Description

Rac-Amoxicillin Ep Impurity H is a critical reference standard used in the pharmaceutical quality control process. This compound is essential for the accurate identification, quantification, and monitoring of a specified impurity in Amoxicillin drug substances and finished products, ensuring compliance with stringent pharmacopeial guidelines. It is primarily required by analytical laboratories, quality assurance departments, and manufacturers within the global pharmaceutical and biotechnology sectors to validate analytical methods and guarantee product safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development and validation in HPLC and related chromatographic analyses.
• Quality Control & Assurance: Used for the precise quantification of Rac-Amoxicillin Ep Impurity H in Amoxicillin active pharmaceutical ingredients (APIs) to ensure they meet EP, USP, or other pharmacopeia specifications.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Stability Studies: Employed to monitor impurity levels in Amoxicillin formulations over time under various storage conditions.
• Research & Development: Utilized in pharmaceutical R&D to study the degradation pathways and formation mechanisms of Amoxicillin impurities.
• Contract Research Organizations (CROs): Essential analytical tool for CROs providing testing and compliance services to drug manufacturers.

Basic Information

Product Name	Rac-Amoxicillin Ep Impurity H
CAS No.	106644-43-3
Molecular Formula	C16H19N3O5S
Molecular Weight	365.41 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 H (EP); Amoxicillin Related Compound H; (5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid; Rac-Amoxicillin EP Impurity H; Amoxicillin Diastereomer Impurity
EINECS	Contact for details

Quality Control

Every batch of Rac-Amoxicillin Ep Impurity H is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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. Handle the container with care to minimize exposure to atmospheric humidity during use.

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%
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.