Description

Diphenylethanone Impurity 4 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 pharmaceutical products and advanced materials. It is primarily required by analytical laboratories, quality control departments, and R&D teams in the pharmaceutical, agrochemical, and fine chemical industries for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material (CRM) for the identification and quantification of related substances in Diphenylethanone (Benzil) and its derivative APIs.
• Analytical Method Development & Validation: Used as a known impurity standard to develop, calibrate, and validate HPLC, GC-MS, and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and release testing of bulk active pharmaceutical ingredients (APIs) to meet ICH Q3A/B guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs).
• Chemical Research & Synthesis: Used as a building block or intermediate in organic synthesis and process chemistry research for novel compound development.
• Stability Studies: Employed as a marker to monitor degradation pathways and establish shelf-life specifications for pharmaceutical formulations.

Basic Information

Product Name	Diphenylethanone Impurity 4
CAS No.	113454-71-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Benzil Related Compound; Benzil Impurity 4; 1,2-Diphenylethane-1,2-dione Impurity; Diphenylethanone Related Substance 4; 1,2-Diphenylethanedione Impurity; (Oxodiphenyl)ethane Impurity; α-Diketone Impurity; Diphenylglyoxal Impurity
EINECS	Contact for details

Quality Control

Every batch of Diphenylethanone Impurity 4 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, GC-MS, and NMR, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We adhere to relevant industry standards for reference materials to support your compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, well-ventilated area at controlled room temperature (15-25°C). Keep the container tightly sealed to prevent contamination and moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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