Description

Frovatriptan Impurity 6 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Frovatriptan. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker for identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of migraine treatments.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Frovatriptan Impurity 6 in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor impurity levels and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Frovatriptan Impurity 6
CAS No.	29280-23-7
Molecular Formula	C14H17N3O2
Molecular Weight	259.31 g/mol
Synonyms	Frovatriptan Related Compound 6; 3-(Methylamino)-1-[[3-(1H-pyrrol-1-yl)-1H-indol-5-yl]methyl]pyrrolidin-2-one; 1H-Indole-5-methanol, 3-(1H-pyrrol-1-yl)-α-[(2-oxo-3-pyrrolidinyl)methyl]amino]-, (αR)-; (R)-3-((((3-(1H-Pyrrol-1-yl)-1H-indol-5-yl)methyl)(methyl)amino)methyl)dihydrofuran-2(3H)-one; Frovatriptan EP Impurity G; Frovatriptan USP Impurity 6
EINECS	Contact for details

Quality Control

Our Frovatriptan Impurity 6 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including identification (HPLC, IR), assay (by HPLC), and related substance analysis. The material is suitable for use as a reference standard in compliance with current pharmacopeial (USP, EP) and ICH guidelines.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.