Description

Ceftazidime Ep Impurity B CAS NO 97148-38-4 is a specified impurity and reference standard used in the analytical profiling of the antibiotic Ceftazidime. This compound is critical for ensuring the purity, safety, and efficacy of Ceftazidime active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for method development, validation, and routine batch analysis.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ceftazidime API and formulations.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or other chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Ceftazidime batches comply with pharmacopoeial specifications (e.g., EP, USP, BP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Research & Development: Utilized in R&D to understand the degradation pathways and chemical behavior of Ceftazidime.

Basic Information

Item	Detail
Product Name	Ceftazidime Ep Impurity B
CAS No.	97148-38-4
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 Impurity B (EP); Ceftazidime Related Compound B; 1-[[(6R,7R)-7-[[(2Z)-2-(2-Aminothiazol-4-yl)-2-(2-carboxypropan-2-yloxy)iminoacetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]pyridin-1-ium; Ceftazidime Pyridinium Impurity
EINECS	Contact for details

Quality Control

Our Ceftazidime Ep Impurity B is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards.

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. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%

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