Description

Rac-Lipoic Acid Impurity 3 (S-Oxide) is a specified impurity of the essential metabolic cofactor, α-lipoic acid. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control of lipoic acid active pharmaceutical ingredients (APIs). It is primarily required by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical and nutraceutical industries to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the S-oxide impurity in α-lipoic acid drug substances and finished products.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing to ensure lipoic acid APIs and formulations meet pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., oxidative stress) during drug stability testing.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research on Lipoic Acid Chemistry: Serves as a tool for academic and industrial research studying the oxidation pathways and metabolism of α-lipoic acid.

Basic Information

Product Name	Rac-Lipoic Acid Impurity 3 (S-Oxide)
CAS No.	17370-41-1
Molecular Formula	C8H14O2S2
Molecular Weight	206.32 g/mol
Synonyms	DL-α-Lipoic Acid S-Oxide; (±)-1,2-Dithiolane-3-pentanoic acid 1-oxide; 5-(1,2-Dithiolan-3-yl)pentanoic acid S-oxide; Racemic Lipoic Acid Sulfoxide; Thioctic Acid Impurity 3 (S-Oxide); 6,8-Thioctic Acid S-Oxide; (±)-Lipoic Acid S-Oxide
EINECS	Contact for details

Quality Control

Every batch of Rac-Lipoic Acid Impurity 3 (S-Oxide) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is easily oxidized; for long-term storage, consider storing under an inert atmosphere such as argon or nitrogen. Keep the container tightly sealed in a dry and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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