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Ipratropium bromide
1. Basic Information
Name: Ipratropium bromide
Alias: (8r)-3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane bromide
CAS No.: 22254-24-6
Molecular Formula: C20H30Br1NO3
Molecular Weight: 412.36
Category: Quaternary ammonium anticholinergic API, respiratory inhalation therapeutic raw material
2. Physical and Chemical Properties
Physical Properties
- Appearance: White crystalline powder
- Odor: Odorless
- Solubility: Freely soluble in water, methanol; soluble in ethanol; slightly soluble in acetone; insoluble in ether, alkanes
- Melting Range: 230–232 ℃ (decomposes)
- Hygroscopy: Slightly hygroscopic in high humidity
- Aqueous property: Aqueous solution weakly acidic, stable under neutral & weak acidic conditions
Chemical Properties
- Molecular structure: Tropane quaternary ammonium bromide salt, contains ester group, tertiary aromatic hydroxyl, chiral bicyclic skeleton
- Ester hydrolysis: Ester linkage breaks under strong acid/alkali heating to generate tropine and phenylpropionic acid impurities
- Quaternary ammonium characteristic: Stable cation structure, not easy to pass through blood-brain barrier, low central side effects
- Optical activity: Contains multiple chiral centers, strict optical purity requirements for pharmaceutical grade
- Thermal stability: Stable below 210 ℃; high temperature decomposes and releases bromide-containing volatile substances
- Photostability: Light-sensitive; long-term UV irradiation produces yellow degradation impurities
- Compatibility: Compatible with water, low-carbon alcohols; incompatible with strong oxidants, concentrated strong base
3. Main Application Fields
1. Respiratory Inhalation API (Core Application)
Anticholinergic drug for asthma, chronic obstructive pulmonary disease (COPD); relax bronchial smooth muscle to relieve dyspnea, commonly made into aerosol, nebulizer solution
2. Pharmacopoeia Reference Standard
HPLC standard for related substances detection in ipratropium bromide production QC
3. Pharmacological Research Reagent
Laboratory tool for muscarinic acetylcholine receptor antagonism mechanism research
4. Quality Specification Table
| Test Item | Standard Specification |
| CAS Number | 22254-24-6 |
| Molecular Formula | C20H30Br1NO3 |
| Appearance | Uniform white crystal without discoloration impurities |
| HPLC Purity | Pharma Grade ≥99.0% |
| Specific Optical Rotation [α]D20 | ?10° ~ ?14° (water) |
| Water Content (KF) | ≤0.30% |
| Residue on Ignition | ≤0.10% |
| Single Maximum Unknown Impurity | ≤0.05% |
| Heavy Metals (Pb) | ≤10 ppm |
| Packaging | Nitrogen-filled amber vacuum aluminum foil bags / PE lined fiber drums |
| Storage Condition | Hermetically sealed cool dry warehouse below 25 ℃, full light shielding, isolate moisture & alkaline materials |
| Transportation Requirement | Light-sensitive quaternary ammonium salt solid, moisture-proof light-proof sealed packaging |
| Shelf Life | 24 months under nitrogen vacuum sealed storage |
Safety Warning
Low acute toxicity irritant pharmaceutical powder. Dust irritates eyes, nasal tract and respiratory mucosa; long-term skin contact may cause mild dry allergic reaction. All operations must be carried out in ventilated fume hood with dust-proof respirator and nitrile gloves. Prescription drug, improper oral use may cause dry mouth, tachycardia, urinary retention and other anticholinergic side effects. Waste liquid neutralized before discharge; solid waste classified as halogen-containing pharmaceutical hazardous waste disposed by licensed professional institutions.
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