Description

Topiramate Impurity 13 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Topiramate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Topiramate API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure Topiramate batches meet stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of Topiramate formulations.
• Regulatory Submissions: Essential for preparing impurity data packages required for drug master files (DMFs), ANDAs, and other regulatory filings with agencies like the FDA and EMA.
• Research & Development: Utilized in R&D laboratories to study the degradation pathways and chemistry of Topiramate.

Basic Information

Item	Detail
Product Name	Topiramate Impurity 13
CAS No.	58238-46-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Topiramate Related Compound 13; Topiramate EP Impurity G; Topiramate USP Impurity; 2,3:4,5-Bis-O-(1-methylethylidene)-β-D-fructopyranose sulfamate (related compound); Topiramate Degradant; Topiramate Process Impurity; Topiramate Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Topiramate Impurity 13 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC purity assay and spectroscopic identification (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) with batch-specific data is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle the material with care to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specification
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.