Description

Phenacetin Impurity 3 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 containing Phenacetin or its derivatives. It is primarily required by analytical laboratories, quality control units, and research institutions within the pharmaceutical and life sciences sectors for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Phenacetin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, calibrate, and validate chromatographic methods, such as HPLC and UPLC, ensuring accurate impurity detection.
• Quality Control and Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor impurity levels and ensure product meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed in forced degradation and long-term stability studies of Phenacetin to understand impurity formation pathways and establish shelf-life.
• Regulatory Compliance and Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in academic and industrial R&D for studying the metabolism, degradation, and synthetic pathways of Phenacetin and related compounds.

Basic Information

Product Name	Phenacetin Impurity 3
CAS No.	24176-84-9
Molecular Formula	C10H13NO2
Molecular Weight	179.22 g/mol
Synonyms	4-Ethoxyacetanilide Impurity; N-(4-Ethoxyphenyl)acetamide Impurity; Acetophenetidin Impurity; 1-Acetamido-4-ethoxybenzene Impurity; p-Ethoxyacetanilide Impurity; Phenacetin Related Compound; Phenacetin EP Impurity; Phenacetin USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Phenacetin Impurity 3 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 industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for parameters such as assay, related substances, and residual solvents.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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