Description

Lipoic Acid Impurity A is a high-purity reference standard critical for analytical method development and quality control in pharmaceutical manufacturing. This compound is essential for ensuring the safety and efficacy of active pharmaceutical ingredients (APIs) containing α-lipoic acid by accurately identifying and quantifying related substances. It is primarily required by research institutions, quality control laboratories, and manufacturers engaged in the development and production of pharmaceuticals and nutraceuticals.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Lipoic Acid Impurity A in drug substances and finished products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities in α-lipoic acid APIs.
• Quality Control & Assurance: A critical tool for in-process testing and release testing of pharmaceutical batches to ensure compliance with ICH Q3A/B guidelines on impurities.
• Stability Studies: Employed to track the formation of degradation products in α-lipoic acid formulations under various storage conditions.
• Regulatory Submissions: Supports the filing of regulatory documents (e.g., DMF, CMC sections) by providing impurity characterization data for health authorities.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of α-lipoic acid.

Basic Information

Product Name	Lipoic Acid Impurity A
CAS No.	728854-75-9
Molecular Formula	C8H14O2S2
Molecular Weight	206.33 g/mol
Synonyms	1,2-Dithiolane-3-pentanoic acid impurity; Thioctic acid impurity A; (±)-α-Lipoic acid related compound A; 5-[3-(1,2-Dithiolan-3-yl)]pentanoic acid; DL-α-Lipoic acid impurity A; R/S-Lipoic acid impurity; 6,8-Thioctic acid impurity
EINECS	Contact for details

Quality Control

Our Lipoic Acid Impurity A is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural elucidation via NMR and MS, to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential oxidation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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