Description

Thioctic Acid Impurity 20 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Thioctic Acid (α-Lipoic Acid). It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference material for the identification and quantification of specific impurities in Thioctic Acid Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for quality control testing.
• Stability Studies: Employed to monitor the formation of degradation products in Thioctic Acid formulations under various stress conditions.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Chemical Research and Synthesis: Acts as a key intermediate or reference compound in the research and synthesis of Thioctic Acid analogs and related molecules.
• Quality Assurance/Quality Control (QA/QC): Provides an external standard for routine batch release testing to ensure product specifications are met.

Basic Information

Product Name	Thioctic Acid Impurity 20
CAS No.	2114407-78-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	α-Lipoic Acid Impurity 20; Lipoic Acid Impurity 20; 1,2-Dithiolane-3-pentanoic acid impurity; 6,8-Thioctic Acid Related Compound 20; (R)-5-(1,2-Dithiolan-3-yl)pentanoic acid impurity; ALA Impurity 20; Thioctacid Impurity 20
EINECS	Contact for details

Quality Control

Every batch of Thioctic Acid Impurity 20 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing using advanced analytical techniques to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, impurities, and other critical parameters. We support compliance with ICH guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis/label. Keep the container in a dry, cool, and well-ventilated place. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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