Clidinium Bromide is an anticholinergic active pharmaceutical ingredient that reduces gastrointestinal smooth-muscle spasms and secretions by blocking muscarinic acetylcholine receptors. It is used in pharmaceutical formulations for gastrointestinal disorders associated with smooth-muscle spasm.
Clidinium Bromide is chemically identified as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydiphenylacetyl)oxy]-1-methyl-, bromide, (±)-. The compound has the molecular formula C₂₂H₂₆BrNO₃ and molecular weight 432.36 g/mol.
FDA's substance record confirms Clidinium Bromide as the bromide salt and identifies the active moiety as clidinium.
| Field | Value |
|---|---|
| Product Name | Clidinium Bromide |
| CAS Number | 3485-62-9 |
| Alternate CAS / CAS 2 | None |
| Grade | API / Pharmaceutical Grade |
| Category | Active Pharmaceutical Ingredient |
| Appearance | White to almost-white crystalline solid/powder |
| Molecular Formula | C₂₂H₂₆BrNO₃ |
| Molecular Weight | 432.36 g/mol |
| Chemical Class | Quaternary ammonium anticholinergic |
| Therapeutic Class | Anticholinergic |
| Pharmacological Class | Muscarinic receptor antagonist |
| Stereochemistry | Racemic / mixed |
| Optical Activity | ± |
| Standards Compliance | USP-NF |
The USP-NF 2026 monograph confirms the current assay definition and molecular identity.
1-Azoniabicyclo[2.2.2]octane, 3-[(hydroxydiphenylacetyl)oxy]-1-methyl-, bromide, (±)-
| Parameter | Specification |
|---|---|
| Identification | IR absorption; HPLC retention-time agreement; Bromide test positive |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |
| Melting Point | 184–189°C for the picrate derivative |