Description

Glycyrrhetic Acid Impurity 2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and method validation of pharmaceutical products derived from or containing glycyrrhetic acid. It is primarily required by analytical laboratories, quality assurance departments, and research institutions in the pharmaceutical and phytochemical industries to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material (CRM) for identifying and quantifying this specific impurity in active pharmaceutical ingredients (APIs) and finished drug products containing glycyrrhetic acid.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for accurate impurity detection.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to monitor batch-to-batch consistency and ensure impurities are controlled within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Used as a marker to track the formation of degradation products in stability testing of glycyrrhetic acid and related formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Supports pharmacological and metabolic studies investigating the properties and pathways of glycyrrhetic acid and its derivatives.

Basic Information

Product Name	Glycyrrhetic Acid Impurity 2
CAS No.	67951-04-6
Molecular Formula	C30H46O4
Molecular Weight	470.69 g/mol
Synonyms	18β-Glycyrrhetinic Acid Impurity 2; 3-Oxo-11,13(18)-oleanadien-30-oic acid; 18-Dehydroglycyrrhetic acid; 11,13(18)-Didehydroglycyrrhetinic acid; 18β-Hydroxy-11,13(18)-oleanadien-30-oic acid (related); Glycyrrhetinic acid derivative; Enoxolone impurity; (11β)-11-Hydroxy-3-oxoolean-12-en-30-oic acid (isomer)
EINECS	Contact for details

Quality Control

Every batch of Glycyrrhetic Acid Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced analytical techniques including HPLC, GC, MS, and NMR to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality requirements.

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 in a dry environment to prevent degradation.

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%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Loss on Drying	≤ 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.