Description

Tiotropium Bromide Hydrate is a long-acting anticholinergic bronchodilator, chemically classified as a quaternary ammonium salt. This high-purity active pharmaceutical ingredient (API) is critical for the formulation of reliable and effective inhalation therapies for chronic respiratory conditions. It is primarily required by pharmaceutical manufacturers and research institutions developing treatments for chronic obstructive pulmonary disease (COPD) and asthma.

Application

• Pharmaceutical API: Primary active ingredient in dry powder inhalers (DPIs) and other inhalation formulations for the maintenance treatment of COPD and asthma.
• Respiratory Drug Development: Key compound in R&D for novel long-acting muscarinic antagonist (LAMA) therapies and combination products.
• Reference Standard: Used as a certified reference material (CRM) in analytical laboratories for method development, validation, and quality control testing.
• Clinical Research: Serves as the benchmark material in bioequivalence and pharmacokinetic studies for generic drug applications.
• Formulation Studies: Employed in pre-formulation and stability studies to develop optimized drug delivery systems.

Basic Information

Product Name	Tiotropium Bromide Hydrate
CAS No.	411207-31-3
Molecular Formula	C19H22BrNO4S2 • xH2O
Molecular Weight	472.42 (Anhydrous)
Synonyms	Tiotropium Bromide Monohydrate; (1α,2β,4β,5α,7β)-7-[(Hydroxidi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane Bromide Hydrate; Ba 679 BR; Spiriva® (Brand Name API); Ba-679-BR
EINECS	Contact for details

Quality Control

Our Tiotropium Bromide Hydrate is manufactured under strict quality management systems. Each batch is tested to meet stringent specifications for identity, purity, and potency, aligning with ICH guidelines and current pharmacopoeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) detailing all test results, including assay, related substances, residual solvents, and water content, is provided with every shipment to ensure full traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under conditions that minimize exposure to atmospheric humidity to maintain stability and potency.

Specification

Item	Specification
Appearance	White to almost white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	2.0% - 5.0%
Related Substances (HPLC)	Individual impurity: ≤0.5%; Total impurities: ≤2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤20 ppm
Sulfated Ash	≤0.1%

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