Description

Tiotropium Bromide Hydrate is a long-acting muscarinic antagonist (LAMA) used as the active pharmaceutical ingredient (API) in inhalation therapies. This compound is critical for the formulation of maintenance treatments for chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Pharmaceutical manufacturers and advanced research institutions require this high-purity API to develop and produce reliable, effective dry powder inhalers (DPIs) and other respiratory medications.

Application

• Active Pharmaceutical Ingredient (API) for inhalation therapies targeting Chronic Obstructive Pulmonary Disease (COPD).
• Formulation of Dry Powder Inhalers (DPIs), such as in the production of branded and generic respiratory medications.
• Research and Development of new long-acting bronchodilators and combination therapies for respiratory conditions.
• Pharmaceutical Reference Standard for quality control and analytical method development in regulatory testing.
• Clinical Trial Material for studies investigating new treatments for asthma and other obstructive airway diseases.

Basic Information

Product Name	Tiotropium Bromide Hydrate
CAS No.	139404-48-1
Molecular Formula	C19H22BrNO4S2 · xH2O
Molecular Weight	472.42 g/mol (anhydrous basis)
Synonyms	BA 679 BR; Tiotropium Bromide Monohydrate; (1α,2β,4β,5α,7β)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane Bromide Monohydrate; Spiriva API; Ba 679; Tiotropium Bromide Hydrate (JP17); UNII-3QQT10B9C5
EINECS	Contact for details

Quality Control

Our Tiotropium Bromide Hydrate is manufactured under strict quality management systems. It is typically supplied to meet pharmaceutical-grade specifications, with purity often exceeding 99.0% (by HPLC). Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing identity, purity, related substances, residual solvents, and other critical parameters. We ensure compliance with ICH Q7 guidelines and relevant pharmacopeial standards (e.g., USP, EP, JP).

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 dry, inert conditions to maintain stability and potency.

Specification

Item	Specification
Appearance	White to almost white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water Content (KF)	2.0% - 5.0%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	NMT 20 ppm
Sulfated Ash	NMT 0.1%

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