Continuous Stability Test

Stability Stability protocols and data should be submitted, along with the commitment and protocols to continue stability testing post-approval. 

Continuous stability, test for explostves, 79 Copper value " of cellulose, 16 Cordite, stalMUty tests for, 73,81 Cotton ceUutose, j6 CupTummonium, 19 Cuprene, I3... 

In the same way that the Routh-Hurwitz criterion offers a simple method of determining the stability of continuous systems, the Jury (1958) stability test is employed in a similar manner to assess the stability of discrete systems. 

The Ni/Re on carbon catalyst was also evaluated in a 1700 hour continuous reactor test to determine the stability of the catalyst. This test was performed with a different model compound than xylitol. Shown in Figure 5, the results from the lifetime test of the Ni/Re catalyst operated at constant process conditions sampled intermittently for 1700 hours. This shows that for a similar aqueous hydrogenation reaction deliberately operated to near completion, the catalyst retained its activity and product selectivity even in the face of multiple feed and H2 interruptions. We feel that this data readily suggests that the Ni/Re catalyst will retain its activity for xylitol hydrogenolysis. 

Figure 2.4, a continuation of Figure 2.3, is a flow chart for a strategy for stability testing. The main aim of these tests is the determination of the following parameters ... 

Once the optimal formulation and processing method have been determined and the most suitable packaging configuration decided, product stability tests may be commenced. The aim is to determine a shelf life and provide data that demonstrate the product s continued quality under the conditions of manufacture, storage. 

Heat Tests. Under this term may be placed all the stability tests which involve heating an explosive, eg Abel Heat Test, Acidity Measurements (pH measurements), American Test at 65.5° or 80°, Bergmann-Junk Test, Brame s Test, Brunswig s Test, Chiaraviglio Corbino Test, Conductivity Method (De Bruin de Pauw) Continuous Test, Deflagration Test, Desmaroux Test, Dupre s Vacuum Test, Dutch Test,... 

Ditto in 1/8 Al—50% expls and 50% unaffected Sand Test-See Brisance by Sand Test Sensitivity to Impact—See Impact Sensitivity Sensitivity to Initiation—See Initiation, Sensitivity to Stability Test—See Vacuum Stability Test Vacuum Stability Test at 120°—0.37cc of gas evolved in 40 hrs from 1 g sample Velocity of Detonation—See Detonation Rate Viscosity, Efflux-24.8 Saybolt Seconds Method of manuf of HTA—3 is similar to that used for Torpex, namely purified TNT is melted by heating it to ca 100° in a steam-jacketed kettle, equipped with a stirrer. Water wet HMX is added slowly to molten TNT, while continuing to stir it and to heat, until all the water is evapd. Aluminum powder is added and the mixture continued to be stirred until uniform and then cooled, with stirring, to obtain a slurry suitable for pouring into shells or bombs to serve as their bursting charges Refs 1) G. Silvestro H. Will III, PA Instrumentation Rept 1232—58 (1958) (Suitability of HTA-3 as HE) 2) Anon, AMCP 706-177 (1967), pp 178-81 362 (Torpex) (1971), pp 178-81... 

Figure 18 Stability test carried out with two sealed DSSCs over 7000 hr of continuous illumination with visible light (polycarbonate 395-nm cutoff filter) at 1000 W/m2 light intensity. The photocurrent and voltage drop measured across an external load resistor of 10 ft are plotted as a function of irradiation time. Cell 1 (solid line) was continuously illuminated at 35°C the same for cell 2 (broken line) except that it was operated for a 700-hr period at 75°C and for 1000 hr at an open circuit. (From Ref. 153.)...

A number of reference materials for vitamins in foods are under development. Extensive analysis and stability testing have been conducted to assess the potential of vitamin-enriched milk powder, wholemeal flour, and margarine as well as lyophilized brussels sprouts, mixed vegetables, and pork liver for use as reference materials (193-196). The certification study for vitamin C in the brussels sprouts reference material has been completed. However, methodology problems continue to have a significant negative effect on the development of reference materials. 

Modolo, G., Asp, H., Vijgen H., Malmbeck, R., Magnusson, D., Sorel, C. 2007. Demonstration of a TODGA-based continuous counter-current extraction process for the partitioning of actinides from a PUREX raffinate. Part I batch extraction optimization studies and stability tests. Solvent Extr. Ion Exch. 25 703-721. 

A sterility failure is sufficient reason not to release product and may eventually lead to the need to destroy it. A periodic assessment of stability test failures and retest trends would alert QA to investigate any possible risks associated with the continued distribution of that particular product. 

Researchers at Lockheed-Martin have fabricated push-pull Mach-Zehnder modulators using FTC in APC. They observed drive voltages near 1 V and these modulators exhibited good stability for periods of 3 months (with stability testing continuing) [253]. 

This method for the stability testing of propellants was proposed by Vieille in 1896. The sample is heated at 110 °C (230 °F) in the presence of a strip of litmus paper, and is then exposed to air at room temperature overnight, after which the cycle is repeated. This treatment is continued until the litmus paper turns red within one hour. The overall duration of the heating operations thus performed is a measure of the stability. 

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