Description

Oxotiagabine Tosylate is a high-purity pharmaceutical intermediate and reference standard of significant importance in modern drug development and research. Its primary value lies in its role as a key derivative of the anticonvulsant agent Tiagabine, enabling critical studies in neuroscience and pharmacology. This compound is essential for researchers and manufacturers in the pharmaceutical industry, particularly those focused on developing and analyzing central nervous system (CNS) therapeutics, neurological disorder treatments, and novel active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quality control and assay validation of Tiagabine-based drug products.
• Active Pharmaceutical Ingredient (API) Intermediate: Serves as a critical precursor in the synthesis and scale-up manufacturing of the anticonvulsant drug Tiagabine Hydrochloride.
• Neuroscience Research: Employed in preclinical and clinical research to study GABA (γ-aminobutyric acid) reuptake inhibition mechanisms and their effects on seizure activity.
• Analytical Method Development: Utilized in HPLC, LC-MS, and other chromatographic methods for developing and validating analytical procedures for CNS drugs.
• Impurity Profiling: Acts as a known impurity or degradation product standard to ensure the purity and stability of final drug formulations.
• Regulatory Submissions: Provides essential data and material for regulatory documentation required by agencies such as the FDA and EMA.

Basic Information

Product Name	Oxotiagabine Tosylate
CAS No.	161014-56-8
Molecular Formula	C21H25NO5S
Molecular Weight	403.49 g/mol
Synonyms	(R)-(-)-N-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic Acid Oxalate Tosylate Salt; (R)-(-)-N-[4,4-Di(3-methyl-2-thienyl)-3-buten-1-yl]nipecotic Acid Oxalate p-Toluenesulfonate; Oxotiagabine p-Toluenesulfonate; Tiagabine Related Compound F (Tosylate Salt); (3R)-1-[4,4-Bis(3-methyl-2-thienyl)but-3-en-1-yl]piperidine-3-carboxylic Acid 2-Hydroxypropane-1,2,3-tricarboxylate Tosylate
EINECS	Contact for details

Quality Control

Our Oxotiagabine Tosylate is manufactured under strict quality management systems to ensure it meets the rigorous standards required for pharmaceutical research and development. Each batch undergoes comprehensive analytical testing, including identification, purity assay, and impurity profiling via advanced techniques like HPLC and LC-MS. Certificates of Analysis (COA) are provided with every shipment, detailing all specifications and test results to support your regulatory and quality assurance 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). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single impurity ≤0.5%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

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