Description

Eletriptan Hydrobromide Monohydrate is the hydrobromide salt monohydrate form of a selective serotonin receptor agonist. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of finished pharmaceutical products. It is primarily required by pharmaceutical manufacturers and research institutions for the development and production of migraine-specific therapeutics.

Application

• Pharmaceutical API: Primary use as the active ingredient in the formulation of anti-migraine medications.
• Reference Standard: Serves as a certified reference material (CRM) for quality control and analytical method development in laboratories.
• Drug Product Development: Used in R&D for formulating tablets, orally disintegrating tablets, and other solid dosage forms.
• Clinical Trial Material: Manufactured under GMP conditions for use in Phase I-III clinical studies.
• Generic Drug Manufacturing: A key component for companies producing bioequivalent generic versions of branded migraine treatments.
• Pharmacological Research: Utilized in preclinical and clinical studies to investigate serotonin receptor mechanisms.

Basic Information

Product Name	Eletriptan Hydrobromide Monohydrate
CAS No.	273211-28-2
Molecular Formula	C22H27N2O2S • HBr • H2O
Molecular Weight	479.44 g/mol
Synonyms	Eletriptan HBr Monohydrate; (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole Hydrobromide Monohydrate; UK-116,044-26; Relpax (Trade Name) API; 1H-Indole, 3-[(1-methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-, hydrobromide, monohydrate, (R)-; Eletriptan Hydrobromide Hydrate
EINECS	Contact for details

Quality Control

Our Eletriptan Hydrobromide Monohydrate is manufactured and tested to meet stringent pharmacopeial standards, including ICH Q7 guidelines for active pharmaceutical ingredients. Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We ensure compliance with relevant regulatory requirements for pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.5% - 101.5% (on anhydrous basis)
Water Content (KF)	3.0% - 4.5%
Related Substances (HPLC)	Individual impurity ≤ 0.15%; Total impurities ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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