Abstract

ORGANIC VOLATILE IMPURITIES AND THEIR REGULATORY LIMITS: A PHARMACEUTICL PERSPECTIVE

Author(s): VISHAL RUPAPARA1*, JITENDRA PATEL2, VIVEK CHAVDA3*, MOINUDDIN SONIWALA

mpurities  in  drug  substances  and  drug  products  have  been  important  regulatory  issues  in  the  Office  of  Generic  Drugs  by  having  significant  impact  on  the  approvability  of Abbreviated  New  Drug  Application  (ANDAs).Organic  solvents  are  commonly  used  in  the  pharmaceutical  industry  as  reaction  media,  in  separation  and  purification  of synthesis products and also for cleaning of equipments. As residual solvents are not desirable substances in a final product,different methods for their removal may be used, provided they fulfill safety criteria. After the drying process, analysis need to be performed to check if amounts of solvents used at any step of the production do not exceed acceptable limits (taken from ICH Guideline or from pharmacopoeias). Also new solvents like supercritical fluids or ionic liquids are developed to replace traditionalorganic solvents in the pharmaceutical production processes. This review was grafted to provide information regarding OVI and/or residual solvent

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