Description

Ceftezole Impurity 3 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Ceftezole. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, impurity profiling, and quality control testing of cephalosporin antibiotics.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Ceftezole bulk drug and finished dosage forms.
• Analytical Method Development and Validation: Essential for developing, calibrating, and validating chromatographic methods (e.g., HPLC, UPLC) to ensure accurate impurity detection.
• Quality Control (QC) and Quality Assurance (QA): Serves as a benchmark in routine QC testing to monitor batch-to-batch consistency and ensure compliance with pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to track the formation and level of this impurity during forced degradation and long-term stability studies of Ceftezole.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and control strategies.
• Research and Development: Used in R&D to study the degradation pathways, synthesis by-products, and metabolic profiles related to Ceftezole.

Basic Information

Product Name	Ceftezole Impurity 3 Hcl
CAS No.	59314-23-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ceftezole Related Compound 3; Ceftezole EP Impurity C; Ceftezole USP Impurity; (6R,7R)-3-[[(5-Methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[(2-(1H-tetrazol-1-yl)acetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid hydrochloride; Ceftezole Impurity 3 Hydrochloride; Ceftezole Specified Impurity
EINECS	Contact for details

Quality Control

Our Ceftezole Impurity 3 Hcl is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is rigorously tested using validated analytical methods, including HPLC for purity and identity confirmation via spectroscopic techniques. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay, and impurity profiles. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial monographs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Report individual and total impurities

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