Description

Cefoperazone Impurity 12 CAS NO 348088-68-6 is a characterized impurity and reference standard used in the analytical profiling of the antibiotic Cefoperazone. This compound is critical for pharmaceutical research and development, enabling precise identification, quantification, and control of impurities to ensure drug safety and efficacy. It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and biotechnology industries for method validation, stability studies, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantitative and qualitative analysis of Cefoperazone and its related substances.
• Method Development and Validation: Essential for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in QC laboratories.
• Stability Indicating Studies: Used to monitor the formation of degradation products in Cefoperazone drug substance and finished products under various stress conditions.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for Drug Master Files (DMFs) and marketing authorization applications.
• Quality Control Testing: Employed in the routine batch release testing of Cefoperazone to ensure impurity levels are within specified pharmacopeial limits (e.g., USP, EP).
• Research and Development: Aids in the synthesis pathway optimization and impurity profiling during the development of Cefoperazone and its generic versions.

Basic Information

Product Name	Cefoperazone Impurity 12
CAS No.	348088-68-6
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; Cefoperazone Related Compound; Cefoperazone EP Impurity; Cefoperazone USP Impurity; Cefoperazone Degradation Product; Cefobid Impurity
EINECS	Contact for details

Quality Control

Our Cefoperazone Impurity 12 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (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 and traceability. Our quality commitment aligns with the needs of cGMP-compliant environments.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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