Description

Amoxicillin Ep Impurity L is a high-purity chemical reference standard, specifically identified as an impurity of the widely used β-lactam antibiotic Amoxicillin. This compound is critical for pharmaceutical quality control and analytical method development, ensuring the safety and efficacy of the final drug product. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical manufacturers involved in regulatory compliance, stability studies, and impurity profiling for Amoxicillin-based formulations.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of related substances in Amoxicillin drug substances and finished products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of degradation products in Amoxicillin formulations.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization as per ICH guidelines.
• Quality Control (QC) Testing: Acts as a system suitability standard and a calibrant in routine QC testing within pharmaceutical manufacturing environments.
• Research and Development: Used in R&D to study the degradation pathways and chemical behavior of Amoxicillin under various conditions.

Basic Information

Product Name	Amoxicillin Ep Impurity L
CAS No.	1789703-32-7
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; Amoxicillin Related Compound L; Amoxicillin Impurity L (EP); Amoxicillin European Pharmacopoeia Impurity L; Amoxicillin EP Imp L
EINECS	Contact for details

Quality Control

Every batch of Amoxicillin Ep Impurity L is manufactured and controlled under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmacopoeial standards (e.g., EP, USP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing the results of all quality tests, including HPLC purity, is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use and inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specification
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.