure the accuracy and reproducibility of analytical systems used in pharmaceutical analysis.

Basic Information

Product Name	Ceftibuten Related Impurity 3
CAS No.	1140311-29-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ceftibuten Impurity 3; Ceftibuten EP Impurity C; Ceftibuten Related Compound 3; (6R,7R)-7-[[(2Z)-2-(2-Amino-4-thiazolyl)-4-carboxy-2-butenoyl]amino]-8-oxo-3-[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Deriv. of Ceftibuten; Ceftibuten Process Impurity
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Each batch of Ceftibuten Related Impurity 3 is characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC, to confirm identity and purity. Certificates of Analysis (COA) are provided, detailing batch-specific results for purity, impurities, and other critical parameters. Our quality system is designed to support cGMP requirements for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing desiccated under inert atmosphere.

Specification

Item	Specification
Appearance	White to Off-white Powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual Unknown Impurity: ≤ 1.0% Total Impurities: ≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C Guidelines
Water Content (KF)	≤ 5.0%

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