Product Name: | Phe-nacetin |
Synonyms: | ACETOPHENETIDI;ACETOPHENETIDI;ACET-P-PHENETIDIN;ACETYL-P-PHENETIDIN;1-ACETYL-P-PHENETIDIN;4-ACETOPHENETIDIDE;4-acetophenetidi;4′-ETHOXYACETANILIDE |
CAS: | 62 CAS 44 2 |
MF: | C10H13NO2 |
MW: | 179.22 |
EINECS: | 200-533-0 |
Product Categories: | Others;Amines;Aromatics;Intermediates & Fine Chemicals;Pharmaceuticals;organic interme;Organics;Other APIs;API |
Phe-nacetin, a painkiller, was the world's first synthetic pharmaceutical drug. It was one of the first painkillers that was not derived from opiu while at the same time being absent of antiinflammatory qualities. Phe-nacetin was developed in 1878 by an American chemist, Harmon Northrop Morse. It was introduced into the pharmaceutical market in 1887. However, it was withdrawn in 1983 in the United States due to unacceptable levels of interstitial nephritis in patients and potential risks of tumorigenicity. Like in the United States, most Western countries did not ban phe-nacetin from marketing until 1983. Phe-nacetin is a component of APC (aspirin-phe-nacetin-caffe).
Phe-nacetin was widely used until the third quarter of the twentieth century, often in the form of an "A.P.C." or aspirin-phe-nacetin-caffei compound analgesic, as a remedy for fever and pain. An early formulation (1919) was Vincent's APC in Australia. However the U.S. Food and Drug Administration ordered the withdrawal of drugs containing phe-nacetin in November 1983, owing to its carcinogenic and kidney-damaging properties (Federal Register of October 5, 1983 (48 FR 45466)). It was also banned in India.As a result, some branded, previously phe-nacetin-based preparations continued to be sold, but with the phe-nacetin replaced by safer alternatives. A popular brand of phe-nacetin was Roche's Saridon, which was reformulated in 1983 to contain propyphenazone, paracetamol and caffei. Coricidin was also reformulated without phe-nacetin. Paracetamol is a metabolite of phe-nacetin with similar analgesic and antipyretic effects, but the new formulation has not been found to have phe-nacetin's carcinogenicity.
Items of analysis | Specification | Results | |
Description | Should comply with the standard | Conforms | |
Identification | positive | positive | |
Melting point | 134ºC to 136.5ºC | 134.5-136.5ºC | |
4-chloroacetanilide | BP68 | <3.5ml/0.6g | |
P-Phenetidin | BP68 | Conforms | |
Sulphated ash | ≤0.1% | 0.08% | |
Assay | ≥99% | 99.2% | |
Conclusion | Qualified |