Description

Amoxicillin Ep Impurity C 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.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Amoxicillin drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control & Assurance (QC/QA): Serves as a critical benchmark in routine quality control testing to monitor impurity levels against pharmacopeial limits (e.g., EP, USP).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions to determine drug shelf-life.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization and control strategies.
• Research & Development: Used in pharmaceutical R&D to study degradation pathways and the chemical behavior of Amoxicillin.

Basic Information

Product Name	Amoxicillin Ep Impurity C
CAS No.	2088961-37-7
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; EP Impurity C of Amoxicillin; (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
EINECS	Contact for details

Quality Control

Every batch of Amoxicillin Ep Impurity C is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with relevant pharmacopeial standards (EP, USP) and in-house specifications. A comprehensive Certificate of Analysis (COA), detailing batch-specific results from advanced analytical techniques (HPLC, NMR, MS), is provided with each shipment to guarantee traceability and reliability for your critical applications.

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 under dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccants or an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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