Description

Salmeterol-D3 (3-Hydroxymethyl-D2, α-D1) is a deuterium-labeled internal standard of the long-acting β-2 adrenergic receptor agonist salmeterol. This high-purity, isotopically enriched compound is essential for ensuring the accuracy and reliability of quantitative bioanalytical methods. It is primarily used by pharmaceutical R&D and quality control laboratories for pharmacokinetic studies, drug metabolism research, and ensuring regulatory compliance in bioequivalence testing. The product is supplied with a guaranteed Certificate of Analysis detailing isotopic purity and chemical specifications.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the precise quantification of salmeterol in biological matrices like plasma, serum, and urine.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and non-clinical research.
• Drug Metabolism Research: Used in metabolite identification and profiling studies to understand the biotransformation pathways of salmeterol.
• Regulatory Compliance & Bioequivalence Testing: Supports method development and validation for studies required by regulatory agencies (e.g., FDA, EMA) for generic drug approval.
• Forensic and Anti-Doping Analysis: Provides a reliable reference for the detection and confirmation of salmeterol in forensic toxicology and sports doping control.
• Stability-Indicating Assay Development: Aids in developing and validating analytical methods to assess the stability of salmeterol in pharmaceutical formulations.

Basic Information

Product Name	Salmeterol-D3 (3-Hydroxymethyl-D2, α-D1)
CAS No.	497063-94-2
Molecular Formula	C25H34D3NO4
Molecular Weight	419.60 g/mol
Synonyms	Salmeterol-d3; Salmeterol (phenyl-d5); 4-Hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol-d3; 2-(Hydroxymethyl)-4-[1-hydroxy-2-[6-(4-phenylbutoxy)hexylamino]ethyl]phenol-d3; Serevent-d3; GR 33343X-d3; Long-acting β2-adrenoceptor agonist-d3; Deuterated Salmeterol Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Salmeterol-D3 is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity as confirmed by advanced spectroscopic and chromatographic techniques including NMR, HPLC, and LC-MS. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing assay purity, isotopic enrichment, and limits for any potential impurities. Our quality commitment ensures the material meets the stringent requirements for use in regulated bioanalytical laboratories.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (LC-MS)	≥ 99.0 atom % D
Chemical Purity (Titration/NMR)	≥ 95.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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