Author/Editor     Kreft, Katjuša
Title     Bližnja infrardeča spektroskopija v farmacevtski industriji in primerjava s klasičnimi kemijskimi metodami Evropske farmakopeje
Type     članek
Source     In: Rudolf M, editor. Evropska farmakopeja danes in jutri: predstavitev 4. izdaje Ph. Eur. in 3. dopolnila FS. Zbornik ob strokovnem posvetovanju; 2001 nov 29; Ljubljana. Ljubljana: Zavod za farmacijo in za preizkušanje zdravil,
Publication year     2001
Volume     str. 67-72
Language     slo
Abstract     Near Infrared Spectroscopy (NIRS) combined with chemometric data analysis has become a powerful analytical tool. NIBS offers many advantages to pharmacopoeial methods by providing not only chemical but also physical information. This high quality information can be obtained rapidly with little or no sample preparation - in stark contrast to many pharmacopoeial methods. The technique is applicable to both qualitative and quantitative applications and may be used throughout a process from incoming materials (active and excipients), through intermediates to final products. The technique may be applied in a laboratory or process environment, to individual components or to the matrix in its entirety. Europea Pharmacopoeia set the scene for identity testing but providing limited guidance for the user in terms of developing an application (statistical modelling) and its validation.
Descriptors     PHARMACOPOEIAS
CHEMISTRY, ANALYTICAL
DRUG INDUSTRY
EUROPE
SPECTROSCOPY, NEAR-INFRARED