Practical difficulties in meeting the residual solvents level
Greener ways of the preparation of some common chemicals
Solvent free reactions
PMI ( Process mass Intensity )
List of class II solvents The Solvent levels should to be screened through the chromatographic method & Quantified in the Final API
Genotoxic carcinogens Carcinogens which are produces cancer by the affecting the genes are or chromosomes Nurotoxicity The ability of a substance to cause adverse effect on the nervous system PDE: Abbreviation for permitted daily exposure
LIST OF CLASS III SOLVENTS Since the solvents are class-III the accepted limit is LOD NMT 0.5% in Final API .No need of the chromatographic method or Quantification.
Class II solvent for which no toxicological data available . Due to the non availability of the toxicological data the manufacturer should give the Justification for the usage & the residual solvent levels of the above solvents in the final API.