Description

Tiotropium-D5 Bromide is a deuterated isotopologue of the active pharmaceutical ingredient Tiotropium Bromide, specifically labeled with five deuterium atoms. This compound is a critical internal standard used in quantitative analytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and bioanalytical studies. It is essential for research and quality control laboratories in the pharmaceutical industry, particularly those developing or manufacturing long-acting muscarinic antagonist (LAMA) therapies for respiratory conditions like COPD.

Application

• Primary use as an Internal Standard (IS) in Liquid Chromatography-Mass Spectrometry (LC-MS) and LC-MS/MS bioanalysis.
• Quantification of Tiotropium Bromide and its metabolites in pharmacokinetic (PK) and bioequivalence studies.
• Method development and validation for drug substance and drug product analysis in pharmaceutical R&D.
• High-precision quality control testing to ensure batch-to-batch consistency of active pharmaceutical ingredients (APIs).
• Use in clinical research for accurate measurement of drug concentration in biological matrices.
• Supporting regulatory submissions to agencies like the FDA and EMA by providing definitive analytical data.

Basic Information

Product Name	Tiotropium-D5 Bromide
CAS No.	1229646-72-3
Molecular Formula	C19H17D5NO4S2 • Br
Molecular Weight	490.44 g/mol
Synonyms	(1α,2β,4β,5α,7β)-7-[(Hydroxy-di-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane Bromide-d5; Tiotropium-d5; Tiotropium Bromide-d5; 3-[(Hydroxy-di-2-thienylacetyl)oxy]-8,8-dimethyl-8-azoniabicyclo[3.2.1]octane Bromide-d5; Ba 679 BR-d5; Spiriva-d5
EINECS	Contact for details

Quality Control

Our Tiotropium-D5 Bromide is manufactured under strict quality systems to ensure it meets the exacting standards required for analytical reference materials. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), isotopic enrichment, and residual solvents. We support compliance with cGMP and ICH Q7 guidelines for pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after each use to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 98 atom % D
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C limits

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