Description

Eletriptan Impurity 5 is a designated reference standard and analytical impurity used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) eletriptan hydrobromide. It is primarily required by analytical laboratories and quality control units within pharmaceutical and biotechnology companies. The material is essential for method validation, stability studies, and regulatory compliance filings.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of eletriptan API and related drug products.
• Method Development and Validation (HPLC/LC-MS): A critical component in developing and validating chromatographic methods for impurity profiling.
• Stability Indicating Studies: Employed to monitor the formation of this specific degradation product during forced degradation and long-term stability testing of eletriptan formulations.
• Quality Control and Batch Release: Serves as a system suitability and identification marker in the routine QC testing of eletriptan drug substance to ensure it meets pharmacopeial specifications.
• Regulatory Submission Support: Provides essential data for regulatory dossiers (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Process Chemistry Research: Used by R&D chemists to understand and optimize synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Eletriptan Impurity 5
CAS No.	3405-93-4
Molecular Formula	C22H26N2O2S
Molecular Weight	382.52 g/mol
Synonyms	Eletriptan Related Compound B; (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-(2-phenylsulfonylethyl)-1H-indole; UNII-9K3HX5KQ1F; Eletriptan Sulfone; Eletriptan EP Impurity B; Eletriptan USP Impurity B; Eletriptan Sulfoxide Impurity (Note: Confirm exact structure correlation)
EINECS	Contact for details

Quality Control

Every batch of Eletriptan Impurity 5 is manufactured and analyzed under strict quality management systems. The material is characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing purity, impurity profile, and analytical results. Our quality standards align with ICH guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C. Handle the material in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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