International Conference on Harmonisation; final recommendations on the revision of the permitted daily exposures for two solvents, n-methylpyrrolidone and tetrahydrofuran, according to the maintenance procedures for the guidance Q3C Impurities: Residual Solvents; Availability. Notice.
The Food and Drug Administration (FDA) is announcing final recommendations to revise the permitted daily exposures (PDEs) for two solvents, n-methylpyrrolidone (NMP) and tetrahydrofuran (THF), according to the maintenance procedures for the guidance for industry entitled "Q3C Impurities: Residual Solvents." The final recommendations were reached under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
D002626:Chemistry, Pharmaceutical / Q000592:standards; D003226:Congresses as Topic; D004340:Drug Contamination; D004345:Drug Industry / Q000592:standards; D005060:Europe; D005062:European Union; D005663:Furans / Q000592:standards* / Q000633:toxicity; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation; D007564:Japan; D011760:Pyrrolidinones / Q000592:standards* / Q000633:toxicity; D012997:Solvents / Q000592:standards / Q000633:toxicity; D014481:United States; D014486:United States Food and Drug Administration
D005663:Furans; D011760:Pyrrolidinones; D012997:Solvents