Description

Clavulanic Acid Dimer Impurity CAS NO 1260617-10-4 is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the purity and safety of clavulanate potassium and amoxicillin-clavulanate combination drug products by serving as a key marker for degradation and process-related impurities. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and QC/QA laboratories, enabling accurate method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of the clavulanic acid dimer impurity in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling in β-lactamase inhibitor formulations.
• Stability Studies & Forced Degradation: Used to monitor and quantify the formation of this specific dimer impurity during drug product stability testing under various ICH conditions (heat, humidity, light).
• Quality Control & Batch Release Testing: Employed as a system suitability standard and for preparing calibration curves to ensure impurity levels in commercial batches meet stringent pharmacopeial specifications (USP, EP, BP).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds, justify specifications, and demonstrate control of the manufacturing process.
• Process Chemistry Research: Aids chemists in understanding and minimizing the formation of this dimer during the synthesis, purification, and storage of clavulanic acid and its salts.

Basic Information

Product Name	Clavulanic Acid Dimer Impurity
CAS No.	1260617-10-4
Molecular Formula	C16H18N2O10
Molecular Weight	398.32 g/mol
Synonyms	(2R,3Z,5R)-3-(2-Hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Dimer; Clavulanate Dimer; Clavulanic Acid Dimer; Dimer of Clavulanic Acid; Clavulanic Acid Dimer Related Compound; Amoxicillin-Clavulanate Impurity Dimer; Potassium Clavulanate Dimer Impurity
EINECS	Contact for details

Quality Control

Every batch of Clavulanic Acid Dimer Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial and internal specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use in GMP and regulatory environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to prevent degradation. For long-term storage, consider desiccant use and storage under an inert atmosphere.

Specification

Item	Specification
Appearance	White to Off-white Solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to Reference Spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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