Description

Topiramate Didesacetal Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of the antiepileptic drug Topiramate. This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification and quantification during analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analytical testing of Topiramate active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Essential for developing and validating sensitive HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control and Assurance: Used in routine QC testing to ensure Topiramate batches meet specified purity limits as per ICH, USP, or EP guidelines.
• Stability Studies: Employed to identify and track degradation products in forced degradation and long-term stability studies of Topiramate.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization.
• Research and Development: Utilized in synthetic chemistry R&D to understand and control the formation of this specific impurity during the Topiramate manufacturing process.

Basic Information

Item	Details
Product Name	Topiramate Didesacetal Impurity
CAS No.	106881-42-9
Molecular Formula	C12H21NO8S
Molecular Weight	339.36 g/mol
Synonyms	2,3:4,5-Bis-O-(1-methylethylidene)-β-D-fructopyranose sulfamate; Topiramate Diketal Impurity; Topiramate Related Compound; 1,2:3,4-Di-O-isopropylidene-β-D-fructopyranose sulfamate; Didesacetal Topiramate; Topiramate Impurity F (Potential); Fructopyranose, 2,3:4,5-bis-O-(1-methylethylidene)-, sulfamate
EINECS	Contact for details

Quality Control

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

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.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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