Description

Ceftibuten Related Impurity 1 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 antibiotic Ceftibuten by serving as a known marker for identification and quantification of a specific process-related impurity. It is an essential material for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D and regulatory compliance. The availability of this well-characterized impurity standard is fundamental for meeting stringent pharmacopeial requirements and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Ceftibuten impurity profiles in accordance with ICH guidelines.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for Ceftibuten analysis.
• Quality Control & Batch Release Testing: Used in-house by API manufacturers and finished dosage form producers to monitor and control impurity levels during production.
• Regulatory Compliance & Submission: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing data on impurity characterization and control strategies.
• Stability Studies: Employed to track the formation of this specific impurity over time under various storage conditions as part of drug product stability testing.
• Research & Process Chemistry: Aids in understanding the degradation pathways and synthesis by-products of Ceftibuten, enabling process optimization.

Basic Information

Product Name	Ceftibuten Related Impurity 1
CAS No.	102199-53-1
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-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; Ceftibuten Impurity 1; Ceftibuten EP Impurity A; Ceftibuten USP Related Compound A; (Z)-7β-[(Z)-2-(2-Aminothiazol-4-yl)-2-pent-2-enoylaminoacetamido]-3-cephem-4-carboxylic Acid (isomer related); 102199-53-1; Ceftibuten Related Substance A
EINECS	Contact for details

Quality Control

Every batch of Ceftibuten Related Impurity 1 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing to ensure identity, purity, and consistency, aligning with current pharmacopeial expectations (e.g., USP, EP) and ICH Q3A/B guidelines for impurities. A comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic techniques is provided with each shipment to support your quality and regulatory needs.

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 CoA. This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%

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