Description

Cefoperazone Impurity 8 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 antibiotic Cefoperazone by serving as a known benchmark in impurity profiling. It is an essential material for pharmaceutical quality control laboratories, analytical research and development teams, and regulatory affairs departments focused on method validation and stability studies.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference standard in HPLC and LC-MS methods to identify, quantify, and monitor this specific impurity in Cefoperazone Sodium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical component for developing, optimizing, and validating stability-indicating analytical methods according to ICH Q2(R1) guidelines.
• Quality Control and Batch Release Testing: Employed in routine QC testing of Cefoperazone API to ensure impurity levels remain within specified limits as per pharmacopeial standards (e.g., USP, EP).
• Stability Studies and Forced Degradation Studies: Acts as a marker to track the formation of this impurity under various stress conditions (heat, light, humidity, acid/base), supporting drug shelf-life determination.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., ANDA, NDA, CMC documentation) to demonstrate thorough impurity characterization and control strategies to agencies like the FDA and EMA.
• Research on Degradation Pathways: Used in academic and industrial research to study the chemical degradation mechanisms of Cefoperazone, aiding in the development of more stable formulations.
• Calibration and System Suitability Testing: Functions as a precise calibrant to ensure the accuracy and precision of chromatographic systems used in pharmaceutical analysis.

Basic Information

Product Name	Cefoperazone Impurity 8
CAS No.	1204325-21-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefoperazone Related Compound 8; Cefoperazone EP Impurity 8; Cefoperazone USP Impurity 8; (6R,7R)-7-[[(2R)-2-[[(4-Ethyl-2,3-dioxopiperazin-1-yl)carbonyl]amino]-2-phenylacetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)sulfanyl]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid Impurity; Cefoperazone Degradation Product; Cefoperazone Process Impurity
EINECS	Contact for details

Quality Control

Our Cefoperazone Impurity 8 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, spectroscopic identification (NMR, MS, IR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. For long-term storage, consider desiccant conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.