Description

Ceftazidime Oxide Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of the antibiotic ceftazidime, ensuring the safety and efficacy of the final pharmaceutical product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Ceftazidime Oxide in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods for impurity analysis in compliance with ICH guidelines.
• Quality Control & Assurance: Serves as a critical component in the quality control workflow of ceftazidime manufacturing to monitor and control impurity levels.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data for impurity characterization and specification setting.
• Stability Studies: Employed in forced degradation and long-term stability studies of ceftazidime to understand its degradation pathways.
• Research & Development: Used in academic and industrial R&D for studying the chemical behavior, synthesis pathways, and metabolism of cephalosporin antibiotics.

Basic Information

Product Name	Ceftazidime Oxide Impurity
CAS No.	1301254-48-7
Molecular Formula	C22H22N6O7S2
Molecular Weight	546.58 g/mol
Synonyms	(6R,7R)-7-[[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-(2-carboxypropan-2-yloxyimino)acetyl]amino]-8-oxo-3-(pyridin-1-ium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate; Ceftazidime N-Oxide; Ceftazidime Impurity O (Oxide); Ceftazidime Related Compound O; 1-[[(6R,7R)-7-[[(2Z)-2-(2-Amino-4-thiazolyl)-2-[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]pyridinium Oxide
EINECS	Contact for details

Quality Control

Our Ceftazidime Oxide Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance.

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 in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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