Guaifenesin is an expectorant active pharmaceutical ingredient used to help loosen and thin mucus in the respiratory tract, making it easier to clear mucus through coughing. It is a well-established pharmaceutical ingredient used in oral cough and cold formulations.
Guaifenesin is chemically known as 3-(2-methoxyphenoxy)-1,2-propanediol. It has the molecular formula C₁₀H₁₄O₄ and a molecular weight of 198.22 g/mol. Its CAS Number is 93-14-1.
Guaifenesin is a synthetic, non-opioid expectorant. It is commonly incorporated into pharmaceutical formulations designed for the symptomatic relief of cough associated with respiratory conditions involving excessive or thick mucus.
The compound contains a guaiacol-derived aromatic ether structure together with a glycerol side chain. Its chemical structure contributes to its physicochemical characteristics and suitability for oral pharmaceutical formulations.
Guaifenesin acts as an expectorant. It increases the volume and reduces the viscosity of respiratory secretions, helping facilitate the clearance of mucus from the airways.
By making bronchial secretions less viscous and easier to mobilize, guaifenesin can assist productive coughing and mucus clearance.
Guaifenesin API is used in the development and manufacture of:
Guaifenesin is a synthetic pharmaceutical ingredient manufactured through controlled chemical processes followed by purification, drying and quality-control testing.
Routine quality evaluation may include identification, assay, related substances, loss on drying, residue on ignition, elemental impurities and other applicable pharmaceutical-quality parameters.
Guaifenesin is generally described as a white or almost white crystalline powder or crystals. It is freely soluble in water and soluble in alcohol.
Guaifenesin should be stored in a tightly closed container, protected from excessive heat, moisture and direct light, under the storage conditions specified by the applicable manufacturer or pharmacopoeial specification.
Depending on the material and applicable regulatory requirements, documentation may include:
Guaifenesin is an established pharmaceutical expectorant API with broad use in oral respiratory formulations. Its defined chemical identity, established pharmacological application and suitability for various dosage forms make it an important ingredient for cough and cold pharmaceutical products.
| 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% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |
| Melting Point | 78–82°C |