Description

Thioctic Acid Impurity 19 is a high-purity chemical reference standard, specifically identified as an impurity of the pharmaceutical compound α-Lipoic Acid (Thioctic Acid). This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily required by research institutions, analytical laboratories, and pharmaceutical companies engaged in the synthesis, purification, and regulatory compliance of Thioctic Acid-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in α-Lipoic Acid (Thioctic Acid) Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, to separate and analyze Thioctic Acid and its process-related impurities.
• Quality Control & Assurance: Employed in routine batch release testing to ensure API purity meets pharmacopeial standards (e.g., USP, EP) and internal specifications.
• Stability Studies: Used to monitor the formation of degradation impurities in Thioctic Acid under various stress conditions (e.g., heat, light, humidity) for drug stability profiling.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Process Chemistry Research: Aids chemists in understanding and controlling impurity formation during the synthesis and purification steps of Thioctic Acid manufacturing.

Basic Information

Product Name	Thioctic Acid Impurity 19
CAS No.	2114407-76-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	α-Lipoic Acid Impurity 19; 1,2-Dithiolane-3-pentanoic acid impurity 19; 6,8-Thioctic Acid Impurity 19; ALA Impurity 19; Lipoic Acid Impurity 19; (±)-α-Lipoic Acid Related Compound 19; 5-[3-(1,2-Dithiolan-3-yl)]pentanoic acid impurity; Thioctacid Impurity 19
EINECS	Contact for details

Quality Control

Every batch of Thioctic Acid Impurity 19 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and stability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

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 COA. 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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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