Description

Thioctic Acid Impurity 25 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Thioctic Acid (α-Lipoic Acid). It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference material for the identification and quantification of specific impurities in Thioctic Acid (α-Lipoic Acid) Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for accurate impurity detection.
• Quality Assurance and Control (QA/QC): Essential for routine batch testing in pharmaceutical manufacturing to ensure product purity meets stringent pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to monitor the formation of degradation products in Thioctic Acid formulations under various stress conditions.
• Regulatory Compliance and Documentation: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity understanding and control strategies.
• Research and Development: Used in metabolic and pharmacokinetic studies to understand the degradation pathways of Thioctic Acid.

Basic Information

Product Name	Thioctic Acid Impurity 25
CAS No.	2114407-83-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	α-Lipoic Acid Impurity 25; Lipoic Acid Impurity 25; 1,2-Dithiolane-3-pentanoic acid impurity 25; ALA Impurity 25; Thioctacid Impurity 25; (R)-5-(1,2-Dithiolan-3-yl)pentanoic acid related compound 25
EINECS	Contact for details

Quality Control

Every batch of Thioctic Acid Impurity 25 is manufactured and controlled under a strict quality management system. Our products undergo rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and major pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

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