Description

Amoxicillin Trimer Impurity is a critical process-related impurity formed during the synthesis of the widely used β-lactam antibiotic, amoxicillin. This compound is essential for pharmaceutical research and development, specifically for method validation, stability studies, and ensuring the purity and safety of the final drug product. It is primarily utilized by analytical laboratories, quality control units, and R&D departments within the global pharmaceutical and fine chemical industries to meet stringent regulatory requirements for impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the trimer impurity in amoxicillin drug substance and finished products.
• Analytical Method Development and Validation (HPLC/LC-MS): Critical for developing, optimizing, and validating chromatographic methods to accurately separate and measure this specific degradation product.
• Stability and Forced Degradation Studies: Employed to understand the degradation pathways of amoxicillin and to establish appropriate shelf-life and storage conditions for the API.
• Quality Control and Batch Release Testing: Serves as a system suitability standard in routine QC testing to ensure the impurity profile of amoxicillin batches complies with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Regulatory Submission and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research into Degradation Mechanisms: Aids academic and industrial researchers in studying the chemical behavior and formation kinetics of β-lactam polymer impurities.

Basic Information

Item	Detail
Product Name	Amoxicillin Trimer Impurity
CAS No.	2088961-40-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Amoxicillin Trimer; Amoxicillin Oligomer; Amoxicillin Polymer Impurity; β-Lactam Polymer Impurity; Amoxicillin Degradation Product; (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 Trimer; Amox Trimer
EINECS	Contact for details

Quality Control

Our Amoxicillin Trimer Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure identity, potency, and consistency. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, supporting compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines for impurities in new drug substances and products.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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