Description

Acetaminophen Impurity B CAS NO 1693-37-4 is a high-purity reference standard used for the identification, qualification, and quantification of a specific impurity in Acetaminophen (Paracetamol) drug substances and products. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations. It is an essential material for quality control laboratories, analytical research, and pharmaceutical development teams focused on impurity profiling and method validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods in QC/QA.
• Impurity Profiling & Control: Used to establish specification limits and monitor levels of this specific impurity during Acetaminophen API (Active Pharmaceutical Ingredient) manufacturing.
• Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC analytical methods to separate and quantify impurities.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive identification and characterization data for specified impurities in drug dossiers.
• Stability Studies: Employed as an analytical marker to track impurity formation in drug products under various stability testing conditions (ICH guidelines).
• Research & Development: Used in pharmaceutical R&D to study degradation pathways and the chemical behavior of Acetaminophen.

Basic Information

Product Name	Acetaminophen Impurity B
CAS No.	1693-37-4
Molecular Formula	C8H9NO2
Molecular Weight	151.16 g/mol
Synonyms	4'-Hydroxyacetanilide; N-(4-Hydroxyphenyl)acetamide; Paracetamol Impurity B; APAP Impurity B; 4-Acetamidophenol Impurity; p-Hydroxyacetanilide; N-Acetyl-p-aminophenol Impurity; 1-(4-Hydroxyphenyl)ethanone imine (tautomer)
EINECS	Contact for details

Quality Control

Every batch of Acetaminophen Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure they meet the exacting 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 in a cool, dry place at controlled room temperature (15-25°C). Keep the container sealed to protect from moisture. For long-term storage under an inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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