Description

Clavulanate Potassium Impurity 25 is a specified impurity and reference standard used in the quality control of clavulanate potassium, a key β-lactamase inhibitor in combination antibiotics. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized in research, development, and quality assurance processes within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Impurity 25 in clavulanate potassium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating precise HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to monitor impurity levels against ICH guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Process Chemistry Research: Used to study and optimize synthesis pathways to minimize the formation of this impurity during API manufacturing.

Basic Information

Item	Details
Product Name	Clavulanate Potassium Impurity 25
CAS No.	64519-79-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(2R,3Z,5R)-3-(2-Hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Potassium Salt; Clavulanic Acid Related Compound; Clavulanate Potassium EP Impurity; Clavulanic Acid Impurity; Potassium (2R,3Z,5R)-3-(2-Hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate
EINECS	Contact for details

Quality Control

Our Clavulanate Potassium Impurity 25 is manufactured and handled under strict quality management systems. Each batch is characterized and tested using advanced analytical techniques such as HPLC, NMR, and MS to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality standards align with ICH Q3A/B 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 (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment. For long-term storage, consider conditions under an inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Water Content	≤ 5.0%
Residual Solvents	Complies with ICH limits

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