Description

Cefoperazone Impurity 11 is a designated chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the purity, safety, and efficacy of the antibiotic Cefoperazone by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams involved in the production of cephalosporin antibiotics. The material is essential for method validation, stability studies, and meeting stringent regulatory compliance standards for impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Cefoperazone Impurity 11 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical component in developing, optimizing, and validating chromatographic methods for impurity detection and separation.
• Quality Control and Batch Release Testing: Employed in routine QA/QC testing to monitor and control impurity levels in Cefoperazone batches, ensuring they remain within pharmacopeial limits.
• Stability Studies and Forced Degradation: Used to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Facilitates research into the synthesis pathways, degradation mechanisms, and metabolic profiles of Cefoperazone and related compounds.

Basic Information

Product Name	Cefoperazone Impurity 11
CAS No.	68853-95-2
Molecular Formula	C25H27N9O8S2
Molecular Weight	645.67 g/mol
Synonyms	(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; 7-[D-(-)-α-(4-Ethyl-2,3-dioxo-1-piperazinylcarbonylamino)phenylacetamido]-3-(1-methyl-1H-tetrazol-5-ylthiomethyl)-3-cephem-4-carboxylic acid; Cefoperazone Related Compound; Cefoperazone EP Impurity; Cefoperazone USP Impurity
EINECS	Contact for details

Quality Control

Our Cefoperazone Impurity 11 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results. We support compliance with major pharmacopeial guidelines (USP, EP) and can supply materials suitable for GMP-regulated environments.

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 corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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