Description

Eletriptan Impurity 2 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Eletriptan by serving as a key marker for impurity profiling and method validation. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers focused on regulatory compliance and product quality assurance.

Application

• Pharmaceutical Impurity Reference Standard for the identification and quantification of related substances in Eletriptan API and finished drug products.
• Analytical Method Development and Validation (HPLC, LC-MS) to establish specificity, accuracy, and detection limits.
• Quality Control (QC) and Stability Testing to monitor impurity levels throughout the drug product lifecycle.
• Regulatory Documentation and Submission to agencies like the FDA and EMA, providing necessary impurity characterization data.
• Research and Development for studying the degradation pathways and metabolism of Eletriptan.
• Calibration of Analytical Instruments to ensure accurate and reproducible results in impurity analysis.

Basic Information

Product Name	Eletriptan Impurity 2
CAS No.	1181222-90-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Eletriptan Related Compound 2; Eletriptan Impurity B; Eletriptan EP Impurity B; (3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-(2-phenylsulfonylethyl)-1H-indole); UNII-9R4F5TZ8UQ
EINECS	Contact for details

Quality Control

Our Eletriptan Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity and identity confirmation, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, assay results, and chromatographic data. Our quality commitment aligns with ICH Q3A, Q3B, and pharmacopeial guidelines (USP, EP) for impurities.

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

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)	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.