Research analytical documentation

Recently ECL reactions of Ru(bpy)32+ with other reducing agents have been documented, such as various P-diketone and some methylene compounds that have cyano and carbonyl groups [40], Hence with further research, analytical applications should arise for many classes of compounds other than amines that can act as reductants, or electrochemical precursors of reductants, capable of reacting with Ru(bpy)33+ to produce ECL. 

AUSM - Analytical Documentation," Volumes I, II, and III. Assembled by U.S. Environmental Protection Agency, Industrial and Environmental Research Laboratory, prepared by Universities Research Group on Energy. March 1983. 

Thanks to the efforts of a continuously increasing number of research groups, CE has by now been accepted as a highly efficient separation technique for qualitative purposes, with about 1500 CE-related documents appearing annually in analytical journals. However, CE has not yet been fully established as a quantification method, mainly due to the predominance of HPLC techniques applied in standard, validated analytical protocols. 

SP refers to a family of solid/liquid handling techniques to extract or to enrich analytes from sample matrices into an analyzable format, namely, the final analyte solution. While SP techniques are well documented, " few publications address the specific requirements for drug product preparations, most of which tend to employ the simple dilute and shoot approach. A more elaborate SP is often needed for complex sample matrices (e.g., lotions and creams). Many newer SP technologies such as solid-phase extraction (SPE), " supercritical fluid extraction (SFE), "i° pressurized fluid extraction or accelerated solvent extraction (ASE)ii"i and robotics " " are topics of numerous research papers, symposia and commercial promotion. However, for reasons discussed later, these newer developments have had little impact on the way pharmaceutical laboratories conduct their SP for drug products today. 

Guidance for Industry, Analytical Procedures and Method Validation Chemistry, Manufacturing and Controls Documentation, Draft, August 2000, Center for Drug Evaluation and Research, Center for Biologies Evaluation and Research, FDA, Department of Health and Human Services, 2000. 

During the 1990 Washington Conference on Analytical Methods Validation Bioavailability, Bioequivalence and Pharmacokinetic Studies [1], parameters that should be used for method validation were defined. The final report of this conference is considered the most comprehensive document on the validation of bioanalytical methods. Many multinational pharmaceutical companies and contract research organizations contributed to its final draft. This scientific meeting was sponsored by the American Association of Pharmaceutical Scientists (AAPS), the Association of Official Analytical Chemists (AOAC), and the U.S. Food and Drug Administration (FDA). The conference report has been used as a reference by bioanalytical laboratories and regulatory agencies worldwide. 

Recently, the topic of method development for both routine and non-routine analyses has been the subject of two EURACHEM documents The Fitness for Purpose of Analytical Methods and Quality Assurance for Research and Development and Non-routine Analysis as part of the VAM (Valid Analytical Measurements) programme. These guides provide information and a bibliography for ISO publications. 

All stability studies on clinical trial materials must be carried out in full accordance with cGMPs, even if a research department carries out the studies. All studies must be carried out by adequately trained personnel under adequate work conditions. The personnel must use properly qualified and calibrated stability chambers, instruments, reagents, and standards. They must follow validated analytical methods and approved written procedures, and they must properly document all work. There must be proper sample and data traceability, change control, and go on. 

As detailed previously, so far QDs have been bioconjugated to different antibodies in an assortment of fluoroimmunoassays aiming at selective detection of proteins and small molecules. Such studies have documented that QDs may be used as generalized reporters in immunoassays. More recently some researchers have started to investigate alternative analyte receptors to be conjugated to such reporter QDs. 

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