Description

Rac-Lipoic Acid Impurity 1 (S-Oxide) is a critical reference standard used in the pharmaceutical development and quality control of α-lipoic acid (ALA) and its related drug substances. This compound is essential for the accurate identification, quantification, and monitoring of the S-oxide impurity during the manufacturing process. It is primarily utilized by analytical chemists and quality assurance professionals in the pharmaceutical and nutraceutical industries to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Rac-Lipoic Acid (ALA) active pharmaceutical ingredients (APIs).
• Analytical Method Development: Used to develop and optimize chromatographic methods (e.g., HPLC, UPLC) for the precise separation and detection of the S-oxide impurity from the main drug substance.
• Stability Studies: Employed as a marker to assess the degradation profile of α-lipoic acid formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Nutraceutical Quality Assurance: Applied in the quality control of high-purity α-lipoic acid dietary supplements to verify impurity levels meet stringent specifications.
• Research & Development: Used in academic and industrial R&D to study the metabolism, pharmacokinetics, and chemical behavior of lipoic acid derivatives.

Basic Information

Product Name	Rac-Lipoic Acid Impurity 1 (S-Oxide)
CAS No.	108015-78-7
Molecular Formula	C8H14O2S2
Molecular Weight	206.33 g/mol
Synonyms	DL-α-Lipoic Acid S-Oxide; (±)-α-Lipoic Acid Sulfoxide; 1,2-Dithiolane-3-pentanoic acid, 1-oxide; Thioctic Acid S-Oxide; 5-(1,2-Dithiolan-3-yl)pentanoic acid S-oxide; ALA Impurity S-Oxide; Racemic Lipoic Acid Sulfoxide Impurity; 6,8-Thioctic Acid S-Oxide
EINECS	Contact for details

Quality Control

Every batch of Rac-Lipoic Acid Impurity 1 (S-Oxide) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation and purity assessment using advanced analytical techniques including HPLC, NMR, and mass spectrometry to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light).

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%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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