Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 13) docx

... or microorganisms to screen their spectrum of 605 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBrutto Copyright © 2007 by John Wiley & Sons, Inc. baseline setup, ... treated as a whole (for more details see www.fda.gov; General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002). The PQ is usually perf...

Ngày tải lên: 22/01/2014, 00:20

... that was optimized by Drylab, a forced degrada- tion sample was run that was stressed at 50°C for 1 week in pH 1 diluent. It was noted that a major impurity was formed (Figure 8-49) and was determined to ... isocratic conditions for deter- mining the most suitable pH for the method. The retention behavior of active as a function of pH (isocratic) was determined. The best mobile-phase pH...

Ngày tải lên: 15/12/2013, 12:15

... crystals that will damage the seal over time. Therefore it is recommended to wash the HPLC system with acetonitrile/water (20:80) for at least 30min before the system is shut down to remove any potential ... of analysis is critical to the success for fast and effective method development. The general approach for the method development for the separation of pharmaceutical compound...

Ngày tải lên: 24/12/2013, 18:15

... are three basic types of molecular forces: ionic forces, polar forces, and dispersive forces. Each specific technique capitalizes on each of these specific forces: 1. Polar forces are the dominant type ... employed in normal-phase HPLC (see Chapter 5). 2. Dispersive forces are employed in reversed-phase HPLC (see Chapter 4). 3. Ionic forces are employed in ion-exchange HPLC (see Chapter...

Ngày tải lên: 24/12/2013, 18:15

... in HPLC are porous particles with average diameters between 3 and 10µm. For most pharmaceutical applications, 3-µm particle sizes are recommended. Porosity provides the surface area necessary for ... (version 9.3). b Ligand length calculated using ACD software for the distance between anchoring oxygen and foremost atom in all-trans conformation of corresponding ligand. 3.6.2.1 Types...

Ngày tải lên: 24/12/2013, 18:15

... is highly unlikely that the synthetic process 641 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBrutto Copyright © 2007 by John Wiley & Sons, Inc. of blanks injected ... products were formed (Figure 14 -13). The formation of these additional degradation ESTABLISHMENT OF HPLC SELECTIVITY BY STRESS STUDIES 667 Figure 14-11. w w pH study on Luna C18...

Ngày tải lên: 22/01/2014, 00:20

... the two sets of crystals, the molecules are 987 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBrutto Copyright © 2007 by John Wiley & Sons, Inc. mobile phases ... conformation with the N-TFA-α-amino acid isopropyl ester. (Reprinted from reference 36, with permission.) The introduction of the diamide derivatives for enantiomeric separation was a ste...

Ngày tải lên: 26/01/2014, 19:20

... ions on the basis of mass-to-charge ratios, 281 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBrutto Copyright © 2007 by John Wiley & Sons, Inc. low-polarity ... the most widely used systems for analysis of large bio- molecules. For a continuous ion source, the ions can be stored for a short period of time and pulsed out for analysis. In the...

Ngày tải lên: 15/12/2013, 12:15

... metabolites are important biotransformation pathways for many drugs and xenobiotics [127, 132, 133]. For example, the formation of acyl glucuronide conjugate forced the withdrawal of four marketed ... intermediates for formation of the keto acid, were also observed in the radiochromatogram of rat plasma (spectrum not shown) [131]. PRACTICAL APPLICATIONS 335 Scheme 11. Mechanism for th...

Ngày tải lên: 15/12/2013, 12:15

... development; these include speed 347 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBrutto Copyright © 2007 by John Wiley & Sons, Inc. for these studies. Fast gradient ... the ACD prediction of the solubil- ity for the ionized form of bases and acids shows greater deviation than for the solubility predicted for the neutral form of the molecule...

Ngày tải lên: 15/12/2013, 12:15