Description

R-Lipoic Acid Impurity 1 (S-Oxide) is a specified impurity of the biologically active R-Lipoic Acid (α-Lipoic Acid). This compound is of critical importance in the pharmaceutical industry for analytical method development, quality control, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development, validation, and production of high-purity R-Lipoic Acid drug substances and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the S-Oxide impurity in R-Lipoic Acid Active Pharmaceutical Ingredients (APIs) and finished products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles during drug substance synthesis and formulation stability studies.
• Quality Control & Batch Release: Serves as a system suitability standard and for preparing calibration curves to ensure the impurity levels in commercial batches comply with pharmacopeial (e.g., USP, EP) or internal specifications.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., oxidative stress), supporting drug shelf-life determination.
• Regulatory Submissions: Critical for preparing impurity profiles and analytical data packages required for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Process Chemistry Research: Used by chemists to study and optimize synthesis pathways to minimize the formation of this impurity during the manufacturing of R-Lipoic Acid.

Basic Information

Product Name	R-Lipoic Acid Impurity 1 (S-Oxide)
CAS No.	188745-24-6
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)-6,8-Thioctic acid S-oxide; R-ALA S-Oxide; R-Thioctic Acid Impurity 1; R-α-Lipoic Acid Sulfoxide; R-5-(1,2-Dithiolan-3-yl)pentanoic acid S-oxide; (R)-5-[3-(1,2-Dithiolanyl)]pentanoic acid S-oxide
EINECS	Contact for details

Quality Control

This high-purity analytical standard is manufactured under controlled conditions and undergoes rigorous multi-point quality testing. Each batch is characterized and qualified using advanced analytical techniques including HPLC, NMR, and Mass Spectrometry to confirm identity, purity, and impurity profile. A comprehensive Certificate of Analysis (CoA) is supplied with each shipment, detailing batch-specific results. Our quality system supports compliance with GMP/GLP principles for use in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at 2-8°C. The container should be kept in a cool, dry, and well-ventilated area. Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
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.