Description

Eletriptan Impurity 4 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Eletriptan. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It serves as a key reference standard for method development, validation, and routine batch testing in the production of migraine relief medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Eletriptan Hydrobromide API.
• Analytical Method Development: Used in developing and validating HPLC, UPLC, and GC methods for impurity profiling.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate control of impurities.
• Stability Studies: Employed to monitor the formation and levels of this specific impurity during drug product stability testing.
• Pharmacopoeial Testing: Supports testing to meet the specifications of pharmacopoeias such as USP, EP, and BP.
• Research & Development: Utilized in R&D to understand the degradation pathways and chemistry of Eletriptan.

Basic Information

Product Name	Eletriptan Impurity 4
CAS No.	1422285-51-5
Molecular Formula	C22H26N2O2S
Molecular Weight	382.52 g/mol
Synonyms	Eletriptan Related Compound 4; (5S)-5-[(Methylsulfonyl)methyl]-2-[2-(1-naphthyl)ethyl]-1H-pyrrole-3-carboxamide; UNII-9K1K3Y3H4P; 9K1K3Y3H4P; Eletriptan Sulfone Impurity; Eletriptan EP Impurity D; Eletriptan USP Impurity D
EINECS	Contact for details

Quality Control

Every batch of Eletriptan Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopoeial standards (USP/EP) and customer specifications. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment and is 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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
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%
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.