Description

Amoxicillin Impurity J is a high-purity chemical reference standard used for the identification and quantification of related substances in amoxicillin drug substances and finished pharmaceutical products. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of amoxicillin-based antibiotics through rigorous analytical control. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Amoxicillin Impurity J in HPLC, UPLC, and LC-MS methods.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating assay methods for amoxicillin API and finished dosage forms according to ICH guidelines.
• Quality Control & Batch Release Testing: Used in QC laboratories to monitor impurity profiles and ensure drug substance and product specifications meet pharmacopeial standards (USP, EP, BP).
• Stability Studies & Forced Degradation: Employed to identify and track degradation products formed under various stress conditions (heat, light, humidity, acid/base).
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing impurity characterization data and specifications.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of amoxicillin to improve formulation stability.

Basic Information

Product Name	Amoxicillin Impurity J
CAS No.	2088960-43-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2S,5R,6R)-6-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Impurity J; Amoxicillin Related Compound J; Amoxicillin EP Impurity J; Amoxicillin USP Impurity J; Amoxycillin Impurity J; 4-Hydroxy Amoxicillin Degradant; Amoxicillin Hydroxy Phenyl Impurity
EINECS	Contact for details

Quality Control

Every batch of Amoxicillin Impurity J is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and protected from light exposure to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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