Description

Amoxicillin Trimer CAS NO 174391-69-6 is a high-purity dimeric impurity of the widely used β-lactam antibiotic, amoxicillin. This compound is of critical importance in the pharmaceutical industry for analytical and regulatory purposes, specifically in the development and quality control of amoxicillin-based drug products. It serves as a certified reference material for precise impurity profiling, method validation, and stability studies. Pharmaceutical manufacturers, analytical laboratories, and research institutions require this standard to ensure drug safety, efficacy, and compliance with stringent pharmacopeial guidelines from the USP, EP, and ICH.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of the trimer in amoxicillin active pharmaceutical ingredients (APIs) and finished drug products.
• HPLC Method Development & Validation: Critical for developing, optimizing, and validating chromatographic methods to separate and analyze amoxicillin and its related substances.
• Stability Indicating Method: Used in forced degradation and long-term stability studies to monitor the formation of this specific degradation product under various stress conditions.
• Quality Control & Batch Release: Essential for in-house QC laboratories to test incoming API and finished products against impurity limits specified in pharmacopeias.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity profiles for drug master files (DMFs) and marketing authorization applications.
• Research & Development: Used in R&D to study the degradation pathways of amoxicillin and to develop more stable formulations.

Basic Information

Product Name	Amoxicillin Trimer
CAS No.	174391-69-6
Molecular Formula	C48H54N12O18S3
Molecular Weight	1183.22 g/mol
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 Trimer; Amoxicillin Dimer Impurity; Amoxicillin Related Compound C (Trimer); Amoxicillin Oligomer; β-Lactam Dimer Impurity; Antibiotic Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of our Amoxicillin Trimer is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and suitability for use as an analytical reference standard. Testing typically includes HPLC for assay and related substances, IR for identification, and loss on drying. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all test results against established specifications. Our quality commitment aligns with the standards expected for pharmaceutical impurity standards.

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 must be kept in a desiccated environment to maintain stability and purity. Avoid exposure to excessive heat and humidity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Loss on Drying	≤ 5.0%

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