Substantial change, product

Refiner A firm or the part of a firm that refines products or blends and substantially changes products refines liquid hydrocarbons from oil and gas field gases or recovers liquefied petroleum gases incident to petroleum refining and sells those products to resellers, retailers or ultimate consumers. Includes gas plant operators. 

One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if (a) the seller is engaged in the business of selling such a product, and (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold. 

Very interestingly, the regioselectivity of the palladium-catalyzed hydrophosphinylation can be switched by addition of a tiny quantity of diphenylphosphinic acid or other acidic compounds (Scheme 39) [35]. Thus, the linear product (19 8), which is the major product under normal conditions (i.e., without the phosphinic acid), becomes the minor regioisomer, and instead, the branched isomer (19a) is formed as the prevailing product. Furthermore, the addition of the phosphinic acid enhances the catalytic activity. Note that the quantity of the palladium catalyst is 5 mol% relative to the reactant, and that the addition of only 1 mol% (relative to the reactant) of the phosphinic acid results in a substantial change in the regioselectivity. New palladium species, which are much more active in the catalysis, appear to be generated upon addition of the phosphinic acid or other acidic additives. 

Decomposition rates of some organic substrates are reduced. Substantial changes in the species composition of primary producers occur. The richness of phytoplankton species is reduced, while biomass and productivity of phytoplankton are not reduced by acidification. The biomass of herbivorous and predaceous zooplankton is probably reduced because of reductions in numbers of organisms and/or reduction in their average size. Many benthic invertebrates such as species of snails, clams, crayfish, amphipods, and various aquatic insects are intolerant of low pH and are seldom found in acidic lakes. However, certain large aquatic insects such as water boatmen and gyrinids are very acid tolerant and may become the top predators in some acidified lakes. Acidification of aquatic systems has major effects on fish population. 

This brief survey of the FDA regulation of pharmaceutical products demonstrates the breadth and depth of FDA activity in this field. Although there are repeated calls for reform of the IND/NDA system, it appears unlikely that any substantial change will occur in the near future. It is therefore important that any person who enters the prescription drug industry in the United States be fully informed about the requirements, understand the regulatory risks involved, and comply adequately with all of the FDA requirements. 

Changing the composition of the aqueous phase (1 mol L 1 lactic acid + 0.05 mol L 1 DTPA or HN03 3 mol L ) has a negligible effect on the global yields of HDEHP decomposition products in solution. However, substantial changes have been observed in the gaseous composition in the presence of lactic acid (the yields of H2 doubled and C02 appeared, whereas 02 completely disappeared), and the amount of oxidation products increased, contrary to nitration derivatives, which decreased (12). 

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