Description

Phenacetin Impurity 16 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 or derived from phenacetin. It is primarily required by analytical laboratories and quality control units within the pharmaceutical and life sciences industries. The material is essential for method development, validation, and the accurate quantification of impurities in active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Phenacetin Impurity 16 in drug substances and products.
• Analytical Method Development: Used in HPLC, UPLC, and GC method development and validation for impurity profiling.
• Quality Control & Assurance: Critical for routine QC testing in pharmaceutical manufacturing to monitor and control impurity levels, ensuring batch-to-batch consistency.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data for impurity identification and qualification as per ICH guidelines.
• Research & Development: Utilized in stability studies, degradation pathway elucidation, and metabolic research related to phenacetin.
• Calibration Standard: Acts as a primary standard for calibrating analytical instruments to ensure accurate and reliable results.

Basic Information

Product Name	Phenacetin Impurity 16
CAS No.	21650-66-8
Molecular Formula	C10H13NO2
Molecular Weight	179.22 g/mol
Synonyms	N-(4-Ethoxyphenyl)acetamide; 4'-Ethoxyacetanilide; p-Ethoxyacetanilide; 1-Acetamido-4-ethoxybenzene; Acetophenetidin Impurity; Phenacetin Related Compound; 4-Acetamidophenetole; N-Acetyl-p-phenetidine
EINECS	Contact for details

Quality Control

Every batch of Phenacetin Impurity 16 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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