Description

Phenacetin Impurity 20 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, specifically those related to phenacetin. It is primarily required by analytical laboratories, quality control units, and research institutions engaged in pharmaceutical development and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of impurities in Phenacetin Active Pharmaceutical Ingredient (API) and related formulations.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate chromatographic methods like HPLC and UPLC.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor and control impurity levels against ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data for drug master files.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies of drug substances and products.
• Research & Development: Used in academic and industrial R&D for studying the metabolism, degradation pathways, and synthesis of phenacetin and related compounds.

Basic Information

Item	Details
Product Name	Phenacetin Impurity 20
CAS No.	51437-64-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Phenacetin Related Compound 20; Acetophenetidin Impurity 20; 4'-Ethoxyacetanilide Impurity; N-(4-Ethoxyphenyl)acetamide Impurity 20; Phenacetin EP Impurity; Phenacetin USP Impurity; A specific isomer or derivative of Phenacetin (Contact for precise IUPAC name)
EINECS	Contact for details

Quality Control

Every batch of Phenacetin Impurity 20 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing purity, assay results, and chromatographic data is provided with each shipment and is available upon request.

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); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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