Description

AMOXICILLIN TRIHYDRATE IMP. D (EP) AS SODIUM SALT:(4S)-2-[[[(2R)-2-AMINO-2-(4-HYDROXYPHENYL)ACETYL]AMINO]-CARBOXYMETHYL]-5,5-DIMETHYLTHIAZOLIDINE-4-CARBOXYLIC ACID SODIUM SALT (PENICILLOICACIDS OF AMO is a high-purity reference standard and impurity used in the pharmaceutical development and quality control of amoxicillin-based antibiotics. This compound is critical for ensuring the safety and efficacy of final drug products by allowing for the accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for compliance with stringent pharmacopeial standards, including the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of test methods in accordance with EP, USP, and ICH guidelines.
• Analytical Method Development: Used in research and quality control laboratories to develop and optimize HPLC, UPLC, and LC-MS methods for the separation and detection of amoxicillin impurities.
• Drug Substance and Product Testing: Essential for the identification, assay, and related substance testing of amoxicillin trihydrate active pharmaceutical ingredient (API) and finished dosage forms.
• Stability Studies: Employed to monitor the formation of degradation products in amoxicillin formulations under various stress conditions, supporting shelf-life determination.
• Regulatory Compliance and Filing: Provides necessary data for regulatory submissions (e.g., CMC sections) to agencies like the FDA and EMA, demonstrating thorough impurity profiling.
• Quality Assurance/Quality Control (QA/QC): A critical tool for in-process testing and batch release to ensure drug purity and patient safety.

Basic Information

Product Name	AMOXICILLIN TRIHYDRATE IMP. D (EP) AS SODIUM SALT:(4S)-2-[[[(2R)-2-AMINO-2-(4-HYDROXYPHENYL)ACETYL]AMINO]-CARBOXYMETHYL]-5,5-DIMETHYLTHIAZOLIDINE-4-CARBOXYLIC ACID SODIUM SALT (PENICILLOICACIDS OF AMO
CAS No.	1642629-94-4
Molecular Formula	C16H19N3O6S • Na
Molecular Weight	404.39 g/mol
Synonyms	Amoxicillin Penicilloic Acid Sodium Salt; (4S)-2-[[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-carboxymethyl]-5,5-dimethylthiazolidine-4-carboxylic Acid Sodium Salt; Amoxicillin Impurity D Sodium Salt (EP); Amoxicillin Related Compound D (Sodium Salt); Amoxicillin Degradant D Sodium Salt; Amoxicillin EP Impurity D (Sodium Salt); Penicilloic Acids of Amoxicillin Sodium Salt
EINECS	Contact for details

Quality Control

This high-purity pharmaceutical impurity is manufactured and controlled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the stringent specifications outlined in the European Pharmacopoeia (EP) monograph for Amoxicillin Trihydrate. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting the results against predefined acceptance criteria. Our quality commitment aligns with cGMP principles to support our clients' regulatory needs.

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 product is hygroscopic (moisture-sensitive) and must be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.