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Library | Item Barcode | Call Number | Material Type | Item Category 1 | Status |
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Searching... | 30000005202886 | RS139 Q93 1997 | Open Access Book | Book | Searching... |
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Summary
Summary
Hardbound. It is difficult, if not impossible, to visualize pharmaceutical industry processes without appropriate analytical control, of which chromatographic and, more recently, capillary electromigration techniques constitute a considerable proportion. Problems such as deciding which separation technique will be the best, whether a chromatographic or an electrokinetically driven method is preferred, calibration procedures and method validation, identification of impurities by on-line hyphenation with techniques based on physicochemical principles other than chromatography and electrophoresis and assaying of basic physicochemical properties are all to be solved by the analytical chemist. Unintended errors can occur quite frequently.This volume covers all the above outlined areas, emphasizing those which the authors know from pharmaceutical research to cause problems in practice. The basic guidelines have been summarized along with the necessary theore
Table of Contents
Quality control methods for synthetic drugs |
Comparison of separation and non-separation technologiesX.-Z. Qin |
Considerations for the development of separation methods for pharmaceutical quality controlB.A. Olsen and P.K.S. Tsang |
High performance liquid chromatographic monitoring of process impurities in bulk drugs and formulationsS. Husain and R. Nageswara Rao |
Regression and calibration for analytical separation techniques |
Part I Design considerationsK. Baumann and H. Watzig |
Regression and calibration for analytical separation techniques |
Part II Validation , weighted and robust regressionK. Baumann |
Pharmaceutical applications of liquid chromatography, capillary electrophoresis coupled to mass spectrometryM. Hamdam |
Lipophilicity estimation of drugsG.L. Biagi et al. |
Determination of dissociation constants by separation methods (HPLC and CE) |
Theoretical background and guidelines for applicationM. Uhrovai et al. |
Potential of capillary electrophoresis with micelles or chiral additives as a purity control method in pharmaceutical industryM.-L. Riekkola and S.K. Wiedmer |
Analytical methods for peptide drugs applicable to process controlM. Castagnolai et al. |
Assessment of protein drugs obtained by recombinant DNA technologyR.E. Kaiser et al. |
Ion-pairing procedures applicable to drug quality controlA.K. Dash |