Description

Ceftazidime Ep Impurity C Chloride is a high-purity chemical reference standard, specifically identified as an impurity of the broad-spectrum antibiotic Ceftazidime. This compound is critical for pharmaceutical research, development, and quality control, enabling the accurate identification, quantification, and monitoring of this specific impurity during drug manufacturing. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable reference standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Ceftazidime Ep Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC) assays.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor impurity profiles and ensure Ceftazidime batches meet stringent pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Employed to track the formation and levels of this impurity over time under various storage conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing purer synthesis routes for Ceftazidime.

Basic Information

Product Name	Ceftazidime Ep Impurity C Chloride
CAS No.	78931-25-6
Molecular Formula	C22H21N6O7S2 · HCl
Molecular Weight	Approx. 597.03 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 chloride; Ceftazidime Impurity C (Chloride Salt); Ceftazidime Related Compound C; (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-(1-carboxy-1-methylethoxyimino)acetamido]-3-(1-pyridiniomethyl)ceph-3-em-4-carboxylate chloride
EINECS	Contact for details

Quality Control

Every batch of Ceftazidime Ep Impurity C Chloride is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced techniques like HPLC, NMR, and Mass Spectrometry to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines.

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. Avoid exposure to excessive heat and humidity.

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
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%

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