Determination of organic impurities in pharmaceutical preparations

Abstract

Data reported in the literature on methods for the determination of organic impurities in pharmaceutical preparations are systematized; the characteristics and possibilities of the methods are compared.

The Role of Analytical Chemistry in the Safety of Drug Therapy

“…This importance can be illustrated by the fact that in the last decade no less than four books have been published dealing solely with impurity and degradant profiling of drugs [187][188][189][190]. In addition to these, book chapters [191][192][193], special issues in journals [194,195], and review papers dealing with general aspects [195][196][197][198][199][200][201], and the application of chromatographic (HPLC, TLC, GC) [194a,b,c,e, 202,203], CE and related electromigration methods [86,[204][205][206][207], hyphenated techniques [107, 118, 133, 134, 141-143, 162, 208-210], and NMR spectroscopy [194f] in drug impurity profiling are worth mentioning.…”

Synthesis and Characterization of Impurities in Rasagiline: A Novel MAO-B Inhibitor in Parkinson’s Disease Therapy

“…Impurities can have a strong antagonistic effect due to unacceptable toxicological and pharmacological action, which can control over the certain effect of the medicine. Also impurities can prevent the effect of the pharmaceutical properties of the drug substance [3].…”

Isolation of oxidative degradation products of atorvastatin with supercritical fluid chromatography

“…The concentration of structurally related compounds (related impurities) in small quantities in the active substance is limited to very low levels by the Pharmacopoeia specifications. They may cause adverse effects owing to their potential pharmacological and toxicological properties and are therefore potentially harmful (Glazkov et al, 2005). Furthermore, the study of the impurity profile and their structure elucidation is of great interest to chemists in developing the synthesis of the active substances.…”

“…When the impurity in the API is present in quite a low concentration, chromatography is applied. The most popular methods are thin-layer and especially preparative high-performance liquid chromatography (HPLC) (Glazkov et al, 2005). In this paper a technique with major potential in the field of isolation of impurities, that is, supercritical fluid chromatography (SFC), was applied.…”