Requirements in the United States

For drug substances and drug products, applications for enantiomers and racemates should include a stereochemically specific identity test and/or a stereochemically selective assay. The choice of control tests should be based on the method of manufacture and stability characteristics and, in the case of the finished product, its composition. 

Methods of assessing the stereochemical integrity of enantiomeric drug substances and drug products should be included in the stability protocols for both, but stereoselective tests may not be required once it has been shown that racemization does not occur. 

It is essential to determine the concentration of each isomer and define limits for all isomeric components, impurities, and contaminants of the compound tested preclin-ically that is intended for use in clinical trials. The maximum level of impurities in a stereoisomeric product used in clinical studies should not exceed that in the material evaluated in nonclinical toxicity studies. This point is expanded in the ICH impurities guideline (Section 13.5.3). 

1 Developing a Single Enantiomer after a Racemate is Studied 

The FDA s Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances makes some speeifie referenees to ehiral drug substanees. The requirements are similar to those in the EU. Elueidation of the 

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H. E. Wessel [Chem. Eng., 59, 209-210 (July 1952)] made a study of the operating-labor requirements in the United States chemical... 

The catalytic converters now used in automobiles can reduce NO to harmless N2. They are required in the United States for all new cars and trucks (see Section 13.14). 

Pesticide mobility studies, 18 546 Pesticide registration requirements, in the United States, 18 543-550 Pesticide regulation, 18 524, 536-543. See also Pesticide regulations role of international organizations in,... 

C86100 Sludge Compost Marketing and Distribution Regulatory Requirements in the United States... 

Reproductive toxicology, usually embryo/ foetal development studies in two species, is required in Europe and Japan if women of childbearing potential are included. Not required in the United States for some early trials... 

Ca requirements in the United States are currently set as AIs. The recommended AI for Ca is an approximated value estimated to cover the needs of all healthy individuals in the age group based on experimental or observational data that show a mean intake which appears to sustain a desired indicator of health (e.g., desirable Ca retention) however, lack of sufficient evidence precludes specifying with confidence the percentage of individuals covered by this intake (Standing Committee of the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, and Institute of Medicine, 1997). 

Until recently the requirements for the evaluation of the environmental impact of APIs were rudimentary and only required in the United States and Europe. 

Saccharin is noncaloric and noncariogenic (2,3). The safety of saccharin for public health has been the center of several controversies. In 1970, saccharin at high dietary levels was observed to increase the incidence of urinary bladder cancer in experimental rats (1,59). However, extensive human epidemiological investigations showed that use of saccharin does not significantly increase the risk of bladder cancer (5,7,11,59). Saccharin is approved for use in several countries. Its use is not permitted in Canada, and a health warning on the label of saccharin-containing foods is required in the United States (7,8,10). 

Stringent regulatory requirements in the United States often require the incorporation of fish protection facilities at power plant intakes. There are three different concepts that can be used fish collection and removal, fish diversion, and fish deterrance. The incorporation of fish protection systems at specific sites can necessitate modifications to conventional intake designs. Such modifications can influence screen-well layouts and selection of screens and pumps, and in certain cases require model studies to develop design criteria which will ensure that fish protection facilities will be biologically effective and not adversely affect plant operations. 9 refs, cited. 

Most biocide products continue to be sold under some form of brand name, which often does not properly describe the active materials contained (although the precise active chemicals are normally listed in the health and safety sheets). However, increasingly around the world, it is becoming necessary to provide all relevant information on the product label, in an approved manner, and for the company whose name appears on the label to be properly subregistered with the relevant authorities. (This has been required in the United States for many years.) This original registration and... 

There are many predictions of petroleum resource and supply models and many of these predictions have failed (Linden, 1998). However, the reality is that the United States is one of the largest importers of petroleum since domestic production is only about 64% of what it was in 1975. Domestic production of crude oil has fallen from approximately 10,000,000 barrels a day in 1975 to 6,400,000 at the end of 1998. At the same time, the total daily imports of foreign crude oil and products into the United States at the end of 1998 was approximately 10,000,000 barrels. Thus, imported crude oil and products represent approximately 61% of the daily crude oil requirements in the United States (Oil Gas Journal, 1998 Pellegrino, 1998). These data do not include liquids produced... 

The European patent equivalent to the nonobviousness requirement in the United States is referred to as the inventive step requirement. Although the terminology is different, the overall effect is generally the... 

It is important to point out that the abovementioned regulations do not include any requirements in the United States for construction products (building products) or electrical wires and cables (or their optical fiber equivalents), other than in some transportation vehicles. As explained earlier, these requirements are contained in codes, which may be adopted into regulation. Most other developed countries have government-mandated regulation for such products. 

Many workplace, environmental, food safety, and other regulations apply to oilseed and oil processors (55). Some of the regulations required in the United States are discussed. Many other countries have similar requirements, but if they do not, it would be prudent for oilseed solvent extraction operations and vegetable oil processors to consider meeting these regulations and for these industries to have environmental, health and safety, and quality management programs (135, 136). 

It is now required in the United States that commercial explosives should be tagged in such a way that the detection and post-detonation identification of explosives should be possible. Materials added to explosives for these purposes are called taggants. 

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