Description

Amoxicillin Impurity 3 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the widely used antibiotic amoxicillin by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical manufacturers, quality control laboratories, and regulatory bodies focused on compliance with pharmacopeial standards such as USP, EP, and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in amoxicillin active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: A critical component in developing and validating High-Performance Liquid Chromatography (HPLC), UPLC, and other chromatographic methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor and control impurity levels, ensuring batch-to-batch consistency and compliance with regulatory specifications.
• Stability Studies: Used to track the formation of degradation products in amoxicillin formulations under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity characterization.
• Research & Development: Supports research into the degradation pathways, metabolism, and pharmacokinetics of amoxicillin.

Basic Information

Product Name	Amoxicillin Impurity 3
CAS No.	297175-66-7
Molecular Formula	C16H19N3O5S
Molecular Weight	365.40 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 C; Amoxicillin Related Compound C; 4-Hydroxy Amoxicillin; Amoxicillin EP Impurity C; Amoxicillin USP Related Compound C
EINECS	Contact for details

Quality Control

Every batch of Amoxicillin Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and impurity testing using validated analytical methods, including HPLC, NMR, and MS, to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
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.