Description

Topiramate Impurity 8 is a specified impurity and reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Topiramate. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of this specific impurity during manufacturing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Topiramate Impurity 8 in Topiramate API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure API batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate control strategies for known and potential impurities.
• Research & Development: Used in R&D to study the degradation pathways and chemistry of Topiramate, aiding in process optimization and impurity control.

Basic Information

Product Name	Topiramate Impurity 8
CAS No.	32785-90-3
Molecular Formula	C12H21NO8S
Molecular Weight	339.36 g/mol
Synonyms	2,3:4,5-Bis-O-(1-methylethylidene)-β-D-fructopyranose sulfamate; Topiramate Related Compound B; Topiramate Sulfamate Ester Impurity; 1,2:3,4-Di-O-isopropylidene-β-D-fructopyranose 1-sulfamate; Fructopyranose, 2,3:4,5-bis-O-(1-methylethylidene)-, 1-(aminosulfonate), β-D-; Topiramate Impurity B; Topiramate EP Impurity B
EINECS	Contact for details

Quality Control

Every batch of Topiramate Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for purity, related substances, residual solvents, and other critical parameters.

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, which may affect stability and analytical performance.

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 unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Assay (HPLC)	97.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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