Pharmaceuticals analytical aspects

Hassan et al [65] used a method for the determination of primaquine and other antimalarials, through ternary complex formation. The analytical aspects of the reaction between the widely used antimalarial drugs with cobalt and thiocyanate to form ternary complexes are described. Alternatively, determination of the cobalt content of the nitrobenzene extract using atomic absorption spectroscopy provided an indirect method for the determination of the drugs. Both methods are applied to the analysis of pharmaceutical preparation and the results obtained agreed well with those obtained with official methods. 

Gottardi W (1999) Iodine and disinfection theoretical study on mode of action, efficiency, stability and analytical aspects in the aqueous system. Arch Pharm Pharmaceut Med Chem 332 151-157 Halliwell B, Gutteridge JM (1999) Free radicals in biology and medicine. Oxford University Press, Oxford, UK... 

Volpi, N. (2007). Analytical aspects of pharmaceutical grade chondroitin sulfates. J. Pharm. Sci. 96, 3168-3180. 

The importance of isothiazole and of compounds which contain the isothiazole nucleus appears to be growing over the years. New synthetic approaches and unprecedented reactions have been reported and numerous technical and pharmaceutical applications have been discovered. This chapter reports on the new theoretical and analytical aspects, reactivity, synthetic methods and uses, and biological applications of isothiazoles which have been developed in ten years (1996-2006). 

Part One should be completed by at least three evaluators from different countries, responsible for assessing product quality including pharmaceutical and analytical aspects. (The report should be no longer than six pages.)... 

The major contribution to establishing criteria for method transfer is to be found in the guide of International Society of Pharmaceutical Engineers (ISPE) [3]. While the analytical aspects of this guide relate to procedures used to measure active ingredients... 

All main aspects of analytical and bioanalytical sciences is covered by the conference program. AC CA-05 consists of 12 invited lectures and seven symposia General Aspects of Analytical Chemistry, Analytical Methods, Objects of the Analysis,. Sensors and Tests, Separation and Pre-concentration, Pharmaceutical and Biomedical Analysis, History and Methodology of Analytical Chemistry. Conference program includes two special symposia Memorial one, dedicated to Anatoly Babko and Analytical Russian-Germany-Ukrainian symposium (ARGUS-9). 

Kinetics can also be applied to the optimization of process conditions, as in organic syntheses, analytical reactions, and chemical manufacturing. This last example constitutes an important aspect of chemical engineering. Yet another practical use of chemical kinetics is for the determination and control of the stability of commercial products such as pharmaceutical dosage forms, foods, paints, and metals. 

Several important aspects relevant to the implementation of fast LC technologies in pharmaceutical laboratories should be mentioned. First, increases in speed should not compromise the quality of the analytical data or the robustness of the chromatography. All methods must be reproducible and validatable to meet the applicable GMP and GLP requirements. Instrumentation should be easily maintained and have minimal downtime. 

The thirty-two different chapters meticulously divided into six parts invariably covers up analytical techniques being used in most of the Official Compendia. Each chapter categorically and explicitly deals with the introduction, theoretical aspect(s), instrumentation, typical examples of pharmaceutical analysis and cognate assays. 

Part—I has three chapters that exclusively deal with General Aspects of pharmaceutical analysis. Chapter 1 focuses on the pharmaceutical chemicals and their respective purity and management. Critical information with regard to description of the finished product, sampling procedures, bioavailability, identification tests, physical constants and miscellaneous characteristics, such as ash values, loss on drying, clarity and color of solution, specific tests, limit tests of metallic and non-metallic impurities, limits of moisture content, volatile and non-volatile matter and lastly residue on ignition have also been dealt with. Each section provides adequate procedural details supported by ample typical examples from the Official Compendia. Chapter 2 embraces the theory and technique of quantitative analysis with specific emphasis on volumetric analysis, volumetric apparatus, their specifications, standardization and utility. It also includes biomedical analytical chemistry, colorimetric assays, theory and assay of biochemicals, such as urea, bilirubin, cholesterol and enzymatic assays, such as alkaline phosphatase, lactate dehydrogenase, salient features of radioimmunoassay and automated methods of chemical analysis. Chapter 3 provides special emphasis on errors in pharmaceutical analysis and their statistical validation. The first aspect is related to errors in pharmaceutical analysis and embodies classification of errors, accuracy, precision and makes... 

Part—VI has been solely devoted to Miscellaneous Assay Methods wherein radioimmunoassay (RIA) (Chapter 32) has been discussed extensively. Various arms of theoretical aspects viz., hapten determinants and purity importance of antigenic determinants and analysis of competitive antibody binding of isotopically labeled compounds. The applications of RIA in pharmaceutical analysis, such as morphine, hydromorphone and hydrocordone in human plasma clonazepam, flurazepam in human plasma chlordiazepoxide in plasma barbiturates, flunisolide in human plasma have been described elaborately. Lastly, the novel applications of RIA-techniques, combined RIA-technique-isotope dilution and stereospecificity have also been included to highlight the importance of RIA in the analytical armamentarium. 

QA requires the efficient analysis of many samples to support routine production release and stability programs. Methods are typically established in the analytical development group. Efficiency and convenience issues, including the speed of media preparation and the relative convenience of data handling and documentation, are important here. While compliance is important in all aspects of the pharmaceutical industry, QA functions must approach compliance perfection. Depending upon the facility, the automated apparatus may be tailored to specific methods with fixed configurations. Dissolution methods may be routine enough that a custom system, optimized for productivity, may be justified. Compliance of USP and use of industry standard apparatus is important to maintain compatibility with other company laboratories or in the case contract laboratory services are required. 

The second part deals with applications of solvent extraction in industry, and begins with a general chapter (Chapter 7) that involves both equipment, flowsheet development, economic factors, and environmental aspects. Chapter 8 is concerned with fundamental engineering concepts for multistage extraction. Chapter 9 describes contactor design. It is followed by the industrial extraction of organic and biochemical compounds for purification and pharmaceutical uses (Chapter 10), recovery of metals for industrial production (Chapter 11), applications in the nuclear fuel cycle (Chapter 12), and recycling or waste treatment (Chapter 14). Analytical applications are briefly summarized in Chapter 13. The last chapters, Chapters 15 and 16, describe some newer developments in which the principle of solvent extraction has or may come into use, and theoretical developments. 

Regulatory aspects of process analytics in the pharmaceutical industry - the concept of quaUty by design... 

The Patai Series publishes comprehensive reviews on all aspects of specific functional groups. Each volume contains outstanding surveys on theoretical and computational aspects, NMR, MS, other spectroscopical methods and analytical chemistry, structural aspects, thermochemistry, photochemistry, synthetic approaches and strategies, synthetic uses and applications in chemical and pharmaceutical industries, biological, biochemical and environmental aspects. 

APCI is widely used nowadays in different application fields for low molecular weight analytes. Many of them can either be analyzed with ESI or APCI, and the choice of the method should take into account several aspects, such as the physical-chemical properties of the molecule, the mobile phase composition and the required flow rate, and possible matrix effects. Typical APCI applications are in pharmaceutical, environmental, and food safety analysis. 

The first section of the book explores emerging novel aspects of HPLC and related separation methods based on the differential velocity of analytes in a liquid medium under the action of either an electric field (capillary electromigration techniques) or a gravitational field (field-flow fractionation). The section focusing on applications highlights four significant areas in which HPLC is successfully employed chiral pharmaceutical, environmental analysis, food analysis, and forensic science. 

Titrimetric methods are still widely used in pharmaceutical analysis because of their robustness, cheapness and capability for high precision. The only requirement of an analytical method that they lack is specificity. This chapter covers the theoretical basis of most of the commonly used methods the practical aspects of titrations have been covered thoroughly by other textbooks. 

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