Description

10-Hydroxy Topiramate is a key pharmaceutical intermediate and metabolite of the anticonvulsant drug Topiramate. This compound is of significant importance for research and development in the field of neurology and drug metabolism studies. It is primarily utilized by pharmaceutical manufacturers and analytical laboratories for the synthesis of advanced drug formulations and as a critical reference standard in bioanalytical testing.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis and development of advanced Topiramate-based therapeutics.
• Reference Standard: Used as a certified reference material (CRM) in analytical laboratories for method development, validation, and quality control of Topiramate drug substances and products.
• Metabolite Studies: Essential for pharmacokinetic and pharmacodynamic research to understand the metabolism, efficacy, and safety profile of Topiramate.
• Impurity Profiling: Employed in the identification and quantification of related substances during the manufacturing process to ensure drug purity and compliance with ICH guidelines.
• Active Pharmaceutical Ingredient (API) Development: Serves as a precursor in the research and scale-up production of new neuroactive drug formulations.

Basic Information

Product Name	10-Hydroxy Topiramate
CAS No.	198215-60-0
Molecular Formula	C12H21NO8S
Molecular Weight	339.36 g/mol
Synonyms	10-Hydroxytopiramate; Topiramate Metabolite; 2,3:4,5-Bis-O-(1-methylethylidene)-β-D-fructopyranose sulfamate, 10-hydroxy derivative; (4aS,5aR,8S,8aS,9R)-8-Hydroxy-2,3:4,5-bis-O-(1-methylethylidene)-β-D-fructopyranose sulfamate; 10-OH-Topiramate; Topiramate Hydroxy Metabolite
EINECS	Contact for details

Quality Control

Our 10-Hydroxy Topiramate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and NMR, and residual solvent analysis to ensure it meets high-purity standards suitable for pharmaceutical research. Certificates of Analysis (COA) with detailed chromatographic data are provided for every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). 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 powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 1.0%

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