Regulatory authorities such as International conference of harmonization (ICH), European Directorate for the Quality of Medicines and Healthcare (EDQM), United States Food and Drug Administration (USFDA), and Canadian Drug and Health Agency have been emphasizing the purity requirements and the identification of impurities in Active Pharmaceutical Ingredients (API's). Qualification of the impurities is the process of acquiring and evaluating data that establishes biological safety of an individual impurity; thus, revealing the need and scope of impurity profiling of drugs in pharmaceutical research and manufacturing. Identification of impurities is carried out with various analytical techniques, and where different chromatographic and spectroscopic techniques are common; either alone or in combination with other techniques.In USP and other Pharmacopoeia there are different methods for detecting and characterizing impurities using thin layer chromatography (TLC), high performance thin layer chromatography HPTLC, gas chromatography (GC), high performance liquid chromatography (HPLC), and atomic absorption spectroscopy (AAS) besides more classical tests. There are several reason why HPLC is widely exploited for impurity profiling methods; wide range of detectors available that connect easily with HPLC along with the variety of column chemistries (stationary phases) commercially available.In simple words, with HPLC it is possible to develop robust and reliable methods having necessary sensitivity and linearity that meet requirement in selectivity and provide cost effectiveness to the laboratory.That said, not all methods in current pharmacopoeia are robust and reliable, but they can be changed followed by a submission of the new monograph method to authorities.  In fact, the USP currently requests new monograph proposals under the monograph modernization initiative. It is also possible to make changes of an existing monograph method, and as long as the changes of a monograph method are within defined limits it is possible to carry out only a partial revalidation followed by internal documentation of the updated method.This poster discusses impurity profiling methods, the monograph modernization initiative and how monograph methods can be changed within the defined limits. The examples shown are with different type of molecules; from hydrophobic to very hydrophilic drugs and their impurities. Both reversed phase columns (RP-8, RP-18, and Phenyl chemistries)on either particulate silica particles or monolithic backbones as well as hydrophilic interaction liquid chromatography (HILIC) columns have been used.

Monograph modernization and impurity profiling methods for pharmaceutical drugs per current United States Pharmacopoeia guidelines

248th National Meeting (2014)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.