Tìm thấy 20+ kết quả cho từ khóa "Pharmaceutical Scientists 2007"
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It was a rare example of a dramatic effect of the existence of multiple crystal forms of a commercial pharmaceutical and showed the importance of poly- morphic screening for all type of pharmaceutical dosage forms. When the exis- tence of polymorphism for new chemical entity is identified, the property of practical interest is the relative thermodynamic stability of the identified poly- morphs. As can be seen from Figure 12-5, intersecting solubility curves (dependence of the logarithm of the.
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By the time an active pharmaceutical ingredient (API) is made available to an analytical chemist in the formulation development group, most or all of the physical characteristics of an API has already been studied and the informa- tion should be available in some sort of a report from the drug substance group or preformulation group.
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These impurities, however, are likely to contain compo- nents that affect the purity of the final manufactured pharmaceutical. By- products are often generated during synthesis and are one of the major sources of pharmaceutical impurities. The identification of the by-products often allows the Development Operations to refine the manufacturing process to minimize impurities and, thus, to maximize yield.. of the impu- rities A, D, E, F, G were found to be at m/z and 558, respectively.
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During early development of the active pharmaceutical ingredient and early dosage form development, emphasis is placed on speed and quantitation of the API.
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Therefore the stability-indicating methods should be rugged and robust and meet all validation requirements that will allow for determining the purity of the active pharmaceutical ingredient throughout the duration of the support- ive stability studies. Methods should be able to sepa- rate the active pharmaceutical ingredient (API) from the drug product degra- dation products, excipients, excipient degradation products, and any synthetic impurities that are present in the API.
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Albertini, Toxicogenomics in the pharmaceutical industry: Hollow promises or real benefit, Mutat
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A large number of chiral stationary phases are currently avail- able to meet the needs of the pharmaceutical industry for determination of the enantiomeric purity of active pharmaceutical ingredients, raw materials, and metabolites. Combined with the ability to use low-UV-cutoff mobile-phase solvents, one can gener- ally detect 0.1% of the enantiomeric impurity. of the separations.
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The shift from late-stage optimization of ADME properties to a strategy of identifying potential liabilities early in the discovery process has taken hold within the pharmaceutical community, adding the dimension of structure–ADME relationships in parallel to structure–activity relation- ships as an integral part of the iterative drug discovery process..
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One of their obser- vations was that the resolution of the NMR spectra in the LC-NMR system 904 LC-NMR OVERVIEW AND PHARMACEUTICAL APPLICATIONS.
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Pharmaceutical Applications of Superheated Water Chromatography. SUPERHEATED WATER CHROMATOGRAPHY 825. Separation of barbiturates on PS-DVB column at 200°C with water as the eluent. 18.6 SUBAMBIENT SEPARATIONS.
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These equilibria are also secondary processes that influence the analyte retention and selectivity and are of primary concern in the development of the separation methods for most pharmaceutical compounds.. This brief descriptive overview of the reversed-phase process emphasizes the complexity of the retention mechanism and the necessity to consider the influence of different and independent processes on the analyte retention..
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The hold at higher organic concentration is usually employed for compounds during early development in the event that more hydrophobic species are formed either during the processing (i.e., change in synthetic routes, hold point stability, etc.) or during solid-state stability studies of the active pharmaceutical ingredient or drug product..
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Separation of optically active isomers is one of the most important areas of HPLC application in the pharmaceutical industry. Higher long-term stability of polysaccharide phases was achieved with covalent bonding of polysaccharide to the surface of the support [83].. 1,2-a]pyridine on chiral-AGP column and pH dependence of the retention of (R) and (S) forms of solute 1. Comparison of the porous structure of different columns was discussed in Section 3.2.
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In the future, with the advent of new station- ary phases being developed, one should expect to see increasingly more interesting applications in the pharmaceutical industry.. Schunk, Retention mechanism and the role of the mobile phase in normal-phase separation on amino-bonded-phase columns, Anal. Soczewinski, Solvent composition effects in thin-layer chromatography systems of the type silica gel-electron donor solvent, Anal. Alain, Normal-Phase Liquid Chromatography, in E.
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DOLE, the ethyl ester of quinoline mevalonic acid (structure shown in Table 21-4), is a pharmaceutical intermediate of the cholesterol-reducing drug substance NK-104. A small proportion of the main stream leaving the column flows through a by- pass from which the samples are taken automatically (Figure 21-23).
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The chaotropic theory was shown to be applicable in many cases where small inorganic ions were used for the alteration of the retention of basic pharmaceutical compounds [153–157]. Equation (4-39) essentially attributes the upper retention limit for completely desolvated analyte to the hydrophobic properties of the analyte alone.
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Beijnen, Development of a LC method for pharmaceutical quality control of the antimetastatic ruthenium complex NAMI-A, J
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One of the more common approaches to method development in the drug substance and drug product groups in the pharmaceutical industry is to first generate forced-decomposition samples (using mild conditions, not more than 5–10% degradation) based on treatment of the compounds with various stress conditions including, typically, UV light, heat, acid, base, and peroxide.
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The chromatographic method was not appreciated among the scientists at the time of the discovery, as well as after almost 10 years when L. Horvath was forced to build an instrument that allowed develop- ment of a continuous flow of the liquid through the column [11]. Later in 2001, he further defined the meaning of the word. “performance” as “an aggregate of the efficiency parameters” shown in Figure 1-3..
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Rapid development of MS in recent decades has further expanded its role in the structural characterization of small molecules in the drug discovery process [1].. In combination with chromatographic separation techniques, principally in the form of high-performance liquid chromatography (HPLC. In addition, control of internal energy deposited on ions during ionization should be achievable in the ionization source to control...