Description

Ipratropium Bromide is a quaternary ammonium anticholinergic agent, recognized for its potent bronchodilatory effects. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of respiratory medications. It is primarily required by pharmaceutical manufacturers developing inhalation therapies for chronic obstructive pulmonary disease (COPD) and asthma management.

Application

• Primary Pharmaceutical Ingredient: Core active component in metered-dose inhalers (MDIs), nebulizer solutions, and dry powder inhalers (DPIs) for the treatment of bronchospasm.
• COPD Management: Formulated into maintenance medications for chronic obstructive pulmonary disease, including emphysema and chronic bronchitis.
• Asthma Therapy: Used in combination bronchodilator formulations (e.g., with albuterol/salbutamol) for the relief of acute asthma symptoms.
• Generic Drug Production: Sourced by generic pharmaceutical companies for the manufacture of bioequivalent respiratory products.
• Clinical Research: Serves as a reference standard and raw material in preclinical and clinical studies for new respiratory drug delivery systems.
• Veterinary Pharmaceuticals: Potential application in veterinary medicine for treating respiratory conditions in animals.

Basic Information

Product Name	Ipratropium Bromide
CAS No.	2784-21-6
Molecular Formula	C20H30BrNO3
Molecular Weight	412.37 g/mol
Synonyms	8-Azoniabicyclo[3.2.1]octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, (1R,3r,5S)-; Atrovent; Ipratropium; Sch 1000; (1R,5S)-3-[(2S)-3-Hydroxy-2-phenylpropanoyl]oxy-8-methyl-8-propan-2-yl-8-azoniabicyclo[3.2.1]octane bromide; Ipratropii Bromidum
EINECS	220-500-6

Quality Control

Our Ipratropium Bromide is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Every batch undergoes comprehensive analytical testing including identification, assay, impurity profiling, and residual solvent analysis to ensure it meets stringent pharmaceutical-grade specifications. A Certificate of Analysis (COA) documenting all test results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which can affect stability and handling properties.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5%; Total impurities: ≤ 2.0%
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.