Test method development

Ionomer resins are produced in multiple grades to meet market needs, and prospective customers are provided with information on key processing parameters such as melt-flow index. Nominal values for many other properties are Hsted in product brochures. The ASTM test methods developed for general-purpose thermoplastic resins are appHcable to ionomers. No special methods have been introduced specifically for the ionomers. 

Drug substance/drug product purity, potency, and other testing Drug substance/drug product stability testing Method development, validation, and transfer Drug product formulation development... 

Issue Industry and the regulatory authorities need to agree on (1) what constitutes a valid efficacy claim for each product type, (2) the test methods used to generate data in support of these claims and (3) a test method development strategy and plan for the most critical areas where methods are inadequate or missing. 

In many definitions, reference is made to ASTM methods. These are carefully controlled test methods developed by the American Society for Testing and Materials (ASTM), a scientific and technical organization founded in 1898 to establish standards for products, systems, and... 

Endeavors promoting development, validation and refinement of toxicity testing procedures 3.1.1 Test method development 3.1.2 Inter-calibration exercises 3.1.3 Comparative studies... 

Although several standard test methods have been developed for the chemical analysis of catalysts only small samples of supported platinum and palladium reference materials are available. Zeolites have been characterized for zeolite area, unit cell dimensions, and relative x-ray diffraction intensity. The crush strength of alumina pellets has also been determined. As the needs of catalyst users and producers change so will the materials characterized. To the extent that adequate amounts of material can be donated, standard test methods developed, and round robin tests performed Committee D-32 on catalysts will continue to make them available through NIST as reference materials. 

Resistance to the Solvent Action of Fuels. Sulfur—asphalt concretes were less affected by the solvent action of fuels than was normal asphaltic concrete. The solvent action of three fuels—gasoline, JP-4 jet fuel, and No. 2 diesel fuel—was tested on samples of normal asphaltic concrete and on 15-, 25-, and 35-vol % sulfur-asphalt concretes. Two test methods developed by McBee (15) were used to determine loss in weight and loss of stability on drip and total immersion testing of Marshall compaction samples. 

We will now discuss some of the reasons why mold allergens are more difficult to standardize than other aeroallergens such as pollen allergens and why some of the commercially available extracts are very poor when analyzed for the presence of major allergens. These commercial extracts were also inferior to pure recombinant allergens when compared in clinical tests. Methods developed in our laboratory for optimal production and extraction of mold allergens will be described. 

Problems in applying test methods developed for non-metal... 

A more rapid test method, developed by the British Textile Technology Group in the late 1980s, is based on adenosine triphosphate (ATP) luminescence. The growth of microorganisms is assessed by firefly bioluminescent detection and ATP analysis. ... 

The availability of reliable test methods for contaminated sediments is relatively recent and the test method development process continues. A variety of issues remain to be solved before these types of studies will be considered as effective as those with planktonic species. Among the more important of these issues are validation of the single-species test results and determination of variations in species sensitivity. 

Originally limited to ellipsoids, the use of Mahalonobis distances allows the use of more variables as the confidence ellipsoid can be transformed to a confidence or tolerance hypersphere. These ideas were examined using the microecosystem test method developed by Kersting for the examination of multispecies systems. These three-compartment microecosystems are comprised of an autotrophic, herbivore, and decomposer subsystems that are connected by tubing and pumps. Although relatively simple and small, these systems are operable over a number of years. 

Test method development and the derivation of quality control... 

Fire-test method development has followed two separate but complementary paths. One path, theoretically oriented, is characterized by the measuring of scientifically-meaningful fire properties, such as mass loss and rate-of-heat release. This approach also includes the development of mathematical models incorporating these properties to predict propagation and flame spread. A new lab-scale apparatus, the "cone calorimeter" developed at NIST is an example of the hardware now available to measure these fire properties. 

Asphalt is prepared from a distillation residuum, and therefore the need for distillation data is limited. Vacuum distillation data (ASTM D-1160) will be valuable for composition purposes if the asphalt is prepared from an atmospheric residuum. Approximate amounts of volatile constituents can also be determined by test methods developed for other products (ASTM D-20, ASTM D-402, ASTM D-3607, ASTM D-4893) but that are particularly applicable to cutback asphalt. 

Different engine lubricant testing approvals arise from different attitudes and philosophies in different continents and also different countries within those continents. Issues are now addressed internationally by new test method development and procedures for specifying lubricant qualities, leading to new approval systems. These developments benefit engine and equipment manufacturers, producers of lubricants and additives and, ultimately, users of mechanical systems of whatever form in an eventually international marketplace. 

Active Batch analysis certificate of analysis test methods developing Draft specification test methods developed and validated Full specification test methods developed and validated Full specification test methods developed and validated... 

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