Description

Ipratropium Bromide Monohydrate CAS NO 66985-17-9 is a quaternary ammonium anticholinergic agent, recognized for its bronchodilator properties. It is a critical active pharmaceutical ingredient (API) used in the formulation of inhalation medications for the management of chronic obstructive pulmonary disease (COPD) and asthma. This high-purity compound is essential for pharmaceutical manufacturers and research institutions developing respiratory therapies, where consistent quality and reliable supply are paramount.

Application

• Primary Active Pharmaceutical Ingredient (API) in metered-dose inhalers (MDIs) and nebulizer solutions for bronchospasm associated with COPD and asthma.
• Key component in combination inhalation therapies, often formulated with β-2 agonists like salbutamol.
• Used in pharmaceutical research and development for studying anticholinergic mechanisms and developing new respiratory drug formulations.
• Reference standard in analytical laboratories for quality control and method validation of inhalation products.
• Starting material for the synthesis of related quaternary ammonium compounds in medicinal chemistry.

Basic Information

Product Name	Ipratropium Bromide Monohydrate
CAS No.	66985-17-9
Molecular Formula	C20H30BrNO3 • H2O
Molecular Weight	430.37 g/mol (monohydrate)
Synonyms	8-Azoniabicyclo[3.2.1]octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate, (1R,3r,5S)-; Ipratropium Bromide Hydrate; Atrovent (brand name derivative); Ba 253 BR; Sch 1000; (1R,5S)-3-[(2S)-3-Hydroxy-2-phenylpropanoyl]oxy-8-methyl-8-propan-2-yl-8-azoniabicyclo[3.2.1]octane bromide monohydrate
EINECS	Contact for details

Quality Control

Our Ipratropium Bromide Monohydrate is manufactured under strict quality management systems. It is produced to meet exacting standards suitable for pharmaceutical applications, with comprehensive testing to ensure identity, purity, and potency. A detailed Certificate of Analysis (COA) is provided with each batch, confirming compliance with specifications for assay, related substances, residual solvents, and water content. We support compliance with major pharmacopoeial standards (USP/EP) and cGMP guidelines.

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 in a dry environment to prevent degradation. The original container should be kept sealed when not in use.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	3.5% - 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.