Hyoscine Hydrobromide, also known as Scopolamine Hydrobromide, is an anticholinergic active pharmaceutical ingredient belonging to the tropane alkaloid class. It is the hydrobromide salt of hyoscine and produces antimuscarinic effects by inhibiting acetylcholine activity at muscarinic receptors.
Hyoscine Hydrobromide has the molecular formula C17H21NO4·HBr and a molecular weight of 384.26 g/mol. Its CAS Number is 6533-68-2.
Hyoscine Hydrobromide is a naturally derived tropane alkaloid obtained from plants of the Solanaceae family or produced and purified according to pharmaceutical manufacturing processes. It is formulated as the hydrobromide salt to provide a pharmaceutical form with suitable properties for formulation.
Hyoscine is used for its anticholinergic, antispasmodic and antiemetic properties and has applications in pharmaceutical products targeting motion sickness and gastrointestinal or genitourinary smooth-muscle spasm.
Hyoscine Hydrobromide acts as a competitive antagonist at muscarinic acetylcholine receptors.
By reducing parasympathetic cholinergic activity, it can decrease smooth-muscle contraction and secretory activity. Its effects within the central nervous system also contribute to its antiemetic activity.
Hyoscine Hydrobromide API is used in the development and manufacture of:
Hyoscine Hydrobromide is produced through controlled extraction or synthetic/manufacturing processes, followed by purification, salt formation and pharmaceutical-quality testing.
Quality control may include identification, assay, related substances, optical rotation, water content, residue on ignition and other applicable tests according to the approved specification.
Hyoscine Hydrobromide is generally supplied as a white or almost white crystalline powder. It is readily soluble in water and has the characteristic properties of a hydrobromide salt of the tropane alkaloid hyoscine.
Hyoscine Hydrobromide should be stored in a tightly closed container, protected from excessive moisture, heat and direct light. Storage conditions should follow the manufacturer's current CoA, SDS and validated stability requirements.
Depending on the intended pharmaceutical application, documentation may include:
Hyoscine Hydrobromide is an established antimuscarinic pharmaceutical ingredient with anticholinergic, antispasmodic and antiemetic properties. Its defined chemical profile and pharmaceutical applications make it an important API for motion-sickness, antiemetic and antispasmodic formulations.
| 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% |
| pH (1% Solution) | 4.0 – 6.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 2.0% |
| Specific Rotation | Approximately −18° to −22° |
| Melting Point | Approximately 194–198°C (decomposition) |