Description

Sumatriptan Ep Impurity F is a high-purity reference standard critical for pharmaceutical research and development. This compound is essential for the analytical characterization and quality control of Sumatriptan succinate, a widely used migraine medication. It serves as a key impurity marker to ensure drug safety, efficacy, and regulatory compliance. Pharmaceutical manufacturers, analytical laboratories, and regulatory bodies require this standard for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Sumatriptan succinate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels throughout the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Employed in routine quality control laboratories to establish acceptance criteria and ensure batch-to-batch consistency of Sumatriptan-based products.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to determine drug shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity control strategies as per ICH guidelines.
• Research and Development: Supports synthetic route optimization and process chemistry research to minimize impurity formation during API synthesis.

Basic Information

Product Name	Sumatriptan Ep Impurity F
CAS No.	2074615-63-5
Molecular Formula	C14H21N3O2S
Molecular Weight	295.40 g/mol
Synonyms	1-[3-(2-Dimethylaminoethyl)-1H-indol-5-yl]-N-methylmethanesulfonamide Ep Impurity F; Sumatriptan Related Compound F; Sumatriptan EP Impurity F; Sumatriptan Succinate Impurity F; 1H-Indole-5-methanesulfonamide, 3-[2-(dimethylamino)ethyl]-N-methyl-; (3-(2-(Dimethylamino)ethyl)-1H-indol-5-yl)-N-methylmethanesulfonamide; Sumatriptan Impurity F (EP); Sumatriptan Process Impurity F
EINECS	Contact for details

Quality Control

Every batch of Sumatriptan Ep Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopoeial guidelines (EP, USP). Comprehensive characterization is performed using advanced techniques like HPLC, GC, MS, NMR, and IR spectroscopy. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided with each shipment and are available upon request.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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