Description

Thioctic Acid Impurity CAS NO 25636-58-2 is a high-purity reference standard critical for analytical research and quality control in pharmaceutical development. This compound is essential for the accurate identification, quantification, and monitoring of related substances in Thioctic Acid (α-Lipoic Acid) active pharmaceutical ingredients (APIs) and finished drug products. It is primarily used by researchers, analytical chemists, and quality assurance professionals in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material (CRM) for method development and validation in HPLC, UPLC, and GC analysis of Thioctic Acid.
• Quality Control & Assurance (QC/QA): Used as a system suitability standard and for quantifying specified and unspecified impurities in API batches to meet ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (heat, light, humidity) for drug substance and product stability testing.
• Regulatory Submissions: Provides essential data for impurity identification and qualification reports required for FDA, EMA, and other global regulatory agency filings.
• Metabolite Research: Acts as a potential intermediate or reference standard in metabolic pathway studies of α-Lipoic Acid.
• Chemical Synthesis: May be used as an intermediate or starting material in the research-scale synthesis of novel Thioctic Acid analogs or derivatives.

Basic Information

Product Name	Thioctic Acid Impurity
CAS No.	25636-58-2
Molecular Formula	C8H14O2S2
Molecular Weight	206.33 g/mol
Synonyms	6,8-Dimercaptooctanoic Acid; Dihydrolipoic Acid Impurity; Reduced Lipoic Acid Impurity; 1,2-Dithiolane-3-pentanoic Acid, dihydro-; DL-Dihydrolipoate; 6,8-Bis(sulfanyl)octanoic acid; R/S-Dihydrolipoic Acid; Thioctacid Impurity
EINECS	Contact for details

Quality Control

Every batch of our Thioctic Acid Impurity is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) containing batch-specific data, traceable to primary standards, is provided with each shipment to support your regulatory and research needs.

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 product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to minimize exposure to atmospheric humidity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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