Impurity profiling emerging trends in quality control of pharmaceuticals

Poonam P. Patil, Veena S. Kasture, Vanitha Prakash K.

Abstract


Impurities are nothing but the unidentified, unintended substance present along with desired substance. The newer regulations of US FDA, MHRA intends for the requirements of impurities rather than purity of pharmaceuticals. The impurity profiling of pharmaceuticals can be done by using various analytical methods like UV, HPLC, LC-MS, GC-MS, SCFC etc. Mostly RP-HPLC method commonly adopted for the qualification as well as quantification of impurities. The present review is an attempt made in the respect of highlighting the some important methods, quality guidelines and applications of impurity profiling.


Keywords


Impurity, quality control, pharmaceuticals, impurity fate mapping, analytical techniques

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DOI: http://dx.doi.org/10.7439/ijpc.v5i1.1539

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