Description

Thioctic Acid Impurity 23 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and method development of pharmaceutical products containing Thioctic Acid (α-Lipoic Acid). It is primarily utilized by analytical chemists and quality assurance professionals in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors to ensure product purity and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of related substances 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, such as HPLC and UPLC, for purity analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to monitor impurity levels against established specifications, ensuring batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Used to track the formation of degradation products in Thioctic Acid formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research and Development: Supports metabolic studies, pharmacokinetic research, and the synthesis of novel Thioctic Acid derivatives in academic and industrial R&D settings.

Basic Information

Product Name	Thioctic Acid Impurity 23
CAS No.	6718-96-3
Molecular Formula	C8H14O2S2
Molecular Weight	206.33 g/mol
Synonyms	1,2-Dithiolane-3-pentanoic acid impurity; 6,8-Bis(methylthio)octanoic acid; 6,8-Dimercaptooctanoic acid derivative; α-Lipoic Acid Related Compound; (±)-6,8-Dithiooctanoic acid impurity; DL-6,8-Thioctic Acid Impurity; 5-(1,2-Dithiolan-3-yl)pentanoic acid analog
EINECS	Contact for details

Quality Control

Our Thioctic Acid Impurity 23 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is subjected to comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR) and purity determination by advanced chromatographic techniques (HPLC). A Certificate of Analysis (COA) detailing batch-specific results is provided to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential oxidation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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