Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 12) doc
Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 12) doc
... specific class for the drug candidate is
critical for future development of dosage forms.
Different platforms are used for solubility measurements: UV; HPLC with
UV detection; or HPLC with MS detection. ... suggests
the necessity to formulate it in the form of salt. The reader is referred to ref-
erence 46 for more information about the properties, selection, and use of salt
forms...
Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 8E) docx
... 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...
Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 8F) docx
... 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...
Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 1) docx
... 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...
Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 3) docx
... 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...
Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 10) doc
... starting conditions for method development by using
information of similar separations
503
HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBrutto
Copyright © 2007 by John ... and
pharmaceutical information provides a basis for a significant increase of devel-
opment efficiency.
If analytical chemists from the various areas of drug development (drug
met...
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...
Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 14) docx
... 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 ... than ELSD [24].
HPLC DETECTORS 655
Electrochemical detection can be utilized for compounds that are ionic or
readily oxidizable or reducible
.Thus, this form of detection can be...
Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 17) doc
... size for use with elevated pressures has therefore been a
necessary and critical advancement for UHPLC [32, 33].The superior loading
capacity of these materials makes them practical for most pharmaceutical
analyses. ... instrumentation are steps toward making UHPLC
a viable tool for pharmaceutical analysis.
Two pressure regimes have been described: very-high pressure LC
(VHPLC),...
Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 22) docx
... 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...