Description

Topiramate Impurity 6 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Topiramate. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for Topiramate-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Topiramate API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to confirm that Topiramate meets stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Aids in understanding the degradation pathways and chemical behavior of Topiramate during synthesis and formulation processes.

Basic Information

Product Name	Topiramate Impurity 6
CAS No.	950603-46-0
Molecular Formula	C12H21NO8S
Molecular Weight	339.36 g/mol
Synonyms	Topiramate Related Compound 6; 2,3:4,5-Bis-O-(1-methylethylidene)-β-D-fructopyranose sulfamate; 1-Deoxy-1-(sulfamoylamino)-2,3:4,5-bis-O-(1-methylethylidene)-D-fructopyranose; D-Fructose, 1-deoxy-1-(sulfamoylamino)-, 2,3:4,5-bis-O-(1-methylethylidene)-; Topiramate Impurity F (potential); Topiramate Sulfamate Impurity
EINECS	Contact for details

Quality Control

Every batch of Topiramate Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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