Pharmaceutical Importance and Significance of Limit Tests

Abstract

The present subject is on the review of various limit test and titrations which are commonly conducted in the Chemistry lab. Limit tests are a category of impurity tests in which a solution of an unknown sample is compared to a standard that contains the impurity at the product limit. Generally this definition applies to limit tests that are in widespread use in various pharmacopoeial compendia, such as United States Pharmacopoeia (USP), European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP) and Food Chemicals Codex (FCC). These tests are used to make a simple pass/fail evaluation of the sample. Typically this category of test relies on the comparison of an unknown sample to a standard solution. Often these tests rely on a visual evaluation by the technician, though some may rely on instrumental analysis of the sample.