Description

Amoxicillin Impurity 11 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the widely used antibiotic, amoxicillin. It is an essential material for analytical chemists and quality assurance professionals engaged in method validation, impurity profiling, and stability studies. Pharmaceutical companies and contract research organizations (CROs) rely on such well-characterized impurities to meet stringent pharmacopeial standards for drug substances and finished products.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Amoxicillin API and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for impurity profiling.
• Essential for conducting stability studies and forced degradation studies to monitor impurity formation over time.
• Used in pharmacopeial testing to comply with USP, EP, ICH, and other regulatory guidelines for impurity limits.
• Serves as a key material in quality control (QC) laboratories for routine batch release testing of amoxicillin.
• Valuable for research and development to understand the degradation pathways and chemistry of amoxicillin.

Basic Information

Product Name	Amoxicillin Impurity 11
CAS No.	2088961-39-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Amoxicillin Related Compound 11; Amoxicillin EP Impurity J; Amoxicillin USP Related Substance 11; (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 Degradation Product; Amoxicillin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Amoxicillin Impurity 11 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure identity, purity, and compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for all critical parameters. We support compliance with ICH Q3A/B, USP, and EP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms
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.