Description

Cefazedone Impurity 12 is a designated chemical reference standard used in the analytical profiling and quality control of the antibiotic Cefazedone. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and as a critical component in impurity identification studies for cephalosporin antibiotics.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantification and qualification of Cefazedone in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Essential for developing and validating robust analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS, in quality control laboratories.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to monitor the formation of this specific impurity during forced degradation and long-term stability testing of Cefazedone.
• Research and Development: Employed in synthetic chemistry R&D to understand degradation pathways and to optimize manufacturing processes to minimize impurity formation.
• Quality Assurance/Quality Control (QA/QC): A key tool for in-process testing and release testing to ensure Cefazedone batches meet stringent purity specifications.

Basic Information

Item	Details
Product Name	Cefazedone Impurity 12
CAS No.	788106-07-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefazedone Related Compound 12; Cefazedone EP Impurity 12; Cefazedone USP Impurity 12; Cefazedone Degradation Product; (6R,7R)-7-[[(2R)-2-Amino-2-phenylacetyl]amino]-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid impurity; Cefazedone Process Impurity; Cefazedone Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Cefazedone Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic and spectroscopic techniques to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 must be kept in a desiccated environment to maintain stability and purity.

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%
Water Content	≤ 5.0%
Residual Solvents	Complies with ICH guidelines

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