Description

Eletriptan Impurity 7 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) eletriptan hydrobromide. This compound is critical for ensuring the purity, safety, and efficacy of eletriptan-based pharmaceutical formulations by providing a reference for identification and quantification. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory compliance teams focused on developing and manufacturing migraine therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in eletriptan API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Stability Studies: Used to monitor the formation of this specific degradant during forced degradation and long-term stability testing of eletriptan formulations.
• Regulatory Compliance and Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to establish impurity thresholds and control strategies as per ICH Q3A and Q3B guidelines.
• Quality Control Testing: Employed in routine batch release testing of eletriptan API to ensure it meets stringent pharmacopeial (e.g., USP, EP) or in-house specifications.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of eletriptan by identifying and controlling process-related impurities.

Basic Information

Product Name	Eletriptan Impurity 7
CAS No.	10230-79-2
Molecular Formula	C22H26N2O2S
Molecular Weight	382.52 g/mol
Synonyms	Eletriptan Related Compound 7; (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole; 1H-Indole, 3-[(1-methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-, (3R)-; Eletriptan Sulfone Impurity; Eletriptan EP Impurity G; UNII-9T3J8C8A2T
EINECS	Contact for details

Quality Control

Our Eletriptan Impurity 7 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is characterized using advanced techniques including HPLC, GC, MS, and NMR to confirm compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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