Methods and Specifications

In 1903 an American Society for Testing and Materials (ASTM) Committee on Road and Paving Materials was formed to develop test methods and specifications for highway materials. Test methods for volatilization, penetration, and bitumen were developed by the Office of PubHc Roads and were... 

Process and Operating Conditions The major parameters that must be fixed or identified are the solvent to be used, the temperature, the terminal stream compositions and quantities, leaching cycle (batch or continuous), contact method, and specific extractor choice. 

Analytical methods and specifications for the component materials, intermediates, and the final product... 

Analytical methods and specifications must be established and validated so as to define and control the quality and purity of the raw materials, intermediates and the finished product. For many standard chemical raw materials, the development of specifications will not be necessary as they are already published in US and European pharmacopoeia (for example, standards for water, organic solvents and various excipients). The ultimate objective of these activities is to be able to manufacture the drugs required for clinical trials in accordance with good manufacturing practice (GMP). 

The QA/QC lab, then, would particularly benefit from LIMS technology which would mechanize the collection and analysis of data from routine tests, which would assure and document adherence to appropriate test methods and specifications, and which would include automatic limit checking and pass/fail determination. 

See also Methacrylate monomers polymerization data for, 16 279t Methacrylic ester polymers, 16 271-298. See also Methacrylate monomers Methacrylic esters analytical test methods and specifications for, 16 291-293 bulk polymerization of, 16 281-282 chemical properties of, 16 276-277 electrical properties of, 16 276 emulsion polymerization of, 16 285-288 glass transition temperature of, 16 273-274... 

Performance Qualification (PQ) This provides documented verification that the equipment and ancillary systems, when connected together, can perform effectively and reproducibly based on the approved process method and specifications. 

Types of water, methods, and specifications for testing are listed in the USP Informational Chapter (1231) Water for Pharmaceutical Purposes. The USP also references... 

Ganjah R etal., Classical methods and specific primers in detection of endophytic fungi in some gramineuos plants, Rostaniha 5 15—18, 2004. 

Storage and retrieval of methods and specifications. -Comparison of measurements to specifications. 

Raw materials (tests, methods and specifications) Audit of the data submitted for CDER review in the application is a Field responsibility. CDER chemists are responsible for the scientific review of the associated data, evaluations of the adequacy of the submitted data, and ultimate approval of the tests, methods, and specifications established for the raw materials in the application. 

Process challenging and characterization reports that contain a full description of the studies performed Development batch record Raw material test methods and specifications... 

Manufacturing process change New validation protocol Stability protocol revisions for expanded accelerated and long-term stability Update methods validation Master and batch record revisions Methods and specifications revisions... 

In this chapter, the ultrafast radiationless transition processes are treated theoretically. The method employed is based on the density matrix method, and specifically, a generalized linear response theory is developed by applying the projection operator technique on the Liouville equation so that non-equilibrium cases can be handled properly. The ultrafast molecular... 

By changing the method and specific parameters of the silica preparation, surface area, pore volume, pore size and particle size are, to some extent, independently controllable. These are the four variables, governing the chemical and physical behaviour of silica. Each of them will be discussed in detail in the subsequent paragraphs. Initial interest is directed to the methods of preparation and the various types obtained. A survey of these methods and their main characteristics is presented in table 1.1. 

It will be permissible to apply the CE mark to sheets of High Pressure Laminate in accordance with the regulations contained in the European Construction Products Directive however, until European fire test methods and specifications are harmonized fire certification by individual countries still will be necessary. 

Physical situations that involve radiation with conduction and convection are fairly common. Examples include automobile radiators and heat transfer in the furnace of boilers and incinerators. The energy equations become more complex as they comprise both temperature differences coming from convection and temperature derivatives coming from conduction. Hence, there are no classical methods of solution, but numerical methods and specific methods for particular problems. 

Specifications and Analytical Methods. Describe the acceptance specifications and test methods used to assure the identity, strength, quality, and purity of the drug substance and the bioavailability of the drug products made from the drug substance. Any actual or potential impurities, by-products, and degradation products should be indicated. When test methods and specifications are established by an official compendium or other public standard, cite the standard used. 

The fourth section relates to the analytical methods used to measure the levels of the drug and major metabolites in body fluids. A table should be included in this section listing the study number, submission date, type of biological fluid, method used, sensitivity, and range of the method and specificity of the method for the parent compound and metabolites. 

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