Description

Amoxicillin Related Compound D (50 mg) ((4S)-2-{(R)-2-amino-2-(4-hydroxyphenyl)acetamidomethyl}-5,5-dimethylthiazolidine-4-carboxylic acid, monosodium salt) is a high-purity chemical reference standard critical for analytical and quality control processes in the pharmaceutical industry. This compound serves as a specified impurity standard for the widely used β-lactam antibiotic, amoxicillin, enabling precise identification and quantification during drug development and manufacturing. It is an essential tool for researchers, analytical laboratories, and quality assurance departments focused on ensuring the safety, efficacy, and regulatory compliance of amoxicillin-based pharmaceuticals.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material (CRM) for the identification and quantification of Related Compound D 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, and other chromatographic methods for amoxicillin analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels and ensure compliance with pharmacopoeial specifications (e.g., USP, EP, BP).
• Stability Studies: Used to track the formation of degradation products in amoxicillin formulations under various stress conditions (e.g., heat, humidity, light) as part of stability-indicating assays.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies for amoxicillin.
• Research and Development: Facilitates studies on the degradation pathways, synthesis impurities, and metabolic byproducts of amoxicillin in pharmaceutical R&D.

Basic Information

Item	Details
Product Name	Amoxicillin Related Compound D (50 mg) ((4S)-2-{(R)-2-amino-2-(4-hydroxyphenyl)acetamidomethyl}-5,5-dimethylthiazolidine-4-carboxylic acid, monosodium salt)
CAS No.	68728-47-2
Molecular Formula	C19H23N3O7S.Na
Molecular Weight	460.46 g/mol
Synonyms	Amoxicillin Impurity D; Amoxicillin EP Impurity D; Amoxicillin Related Substance D; (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 D; Sodium (4S)-2-[(2R)-2-amino-2-(4-hydroxyphenyl)acetamido]-5,5-dimethyl-1,3-thiazolidine-4-carboxylate; Amoxicillin Sodium Salt Impurity D
EINECS	Contact for details

Quality Control

Every batch of Amoxicillin Related Compound D is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and potency, aligning with the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each unit, detailing results from advanced analytical techniques such as HPLC, NMR, and mass spectrometry. Our quality commitment supports compliance with cGMP and relevant pharmacopoeial guidelines for impurity standards.

Storage

Preserve in the original, tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This compound is hygroscopic (moisture-sensitive); ensure the container is kept sealed in a low-humidity environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%

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