Apomorphine is a potent dopamine receptor agonist derived from morphine by chemical modification. It is used in pharmaceutical formulations for the management of Parkinson's disease, particularly for the treatment of motor fluctuations and sudden “off” episodes in appropriately selected patients.
Apomorphine is chemically classified as an aporphine alkaloid and is supplied in pharmaceutical formulations according to applicable regulatory and quality requirements.
Apomorphine is commonly supplied as apomorphine hydrochloride, including forms such as apomorphine hydrochloride hemihydrate depending on the applicable specification and formulation.
It is used as an active pharmaceutical ingredient in medicines intended for dopaminergic therapy. Product quality should be controlled through validated identification, assay, impurity, residual-solvent, elemental-impurity and other applicable pharmaceutical testing procedures.
Apomorphine is primarily associated with:
Apomorphine intended for pharmaceutical use should be manufactured and tested according to the applicable pharmacopoeial, regulatory and customer specifications.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | Conforms to identification tests for Apomorphine Hydrochloride |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 5.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | Complies with applicable elemental impurity limits |
| pH (1% Solution) | Product-specific specification |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Melting Point | Approximately 220°C (decomp.) |
| Solubility | Soluble in water; solubility depends on salt/form and conditions |