Description

Potassium Clavulanate Ep Impurity Genantiomer is a high-purity reference standard specifically used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the safety and efficacy of clavulanate-containing antibiotic formulations by enabling the accurate identification and quantification of its enantiomeric impurity. It is an essential material for analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and fine chemical sectors focused on regulatory compliance and method validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods in compliance with pharmacopeial guidelines (e.g., USP, EP).
• Impurity Profiling & Control: Critical for the identification, characterization, and quantification of the specific enantiomeric impurity during the stability testing and release of Potassium Clavulanate API and finished drug products.
• Analytical Method Development: Serves as a key component in developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity separation and analysis.
• Quality Assurance & Control (QA/QC): Used in-house by API manufacturers and finished dosage form producers to monitor batch-to-batch consistency and ensure impurity levels remain within specified limits.
• Regulatory Submissions: Provides essential data and impurity samples for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive understanding and control of the drug substance.
• Research & Development: Supports studies on the stereochemistry, degradation pathways, and pharmacokinetics of clavulanate derivatives.

Basic Information

Product Name	Potassium Clavulanate Ep Impurity Genantiomer
CAS No.	887256-29-3
Molecular Formula	C8H8KNO5
Molecular Weight	237.25 g/mol
Synonyms	(2R,5R)-3-(2-Hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic acid potassium salt; Potassium (2R,5R)-clavulanate; Clavulanic acid potassium salt impurity enantiomer; Genantiomer of Potassium Clavulanate EP Impurity; (5R)-Clavulanate Potassium; Clavulanate Potassium Enantiomeric Impurity
EINECS	Contact for details

Quality Control

Every batch of Potassium Clavulanate Ep Impurity Genantiomer is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure it meets the high-purity standards required for use as a reference standard. Comprehensive analytical characterization, including chiral purity by HPLC, is performed. A detailed Certificate of Analysis (COA) providing batch-specific results is supplied with each shipment.

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 product is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC, Area %)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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