Description

Acetaminophen Impurity 11 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 standard for the identification and quantification of specific impurities in Acetaminophen/Paracetamol Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods to monitor impurity levels 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 thresholds.
• 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 providing impurity characterization data in regulatory filings for drug approval with agencies like the FDA, EMA, and PMDA.
• Research & Development: Utilized in pharmaceutical R&D to study the degradation pathways and chemical stability of acetaminophen.

Basic Information

Product Name	Acetaminophen Impurity 11
CAS No.	801215-24-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Paracetamol Impurity 11; 4'-Hydroxyacetanilide Impurity 11; N-(4-Hydroxyphenyl)acetamide Impurity 11; APAP Impurity 11; Acetaminophen Related Compound 11; 1-(4-Hydroxyphenyl)-2-(methylamino)ethan-1-one; Potential degradation product of Acetaminophen
EINECS	Contact for details

Quality Control

Our Acetaminophen Impurity 11 is manufactured and handled under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring traceability and compliance with current industry standards for reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

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

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