Description

Acetaminophen Impurity 12 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 acetaminophen (paracetamol) pharmaceutical products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in acetaminophen Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurities in compliance with ICH Q3A/B guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure batch-to-batch consistency and that impurity levels remain within specified safety limits.
• Stability Studies: Used to track the formation of degradation products in acetaminophen formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Essential for preparing documentation for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research & Development: Supports R&D efforts in understanding the degradation pathways and metabolism of acetaminophen.

Basic Information

Item	Details
Product Name	Acetaminophen Impurity 12
CAS No.	1374027-64-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Paracetamol Impurity 12; APAP Impurity 12; N-(4-Hydroxyphenyl)acetamide Impurity 12; 4'-Hydroxyacetanilide Related Compound 12; Acetaminophen Related Substance 12; p-Acetamidophenol Impurity 12
EINECS	Contact for details

Quality Control

Every batch of Acetaminophen Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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