Description

Amoxicillin Impurity 27 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the widely used antibiotic amoxicillin. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in amoxicillin active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for amoxicillin analysis.
• Stability Studies and Forced Degradation: Employed to monitor the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control as per ICH Q3A/B guidelines.
• Quality Control and Batch Release Testing: Used in routine QC testing to ensure amoxicillin batches meet stringent pharmacopeial (USP, EP, JP) specifications for impurity limits.
• Research on Degradation Pathways: Aids in academic and industrial research to understand the chemical degradation mechanisms of amoxicillin.

Basic Information

Product Name	Amoxicillin Impurity 27
CAS No.	1978372-79-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Amoxicillin Related Compound 27; Amoxicillin EP Impurity J; Amoxicillin USP Impurity; (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 Degradant; Amoxicillin Process Impurity; Amox EP Imp J
EINECS	Contact for details

Quality Control

Our Amoxicillin Impurity 27 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification via spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container tightly sealed in a dry and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
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.