Doxapram Hydrochloride is a pharmaceutical active ingredient belonging to the respiratory stimulant class. Doxapram acts on peripheral chemoreceptors and central respiratory centers to stimulate respiration and has been used in the management of respiratory depression and selected acute respiratory conditions.
Doxapram Hydrochloride is the hydrochloride salt of Doxapram and is available in pharmaceutical-grade material for use in the development and manufacture of pharmaceutical formulations. The USP monograph specifies Doxapram Hydrochloride as the monohydrochloride monohydrate form.
Doxapram Hydrochloride is a centrally and peripherally acting respiratory stimulant. It increases respiratory drive through stimulation of respiratory control mechanisms and has a relatively short duration of action.
Doxapram is a synthetic small-molecule pharmaceutical compound. The free-base Doxapram has the molecular formula C₂₄H₃₀N₂O₂ and molecular weight 378.51 g/mol.
For pharmaceutical API applications, Doxapram is commonly handled as its hydrochloride salt. Doxapram Hydrochloride monohydrate has the molecular formula C₂₄H₃₀N₂O₂·HCl·H₂O and molecular weight 432.98 g/mol.
Doxapram stimulates respiration primarily through activation of peripheral chemoreceptors in the carotid bodies and, at higher concentrations, through stimulation of central respiratory centers. This increases respiratory drive and can increase tidal volume and respiratory rate.
Doxapram Hydrochloride has been used in pharmaceutical preparations associated with:
Its clinical use and formulation should follow applicable prescribing information and regulatory requirements.
Doxapram Hydrochloride Hydrate occurs as white crystals or crystalline powder. It is freely soluble in methanol and acetic acid, sparingly soluble in water and ethanol, and practically insoluble in diethyl ether according to the Japanese Pharmacopoeia monograph.
Doxapram Hydrochloride API intended for pharmaceutical manufacturing should comply with the applicable pharmacopoeial requirements and validated analytical procedures. The USP monograph includes identification, pH, loss on drying, residue on ignition, heavy metals and chromatographic purity requirements.
Doxapram Hydrochloride is an established pharmaceutical active ingredient used in respiratory-stimulant formulations. Pharmaceutical manufacturers and formulation developers can evaluate Doxapram API based on pharmacopoeial compliance, analytical quality, documentation, regulatory requirements and batch-specific Certificate of Analysis.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 3.5 – 5.0 |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |