Description

Ceftazidime Impurity B CAS NO 1236700-64-3 is a high-purity chemical reference standard used for the identification and quantification of a specific process-related impurity in the active pharmaceutical ingredient (API) Ceftazidime. This compound is critical for pharmaceutical quality control and regulatory compliance, ensuring the safety and efficacy of the final antibiotic product. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and research institutions involved in the development, production, and quality assurance of cephalosporin antibiotics.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Ceftazidime Impurity B in drug substance and drug product testing.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing of Ceftazidime API to ensure compliance with pharmacopeial monographs (e.g., USP, EP, BP).
• Stability Studies: Employed to monitor impurity levels in Ceftazidime formulations under various storage conditions over time.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., with FDA, EMA) for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to develop improved purification processes for Ceftazidime.

Basic Information

Product Name	Ceftazidime Impurity B
CAS No.	1236700-64-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2R,3R,4R,5R,6R)-6-[(2R)-2-[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-(1-carboxy-1-methylethoxy)iminoacetamido]-2-carboxyethyl]sulfanyl-3,4,5-trihydroxyoxane-2-carboxylic acid; Ceftazidime Related Compound B; Ceftazidime EP Impurity B; Ceftazidime USP Impurity B; (6R,7R)-7-[[(2Z)-2-(2-Amino-4-thiazolyl)-2-[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-8-oxo-3-[(1-pyridinio)methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate impurity; Des-pyridinium Ceftazidime
EINECS	Contact for details

Quality Control

Our Ceftazidime Impurity B is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. Certificates of Analysis (COA) with detailed chromatographic data are provided, supporting compliance with relevant pharmacopeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle the container with care to minimize exposure to atmospheric humidity.

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)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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