Description

Clavulanic Acid Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of clavulanic acid and its related pharmaceutical formulations through precise impurity profiling. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and regulatory affairs teams. The material is essential for method development, validation, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Clavulanic Acid Impurity 1 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: A critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis in clavulanate potassium and amoxicillin-clavulanate combination drugs.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels, ensuring batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Compliance & Filings: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used to track the formation and increase of this specific impurity during forced degradation and long-term stability studies of clavulanic acid.
• Research & Development: Facilitates studies on the degradation pathways, synthesis impurities, and metabolic profiling of β-lactamase inhibitor compounds.

Basic Information

Product Name	Clavulanic Acid Impurity 1
CAS No.	2196185-67-6
Molecular Formula	C8H9NO5
Molecular Weight	199.16 g/mol
Synonyms	(2R,3Z,5R)-3-(2-Hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; Clavulanate Impurity 1; Clavulanic Acid Related Compound 1; (5R)-3-(2-Hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid; Clavulanic Acid Degradant; Clavulanic Acid EP Impurity 1
EINECS	Contact for details

Quality Control

Our Clavulanic Acid Impurity 1 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analysis. The material is suitable for use as a reference standard in compliance with ICH, USP, and EP guidelines for impurity identification.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
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.