Description

Sumatriptan Ep Impurity H is a high-purity reference standard critical for analytical research and quality control in pharmaceutical development. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities during the manufacture of Sumatriptan, a key medication for migraine treatment. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) engaged in method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for calibrating analytical instruments like HPLC and LC-MS in impurity profiling.
• Method Development and Validation: Used to develop, optimize, and validate chromatographic methods for the specific detection of Sumatriptan-related impurities.
• Quality Control and Batch Release: Enables precise quantification of Impurity H in active pharmaceutical ingredient (API) and finished drug product batches to ensure they meet stringent pharmacopeial limits (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation and level of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over the manufacturing process.
• Academic and Clinical Research: Supports investigative studies on the metabolism, degradation pathways, and safety profile of Sumatriptan.

Basic Information

Product Name	Sumatriptan Ep Impurity H
CAS No.	1391052-59-7
Molecular Formula	C14H21N3O2S
Molecular Weight	295.40 g/mol
Synonyms	1-[3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl]-N-methylmethanesulfonamide Ep Impurity; Sumatriptan EP Impurity H; Sumatriptan Impurity H; (3-(2-(Dimethylamino)ethyl)-1H-indol-5-yl)-N-methylmethanesulfonamide related compound H; 1391052-59-7
EINECS	Contact for details

Quality Control

Every batch of Sumatriptan Ep Impurity H is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided and available upon request to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

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

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