ISBN-13: 9783659265839 / Angielski / Miękka / 2012 / 160 str.
Objective of the study is for the detection and quantification of impurities and related substances in the manufacturing batch of statins and to ensure regulatory compliance. Bulk drug during its production process, after its scale up, it is necessary to analyse for the presence of any impurities or related substances in it. This is to ensure the impurities and related substances are within their limits.