Description

Clavulanic Acid Impurity 6 Dihcl is a high-purity chemical reference standard, specifically identified as a dihydrochloride salt impurity of Clavulanic Acid. This compound is critical for pharmaceutical research and development, serving as a key marker for ensuring the purity, safety, and efficacy of β-lactamase inhibitor formulations. It is primarily utilized by analytical chemists, quality control laboratories, and regulatory affairs professionals within the global pharmaceutical and biotechnology sectors for method development, validation, and compliance testing.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Clavulanic Acid and its drug product formulations like Augmentin.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this impurity under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life.
• Regulatory Compliance and Submission: Essential for generating data to meet stringent regulatory requirements from agencies like the FDA, EMA, and ICH for drug approval and post-market surveillance.
• Quality Control and Batch Release Testing: Acts as a system suitability standard and for preparing calibration curves to ensure the purity of active pharmaceutical ingredients (APIs).
• Research on Degradation Pathways: Used in academic and industrial research to study the chemical degradation mechanisms of Clavulanic Acid.

Basic Information

Product Name	Clavulanic Acid Impurity 6 Dihcl
CAS No.	295796-12-2
Molecular Formula	C8H11NO5 • 2HCl
Molecular Weight	282.09 g/mol (Free base: 201.18)
Synonyms	(2R,3Z,5R)-3-(2-Hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic acid dihydrochloride; Clavulanate Impurity 6 Dihydrochloride; Clavulanic Acid Dihydrochloride Impurity 6; Clavulanic Acid Related Compound 6 Dihydrochloride; 295796-12-2; Clavulanic Acid EP Impurity 6 Dihydrochloride
EINECS	Contact for details

Quality Control

Every batch of Clavulanic Acid Impurity 6 Dihcl is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation (IR, 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 assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature between 15-25°C. This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a cool, dry place to maintain stability and purity. For long-term storage, consider desiccants and 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)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%

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