Description

4-[4-(2-Hydroxyethyl)-1H-Pyrrole-3-Carbonyloxymethyl]-1H-Pyrrole-3-Carboxylic Acid (Clavulanic Acid Impurity) is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound serves as a specified impurity in the analysis and validation of Clavulanic Acid, a key β-lactamase inhibitor used in combination antibiotic therapies. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable reference materials to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Clavulanic Acid Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and mass spectrometry methods in QC laboratories.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing data on impurity profiles as required by ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to monitor the formation and levels of this specific degradation product during forced degradation and long-term stability testing of Clavulanate Potassium formulations.
• Process Chemistry & Optimization: Employed in research and development to understand and minimize the formation of this impurity during the synthesis and purification of Clavulanic Acid.
• Quality Control Testing: Integral for routine batch release testing in pharmaceutical manufacturing to ensure impurity levels remain within specified limits.

Basic Information

Product Name	4-[4-(2-Hydroxyethyl)-1H-Pyrrole-3-Carbonyloxymethyl]-1H-Pyrrole-3-Carboxylic Acid (Clavulanic Acid Impurity)
CAS No.	1260857-16-6
Molecular Formula	C14H16N2O6
Molecular Weight	308.29 g/mol
Synonyms	Clavulanic Acid Impurity; Clavulanate Impurity; 4-[4-(2-Hydroxyethyl)-1H-pyrrole-3-carbonyloxymethyl]-1H-pyrrole-3-carboxylic acid; 1H-Pyrrole-3-carboxylic acid, 4-[4-(2-hydroxyethyl)-1H-pyrrole-3-carbonyloxymethyl]-; Clavulanic Acid Related Compound
EINECS	Contact for details

Quality Control

Our 4-[4-(2-Hydroxyethyl)-1H-Pyrrole-3-Carbonyloxymethyl]-1H-Pyrrole-3-Carboxylic Acid is manufactured under strict quality management systems. Each batch is subjected to rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment supports your regulatory and research requirements.

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 must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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