Description

Acetaminophen Impurity B is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of acetaminophen (paracetamol) in pharmaceutical manufacturing. It is primarily required by analytical laboratories, quality control departments, and research institutions involved in pharmaceutical development and regulatory compliance. The material is essential for method validation, impurity profiling, and stability studies of drug substances and products.

Application

• Pharmaceutical Reference Standard for HPLC and GC analysis.
• Impurity profiling and identification in Acetaminophen (Paracetamol) API.
• Method development and validation for quality control laboratories.
• Stability indicating studies and forced degradation studies.
• Calibration of analytical instruments in regulatory testing.
• Research and development of impurity synthesis pathways.
• Preparation of certified reference materials (CRMs).
• Teaching and academic research in pharmaceutical chemistry.

Basic Information

Product Name	Acetaminophen Impurity B
CAS No.	98966-17-7
Molecular Formula	C8H9NO2
Molecular Weight	151.16 g/mol
Synonyms	1-(4-Hydroxyphenyl)ethanone oxime; Paracetamol Impurity B; APAP Impurity B; 4'-Hydroxyacetophenone oxime; N-(4-Hydroxyphenyl)acetimidic acid; Acetaminophen Related Compound B; 4-Acetamidophenol Impurity B
EINECS	Contact for details

Quality Control

Our Acetaminophen Impurity B is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR). We provide full traceability and Certificates of Analysis (COA) are supplied with every shipment, detailing batch-specific results. The material is suitable for use as a pharmaceutical reference standard in compliance with ICH guidelines.

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); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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