Description

Eletriptan Impurity D is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of eletriptan hydrobromide, a medication used to treat migraines. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and batch release testing. The availability of a well-characterized impurity standard is essential for maintaining stringent quality standards in API production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in eletriptan active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity levels throughout the drug lifecycle.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Quality Control (QC) Testing: Employed in routine QC laboratories to confirm that eletriptan batches meet the specified impurity limits as per pharmacopeial standards (USP, EP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and long-term stability studies.
• Research & Development: Aids in synthetic route optimization and process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Eletriptan Impurity D
CAS No.	1225327-16-1
Molecular Formula	C22H27N3O2S
Molecular Weight	397.54 g/mol
Synonyms	Eletriptan Related Compound D; (5R)-5-[(Methylsulfonyl)methyl]-2-[2-(1-pyrrolidinyl)ethyl]-N-(phenylmethyl)-1H-indole-3-carboxamide; Eletriptan Sulfone Impurity; Eletriptan EP Impurity D; Eletriptan USP Impurity D; Relpax Impurity D; UNII-9F6U8V9A4S (component of); Eletriptan Oxidation Impurity
EINECS	Contact for details

Quality Control

Our Eletriptan Impurity D is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for purity, related substances, and residual solvents, supporting compliance with ICH Q3A, Q3B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
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.