Description

Amoxicillin Impurity 28 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 primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and routine quality control testing. The availability of well-characterized impurities like this is essential for maintaining the stringent purity standards demanded in modern pharmaceutical production.

Application

This high-purity impurity standard serves several key functions in the pharmaceutical and analytical chemistry sectors:

• Pharmaceutical Quality Control (QC): Used as a certified reference material for the identification and quantification of impurities in amoxicillin active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or other chromatographic methods to monitor amoxicillin purity and stability.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity samples for stability studies, specification setting, and impurity profiling as per ICH guidelines.
• Stability Studies & Forced Degradation: Employed in studies to understand the degradation pathways of amoxicillin and to identify potential degradation products.
• Research & Development: Used in academic and industrial R&D settings to study the chemical behavior, synthesis pathways, and metabolic fate of amoxicillin-related compounds.

Basic Information

Product Name	Amoxicillin Impurity 28
CAS No.	37727-80-3
Molecular Formula	C16H19N3O5S
Molecular Weight	365.41 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; Amoxicillin Impurity J; Amoxicillin Related Compound J; Amoxicillin EP Impurity J; Amoxicillin USP Related Compound J; 4-Hydroxy Amoxicillin; Amoxicillin Degradant
EINECS	Contact for details

Quality Control

Every batch of Amoxicillin Impurity 28 is produced and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and loss on drying. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality standards align with the requirements for pharmaceutical reference standards, supporting compliance with pharmacopeial guidelines (USP, EP).

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

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)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.