Description

Topiramate Impurity 6 is a specified, structurally characterized impurity used in the quality control and analytical development of the anticonvulsant drug Topiramate. This high-purity reference standard is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily used for method validation, stability studies, and batch release testing in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Topiramate drug substance and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling.
• Stability Indicating Method: Employed in forced degradation and long-term stability studies to monitor impurity levels in Topiramate formulations.
• Quality Control (QC) Testing: Essential for routine batch release testing to confirm impurity levels are within International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for health authorities like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and improve manufacturing processes.

Basic Information

Product Name	Topiramate Impurity 6
CAS No.	876403-98-4
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 6; Topiramate EP Impurity 6; Topiramate USP Impurity 6; 1-Deoxy-1-(sulfamoylamino)-2,3:4,5-bis-O-(1-methylethylidene)-D-fructopyranose; Topiramate Degradant; Topiramate Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Topiramate Impurity 6 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and consistency. Our quality system is designed to meet the stringent requirements of pharmaceutical reference standard applications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC purity, related substances, residual solvents, and spectroscopic identification (IR, NMR, MS). We support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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