Description

Topiramate n-Methyl Impurity is a critical pharmaceutical reference standard used in the quality control and analytical development of the anticonvulsant drug Topiramate. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by serving as a known marker for a specific synthetic byproduct. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of the n-Methyl impurity in Topiramate Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation (HPLC/GC): Serves as a critical component in developing and validating chromatographic methods for Topiramate purity analysis.
• Stability Indicating Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control & Batch Release Testing: A necessary standard for routine QC testing to ensure each batch of Topiramate API meets the specified impurity limits.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity characterization data required by agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry R&D to study and optimize the Topiramate manufacturing process to minimize this impurity.

Basic Information

Product Name	Topiramate n-Methyl Impurity
CAS No.	97240-80-7
Molecular Formula	C13H21NO8S
Molecular Weight	351.37 g/mol
Synonyms	N-Methyl Topiramate; 2,3:4,5-Bis-O-(1-methylethylidene)-β-D-fructopyranose Sulfamate, N-Methyl Derivative; Topiramate Related Compound C; Topiramate Impurity C; Topiramate EP Impurity C; 1-Methylamino Sulfamoyl-2,3:4,5-bis-O-(1-methylethylidene)-β-D-fructopyranose
EINECS	Contact for details

Quality Control

Our Topiramate n-Methyl Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized and confirmed by advanced spectroscopic and chromatographic techniques (HPLC, GC-MS, NMR). A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

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%
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.