Description

Thioctic Acid Impurity 26 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 required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used 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 & Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH Q3A/B guidelines.
• Quality Control & Assurance: Employed in routine quality control testing to monitor and control impurity levels, ensuring batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Thioctic Acid formulations.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Supports synthetic chemistry and metabolic pathway research related to Thioctic Acid and its derivatives.

Basic Information

Product Name	Thioctic Acid Impurity 26
CAS No.	2114407-82-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	ALA Impurity 26; α-Lipoic Acid Impurity 26; 1,2-Dithiolane-3-pentanoic acid impurity 26; Thioctacid Impurity 26; 6,8-Thioctic Acid Impurity 26; Lipoyl Impurity 26; (R)-5-(1,2-Dithiolan-3-yl)pentanoic acid related compound 26
EINECS	Contact for details

Quality Control

Our Thioctic Acid Impurity 26 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment supports your regulatory and research requirements.

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. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.