Description

Thioctic Acid Impurity 38 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products containing α-lipoic acid (thioctic acid). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in α-lipoic acid (thioctic acid) active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels in compliance with ICH guidelines.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and that impurity levels remain within specified pharmacopeial limits (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products in α-lipoic acid formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Facilitates metabolic and pharmacokinetic studies by helping to characterize related substances in biological matrices.

Basic Information

Product Name	Thioctic Acid Impurity 38
CAS No.	91009-30-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	α-Lipoic Acid Impurity 38; 1,2-Dithiolane-3-pentanoic acid impurity; 6,8-Thioctic Acid Related Compound 38; Lipoic Acid Impurity 38; 5-[3-(1,2-Dithiolan-3-yl)propyl]pentanoic acid (proposed); Thioctacid Impurity; Tioctic Acid Impurity
EINECS	Contact for details

Quality Control

Every batch of Thioctic Acid Impurity 38 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and mass spectrometry to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatographic data, and storage conditions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material should be kept in a dry environment to prevent moisture uptake.

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 impurity: ≤ 1.0% 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.