Doxylamine Succinate is a pharmaceutical active pharmaceutical ingredient (API) belonging to the ethanolamine class of antihistamines. It is primarily used for its antihistaminic and sedative properties and is used in pharmaceutical formulations for temporary relief of insomnia and, in combination with other ingredients, for selected cold and allergy symptoms.
Doxylamine Succinate is the succinate salt of doxylamine, a first-generation antihistamine. It produces antihistaminic effects primarily through antagonism of histamine H1 receptors. Because it readily crosses the blood-brain barrier, it can also produce significant sedative effects.
Doxylamine Succinate is a synthetic small-molecule API supplied for pharmaceutical formulation development and manufacturing. It is commonly incorporated into oral pharmaceutical products such as tablets, capsules and combination formulations.
Doxylamine acts primarily as an H1 histamine receptor antagonist. Blocking histamine-mediated signaling reduces allergic symptoms, while its central nervous system activity contributes to its sedative properties.
Doxylamine Succinate is used in pharmaceutical formulations for:
The exact indications depend on the finished formulation and applicable regulatory approval.
Doxylamine Succinate is generally described as a white crystalline powder. It is soluble in water and alcohol and is supplied as a pharmaceutical-grade material for formulation applications.
Doxylamine Succinate API intended for pharmaceutical manufacturing should be manufactured and tested according to applicable GMP and pharmacopoeial requirements. Quality evaluation may include identity, assay, related substances, water content, residual solvents, elemental impurities and other applicable quality attributes.
Doxylamine Succinate is an established pharmaceutical antihistamine API used in the manufacture of various oral pharmaceutical formulations. Pharmaceutical manufacturers and formulation developers can evaluate the API based on applicable pharmacopoeial standards, 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 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.5 – 6.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | Approximately 102°C – 108°C |