Description

R-Lipoic Acid Impurity 2 (S-Oxide) is a specified impurity of the essential metabolic cofactor R-(+)-α-Lipoic Acid (ALA). This compound is of critical importance for pharmaceutical manufacturers and analytical laboratories engaged in the development and quality control of ALA-based drug substances and formulations. It serves as a vital reference standard for ensuring product purity, meeting stringent regulatory requirements, and validating analytical methods. Professionals in pharmaceutical R&D, quality assurance (QA), and contract research organizations (CROs) require this high-purity impurity to guarantee the safety and efficacy of their final products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of R-Lipoic Acid impurities in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control (QC) Testing: Used in routine QC laboratories to establish specification limits and ensure batch-to-batch consistency of R-Lipoic Acid drug substances.
• Stability Studies: Employed to track the formation of degradation products in R-Lipoic Acid formulations under various stress conditions (e.g., heat, light) as part of ICH stability protocols.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., Drug Master Files, CMC sections) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research on Metabolism and Degradation Pathways: Utilized in academic and industrial research to study the oxidation pathways and metabolic fate of lipoic acid.

Basic Information

Product Name	R-Lipoic Acid Impurity 2 (S-Oxide)
CAS No.	188783-96-2
Molecular Formula	C8H14O2S2
Molecular Weight	206.33 g/mol
Synonyms	(R)-α-Lipoic Acid S-Oxide; (R)-1,2-Dithiolane-3-pentanoic acid 1-oxide; R-ALA S-Oxide; R-(+)-Thioctic Acid Impurity 2; R-(+)-α-Lipoic Acid Sulfoxide; R-Lipoic Acid Sulfoxide Impurity; 5-(1,2-Dithiolan-3-yl)pentanoic acid S-oxide (R-enantiomer); (R)-6,8-Dithiooctanoic acid 1-oxide
EINECS	Contact for details

Quality Control

Our R-Lipoic Acid Impurity 2 (S-Oxide) is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for use as a reference standard. Quality is assured through comprehensive characterization via HPLC, NMR, and MS. A detailed Certificate of Analysis (COA) is provided with each batch, documenting purity, identity, and chromatographic profile. Our quality system is designed to support pharmaceutical development and compliance with current Good Manufacturing Practice (cGMP) principles where applicable.

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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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