Description

Amoxicillin Dimer (Penicilloic Acid Form) is a key pharmaceutical impurity and degradation product of the widely used β-lactam antibiotic, amoxicillin. Its precise characterization is critical for ensuring drug safety, efficacy, and regulatory compliance in pharmaceutical manufacturing. This high-purity reference standard is essential for analytical laboratories, quality control departments, and research institutions involved in antibiotic development, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of amoxicillin-related impurities in drug substances and finished products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and LC-MS methods to monitor degradation and ensure product purity.
• Stability Indicating Studies: Employed in forced degradation studies to understand the stability profile of amoxicillin under various stress conditions (e.g., heat, humidity, light).
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to comply with pharmacopeial monographs (USP, EP, BP).
• Regulatory Submission & Compliance: Provides essential data for regulatory filings (e.g., FDA, EMA) regarding impurity thresholds as per ICH Q3A/B guidelines.
• Research on Degradation Pathways: Used in academic and industrial research to elucidate the chemical degradation mechanisms of β-lactam antibiotics.

Basic Information

Product Name	Amoxicillin Dimer (Penicilloic Acid Form)
CAS No.	210289-72-8
Molecular Formula	C32H38N6O10S2
Molecular Weight	730.81 g/mol
Synonyms	Amoxicillin Penicilloic Acid Dimer; (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 dimer; Amoxicillin Degradation Product; Amoxicillin Open-Ring Dimer; Amoxicillin Related Compound; β-Lactam Degradation Impurity
EINECS	Contact for details

Quality Control

Our Amoxicillin Dimer is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and loss on drying. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data to support your regulatory and research needs. The material is suitable for use as a pharmaceutical reference standard in compliance with current Good Manufacturing Practice (cGMP) principles.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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