Description

Phenacetin Impurity 17 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 required by analytical laboratories and quality control units within the pharmaceutical and life sciences industries for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Phenacetin Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, calibrate, and validate chromatographic methods, such as HPLC and UPLC, ensuring accurate impurity detection.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance & Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA, ICH) by providing definitive impurity characterization data.
• Stability Studies: Employed in forced degradation and long-term stability testing of drug substances to track the formation of related substances over time.
• Research & Development: Used in academic and industrial R&D settings to study the metabolism, degradation pathways, and synthesis of Phenacetin and its analogs.

Basic Information

Product Name	Phenacetin Impurity 17
CAS No.	30926-06-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1-(4-Ethoxyphenyl)-2-methyl-4-nitroimidazole; 4-Nitro-1-(p-ethoxyphenyl)-2-methylimidazole; Phenacetin Nitroimidazole Impurity; Phenacetin Related Compound; 4-Nitro-2-methyl-1-(4-ethoxyphenyl)-1H-imidazole
EINECS	Contact for details

Quality Control

Every batch of Phenacetin Impurity 17 is manufactured and controlled under a strict quality management system. Our products undergo rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and other relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (typically 15-25°C). The material should be kept in a desiccated environment to maintain stability. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	Off-white to light yellow powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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