Acetaminophen, also known as Paracetamol, is a widely used pharmaceutical active ingredient belonging to the class of non-opioid analgesic and antipyretic medicines. It is used in pharmaceutical formulations for the temporary relief of mild to moderate pain and reduction of fever.
Acetaminophen is a synthetic organic compound and is commonly supplied as a white or almost white crystalline powder for pharmaceutical manufacturing.
Acetaminophen is widely used as an active pharmaceutical ingredient in:
Acetaminophen provides analgesic and antipyretic effects. It is widely incorporated into pharmaceutical formulations for the management of pain and fever.
Acetaminophen API should be manufactured and tested according to the applicable pharmacopoeial and approved product specifications. Quality controls generally include identification, assay, related substances, loss on drying, residue on ignition, elemental impurities and other applicable pharmaceutical tests.
| Parameter | Specification |
|---|---|
| Appearance | White or almost white crystalline powder |
| Identification | Conforms to identification tests for Acetaminophen |
| Assay (HPLC) | 99.0% – 101.0% on dried basis |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | Complies with applicable elemental impurity requirements |
| pH (1% Solution) | As per applicable pharmacopoeial/approved specification |
| Melting Point | 168°C – 172°C |
| Solubility | Slightly soluble in water; soluble in alcohol |