Description

Acetaminophen Impurity 14 CAS NO 1991204-56-8 is a high-purity chemical reference standard used for the identification, qualification, and quantification of related substances in Acetaminophen (Paracetamol) active pharmaceutical ingredients (APIs) and finished drug products. This impurity standard is critical for ensuring drug safety, efficacy, and regulatory compliance by enabling accurate analytical method development and validation. It is an essential tool for quality control laboratories in the pharmaceutical industry, contract research organizations (CROs), and regulatory bodies focused on impurity profiling and stability studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material (CRM) for the identification and control of specified and unspecified impurities in Acetaminophen/Paracetamol drug substances and products according to ICH Q3A(R2) and Q3B(R2) guidelines.
• Analytical Method Development & Validation: Used as a system suitability standard and for establishing the specificity, accuracy, and detection limits of chromatographic methods, primarily HPLC and UPLC.
• Stability Indicating Methods: Employed in forced degradation studies to monitor the formation of degradation products and to demonstrate the stability-indicating power of analytical procedures.
• Pharmacopoeial Compliance: Supports testing to meet the stringent impurity limits set by major pharmacopoeias such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), and BP (British Pharmacopoeia).
• Quality Control & Batch Release: Essential for the routine quality control testing of Acetaminophen API and formulated products to ensure batch-to-batch consistency and compliance with release specifications.
• Regulatory Submissions: Provides critical data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control strategies.

Basic Information

Product Name	Acetaminophen Impurity 14
CAS No.	1991204-56-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Paracetamol Impurity 14; APAP Impurity 14; N-(4-Hydroxyphenyl)acetamide Impurity 14; 4'-Hydroxyacetanilide Related Compound 14; Acetaminophen Related Substance 14; Acetyl-p-aminophenol Impurity 14; p-Acetamidophenol Impurity 14
EINECS	Contact for details

Quality Control

Every batch of Acetaminophen Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results from HPLC, NMR, and MS 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. The material is light-sensitive and should be handled under appropriate conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to Off-white Solid
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%
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.