Description

Tiotropium-D3 Bromide is a deuterated isotopologue of the established anticholinergic agent Tiotropium Bromide, specifically labeled with three deuterium atoms. This compound serves as a critical internal standard in quantitative bioanalytical methods, ensuring high accuracy and reliability in pharmacokinetic and metabolic studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers involved in the development and quality control of respiratory therapeutics.

Application

• Internal Standard for LC-MS/MS: Essential for the precise quantification of Tiotropium and its metabolites in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic (PK) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Metabolite Profiling: Used as a reference standard to identify and quantify deuterated and non-deuterated metabolite fractions.
• Method Development and Validation: Critical for establishing robust, regulatory-compliant (FDA, EMA) bioanalytical assays.
• Quality Control in Manufacturing: Supports impurity profiling and assay verification for active pharmaceutical ingredient (API) batches.
• Stability-Indicating Assays: Aids in studies determining the degradation pathways and shelf-life of pharmaceutical formulations.

Basic Information

Product Name	Tiotropium-D3 Bromide
CAS No.	1127226-56-5
Molecular Formula	C19H19D3NO4S2•Br
Molecular Weight	490.44 g/mol
Synonyms	(1α,2β,4β,5α,7β)-7-[(Hydroxy-di-deuteromethoxy)di-deuteromethyl]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane Bromide; Tiotropium Bromide-d3; Tiotropium-d3 Bromide; (8R)-6β,7β-Epoxy-8-ethyl-3α-[(di-deuteromethoxy)(deuteromethyl)thio]-1αH,5αH-tropanium Bromide; Spiriva-d3 Internal Standard
EINECS	Contact for details

Quality Control

Every batch of Tiotropium-D3 Bromide is manufactured and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) detailing purity (by HPLC), isotopic enrichment, and identity confirmation (by NMR and MS). Our quality protocols are designed to meet the stringent requirements for reference standards used in GLP and GMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant and inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 98 atom % D
Chemical Purity (Titration)	≥ 97.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 1.0%

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