Description

Ceftazidime Impurity A is a specified impurity and degradation product of the broad-spectrum cephalosporin antibiotic, Ceftazidime. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development, stability studies, and quality control testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Ceftazidime drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ceftazidime Impurity A in drug substances and products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or other chromatographic methods for impurity profiling.
• Stability Indicating Method: Employed in forced degradation studies to monitor the formation of this specific impurity under various stress conditions.
• Quality Control & Batch Release: Critical for setting impurity specifications and ensuring batch-to-batch consistency in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections) by providing impurity characterization data.
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Ceftazidime.

Basic Information

Product Name	Ceftazidime Impurity A
CAS No.	1000980-60-8
Molecular Formula	C22H22N6O7S2
Molecular Weight	546.58 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Aminothiazol-4-yl)-2-(1-carboxy-1-methylethoxy)iminoacetyl]amino]-8-oxo-3-(pyridin-1-ium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate; Ceftazidime Pyridinium Impurity; Ceftazidime Related Compound A; (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-(2-carboxypropan-2-yloxyimino)acetamido]-8-oxo-3-(pyridin-1-ium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate; Ceftazidime EP Impurity A; Ceftazidime USP Impurity A
EINECS	Contact for details

Quality Control

Our Ceftazidime Impurity A is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and accurate identification. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results for identity, purity, and related substances by validated methods such as HPLC and NMR. The material is suitable for use as a pharmaceutical reference standard in compliance with current regulatory expectations for impurity characterization.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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