Description

Lipoic Acid Impurity 46 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing α-lipoic acid (ALA). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification in α-lipoic acid (ALA) drug substances and finished products.
• Analytical Method Development and Validation for HPLC, UPLC, and LC-MS systems.
• Stability Studies and Forced Degradation Studies to monitor impurity formation over time.
• Quality Control (QC) and Quality Assurance (QA) as a certified reference material for in-house testing.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA, EMA, and ICH.
• Research and Development into the metabolism, pharmacokinetics, and degradation pathways of lipoic acid.

Basic Information

Product Name	Lipoic Acid Impurity 46
CAS No.	2635383-46-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	ALA Impurity 46; α-Lipoic Acid Impurity 46; Thioctic Acid Impurity 46; 1,2-Dithiolane-3-pentanoic acid impurity; (R)-5-(1,2-Dithiolan-3-yl)pentanoic acid related compound; Lipoic Acid Related Compound 46; Pharmaceutical Impurity Standard 2635383-46-7
EINECS	Contact for details

Quality Control

Our Lipoic Acid Impurity 46 is manufactured under strict quality systems to ensure the highest standards of purity and traceability. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic analyses. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

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, 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)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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