Description

Amoxicillin Ep Impurity J is a specified impurity used in the quality control and analytical profiling of the antibiotic amoxicillin. This high-purity reference standard is critical for pharmaceutical manufacturers and testing laboratories to ensure product safety and compliance with stringent pharmacopeial monographs. It is essential for method development, validation, and routine analysis in the production of amoxicillin API and finished dosage forms.

Application

• Primary use as a certified reference standard for analytical testing.
• Identification and quantification of impurities in Amoxicillin API (Active Pharmaceutical Ingredient) according to EP, USP, and other pharmacopeias.
• Method development and validation for HPLC and UPLC impurity profiling methods.
• Quality control and batch release testing in pharmaceutical manufacturing.
• Stability studies to monitor impurity formation in amoxicillin-based drug products.
• Calibration of analytical instruments for precise impurity measurement.
• Research and development of improved synthetic routes and purification processes for amoxicillin.

Basic Information

Product Name	Amoxicillin Ep Impurity J
CAS No.	73590-06-4
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 J (EP); Amoxicillin Related Compound J; Amoxicillin EP Impurity J; 6-[D(-)-α-Amino-p-hydroxybenzamido]penicillanic acid impurity; Amoxicillin impurity standard
EINECS	Contact for details

Quality Control

Every batch of Amoxicillin Ep Impurity J is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and spectroscopic identification, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and related substances.

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 in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w

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