Description

Phenacetin Impurity 18 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 related compounds. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical testing laboratories for method development, validation, and quality control testing.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for identifying and quantifying this specific impurity in Phenacetin Active Pharmaceutical Ingredient (API) and finished drug products.

• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods like HPLC and UPLC for impurity detection.

• Quality Control and Batch Release Testing: Essential for routine QC testing of Phenacetin to ensure batches meet stringent pharmacopeial (e.g., USP, EP) or internal purity specifications.

• Stability Studies and Degradation Pathway Analysis: Employed to monitor the formation of this impurity during forced degradation and long-term stability studies of pharmaceutical formulations.

• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.

• **| | |
  | --- | --- |
  | Product Name | Phenacetin Impurity 18 |
  | CAS No. | 53547-17-4 |
  | Molecular Formula | C10H13NO2 |
  | Molecular Weight | 179.22 g/mol |
  | Synonyms | N-(4-Ethoxyphenyl)acetamide Impurity 18; 4'-Ethoxyacetanilide Related Compound; Acetophenetidin Impurity; 1-Acetamido-4-ethoxybenzene Impurity; Phenacetin EP Impurity; Phenacetin USP Related Compound; N-Acetyl-p-phenetidide Impurity |
  | EINECS | Contact for details |

  Quality Control

  Every batch of Phenacetin Impurity 18 is manufactured and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) that detail purity, identity, and impurity profiles, ensuring traceability and compliance with relevant guidelines. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

  Storage

  Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light).

  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)	Individual impurity: ≤ 1.0% 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.**