Hyoscine Butylbromide, also known as Scopolamine Butylbromide, is a quaternary ammonium anticholinergic compound used as an antispasmodic pharmaceutical ingredient. It acts primarily on smooth muscle by reducing the effects of acetylcholine at muscarinic receptors.
Because of its quaternary ammonium structure, Hyoscine Butylbromide has limited penetration across the blood-brain barrier compared with tertiary anticholinergic compounds. It is commonly used to relieve acute smooth-muscle spasms and associated cramping in the gastrointestinal and genitourinary systems.
Hyoscine Butylbromide is a specialized pharmaceutical API requiring controlled synthesis, purification and analytical characterization. Quality control generally includes identity, assay, related substances, water content, residual solvents, bromide content and elemental impurities.
The API is used in the development and manufacture of oral and parenteral pharmaceutical formulations.
CAS Number: 149-64-4
Molecular Formula: C21H30BrNO4
Molecular Weight: 440.37 g/mol
Chemical Name: Hyoscine Butylbromide
Synonym: Scopolamine Butylbromide
Drug Class: Anticholinergic
Pharmacological Class: Muscarinic Receptor Antagonist
Therapeutic Class: Antispasmodic
Therapeutic Area: Gastroenterology / Urology
Hyoscine Butylbromide acts as a competitive antagonist at muscarinic acetylcholine receptors. By reducing cholinergic stimulation of smooth muscle, it decreases excessive smooth-muscle contraction and helps relieve spasms.
Its action is particularly relevant to smooth muscle in the gastrointestinal and genitourinary tracts.
Hyoscine Butylbromide is used in pharmaceutical formulations for the symptomatic relief of smooth-muscle spasms associated with:
Specific indications depend on the approved formulation and regulatory labeling.
Hyoscine Butylbromide reduces excessive gastrointestinal smooth-muscle contraction and can therefore be used for the symptomatic treatment of abdominal cramps and spasmodic pain.
The compound is also used in injectable formulations when rapid antispasmodic action is required. Parenteral products require additional pharmaceutical controls appropriate to sterile dosage forms.
Hyoscine Butylbromide is a quaternary ammonium bromide salt and is generally supplied as a white or almost white crystalline powder. Its ionic structure contributes to its water-solubility characteristics and limited central nervous system penetration.
Hyoscine Butylbromide API quality evaluation may include:
For injectable formulations, additional finished-product testing may include sterility, bacterial endotoxins and particulate matter.
Hyoscine Butylbromide should be stored in a tightly closed container, protected from excessive moisture, heat and direct light. Storage conditions should follow validated stability data and the applicable product-specific specification.
Hyoscine Butylbromide remains relevant to pharmaceutical development involving muscarinic receptor antagonism, smooth-muscle relaxation, gastrointestinal antispasmodic therapy and genitourinary spasm management.
Hyoscine Butylbromide is a quaternary ammonium anticholinergic and antispasmodic API with CAS Number 149-64-4, molecular formula C21H30BrNO4, and molecular weight 440.37 g/mol. It reduces muscarinic cholinergic activity in smooth muscle and is used in oral and injectable formulations for symptomatic relief of gastrointestinal and genitourinary spasms.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 4.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 2.0% |