Description

Ent-Eletriptan-D3 is a high-purity, deuterium-labeled stereoisomer of the active pharmaceutical ingredient eletriptan, serving as a critical reference standard and internal standard in analytical chemistry. This compound is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods, particularly in pharmacokinetic and metabolism studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities involved in the development and quality control of triptan-class migraine therapeutics.

Application

• Pharmaceutical Reference Standard: Used for the identification, purity assessment, and quantification of eletriptan and its enantiomers in drug substance and finished product testing.
• Bioanalytical Internal Standard: Employed in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of eletriptan in complex biological matrices like plasma, serum, and urine.
• Metabolite Studies: Facilitates the investigation of drug metabolism and pharmacokinetics (DMPK) by tracking the parent drug and its metabolites.
• Method Development & Validation: Critical for developing, optimizing, and validating robust analytical methods in compliance with ICH, FDA, and EMA guidelines.
• Stability-Indicating Assays: Helps in developing assays to monitor the stability and degradation products of eletriptan formulations.
• Impurity Profiling: Aids in the identification and quantification of stereoisomeric impurities during the manufacturing process.

Basic Information

Product Name	Ent-Eletriptan-D3
CAS No.	1217698-26-4
Molecular Formula	C22H23D3N2O2S
Molecular Weight	383.53 g/mol (for deuterated form)
Synonyms	(+)-Eletriptan-D3; (R)-Eletriptan-D3; (3R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole-d3; Eletriptan-d3 Enantiomer; Eletriptan EP Impurity D-D3; UNII-6X1H3095UQ (deuterated form); Relpax-d3 (deuterated analog)
EINECS	Contact for details

Quality Control

Our Ent-Eletriptan-D3 is manufactured under controlled conditions to ensure the highest standards of isotopic purity and chemical integrity. Each batch is subjected to rigorous analytical testing, including NMR (¹H & ²H) for isotopic enrichment confirmation and HPLC/UPLC for chemical and chiral purity. We provide comprehensive Certificates of Analysis (COA) detailing assay, impurity profile, and residual solvent levels, supporting compliance with cGMP and relevant pharmacopeial guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive). The container should be kept in a dry environment and allowed to reach room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Deuterium Enrichment	≥ 98 atom % D
Assay (HPLC)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0% (Ent-Eletriptan-D3)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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