Long-term stability tests

Figure 1. Photocurrent-photovoltage characteristics of the cell n-Si (Pt silicide coated)/1.0 M FeClg, 0.1 M FeCU, 1 M HCl/Pt at 65 nW/cm2 illumination. Pt thickness deposited 40 A and annealing temperature 400 °C at 10 6 torr for 10 min. Key a, before long-term stability test and b, after long-term stability test.

While freshly cleaved surfaces clearly contain some steps and other defects, the surfaces are remarkably stable to corrosion. Dramatic evidence of the stability of MoSe2 surfaces was provided by Stickney et al. who obtained LEED and Auger spectra of surfaces that had been exposed to the atmosphere and a variety of oxidizing solutions (35). Except for the presence of a ubiquitous carbon which was attributed to the epoxy resin or cleaving tape, no evidence for surface reactions was found. Long term stability tests of a photoelectrochemical cell made with a WSe2 electrode, where over 400,000 coulombs/cm2 were passed through the cell with no detectable photocorrosion, also attest to the durability of these surfaces (36). 

Chemistry—Application/compendial release requirements and stability testing. For stability testing, one batch should be on long-term stability testing with data being reported in the annual report. 

Filing documentation—A supplement should be hied showing the changes being effected. Long-term stability test data should be included in the annual report. 

Changes being effected supplement annual report (long-term stability test data). 

Long-term stability. As for a practical use, the long-term stability is one of the important factors. Figure 14 shows the results of a long-term stability test for the modified sensor at room temperature. Except for the beginning of the test period, the short circuit current to 1.3 vol% H2 in air was stable for about two months. The anomalously large current at the beginning has not been understood well yet. 

Long-term stability test of sensor system over a period of 1... 

Long-term stability tests of (1) palladium sheet electrodes and (2) woven, (3) knitted and (4) non-woven textile electrodes, obtained by measurement of R as a function of time in the electrochemical cell for NaCI electrolyte concentrations of (a) 1x10 4, (b) 1x10 3, (c) 1 x10 2 and (d) 1 x10 1 mol I-1. 

Fig. 11.8. Long-term stability test of anodically oxidized diamond electrode. The conditions of flow injection analysis were same as Fig. 11.7. After 100 injections, the electrode was regenerated on-line by anodic oxidation.

F. J. Ansuini and J. R. Dimond, Long-term stability testing of reference electrodes for reinforced concrete , Corrosion 94, Paper No. 295, NACE, Houston, TX, USA, 1994. 

Long-term stability testing should be at 25°C/45% relative humidity, FDA Advisory Committee concurs Testing standard should only apply to new drugs, FDA-77ie Pink Sheets, June 18, 1993, p. 9. 

Fig.20. The long-term stability (measured by TACAN Corporation) of a (PU-DR19) material. This material consists of a Disperse Red chromophore with one end attached to a polyurethane matrix. This long-term stability test was started in 1995 and no change in device halfwave voltage has been observed to the present time...

Long Term Stability Tests on High Power nc-DSC... 

The actual glucose sensor (a platinum electrode covered by three membranes ceUulose acetate, nylon net with covalently Unked GOD, and a polycarbonate protective membrane) is located in a miniaturized waU-jet cell. The sensor exhibits excellent performance, with a linear range extending up to 27 mM, thanks to the microdialysis dilution effect which was estimated to be 1 10 for the probe length used and for the flow rate set by the instrumentation. Long-term stability tests revealed that the biosensor stiU maintains its initial activity after incubations of 4 weeks at 45°C, 11 weeks at 37°C, and 32 weeks at room temperature (see Table 12.2). From these results, a shelf life of more than 2 years at 2-8°C can be extrapolated [119]. 

The initicil submission has to include stability data on accelerated and long-term stability testing conducted for at least for 6 months for at least 2 pilot batches. Upon launching the product, long-term stability testing has to be initiated for the first 3 batches manufactured, and reported at completion of the testing. 

Pending evaluation of the application by the authorities, both accelerated and long-term stability tests for a duration of 6 months of at least 2 pilot batches, must be carried out by the licensee. 

In both cases, upon the launching of the product, long-term stability testing of the first 3 batches manufactured has to be initiated and reported at completion. The directive defines the following t)T5es of stability testing ... 

Long-term stability testing of products intended for storage at room temperature... 

Sommeling P. M., Spath M., Smit H. J. P., Bakker N. J. and Kroon J. M. (2004), Long-term stability testing of dye-sensitized solar cells , J. Photoch. Photobio. A 164, 137-144. 

The first three production batches of drug substance manufactured after approval, if not a part of the original submission, should be selected for long-term stability testing using the same stability protocol submitted in the approved drug application. 

If the submission does not include stability data on any production batches, a commitment to select the first three production batches for long-term stability testing and to continue testing through the proposed re-test period must be made. 

The material showed a significant decrease of the mean z after 38 days of storage at 5°C and 22°C (enumeration procedure). Also at -20°C of the long term stability test a... 

There is also the possibility of constituents from label adhesives migrating through polyethylene or polypropylene containers. This is something to be aware of when carrying out stressed compatibility testing and long-term stability testing. 

Evaluate the ITM Syngas/ITM H2 processes using PDU data Conduct long-term stability tests of tubular membranes and seals at high pressure Demonstrate performance of pilot-scale membrane modules in PDU Complete membrane module design and select catalysts for the SEP Commission the ceramic Production Development Facility and fabricate SEP membranes Design and fabricate the SEP reactor... 

Figure 4.43. (a) Automated FIA manifold used for the determination of nitrate by reduction to nitrite with spectrophometric detection (cf. Fig. 4.5). The sample (30 p.L), aspirated from the sample changer 5, is injected into a 0.25 M acetate solution of pH 6.0 (A) and then carried to the reduction column, which is filled with small zinc chips. The nitrite produced is then mixed with the color-forming reagent solution R. (b) Long-term stability test of the nitrate reduction column used in the system shown in (a). A series of samples (1.0-10 ppm N-NO3), each injected in triplicate, were placed in the sample changer and the system was operated continuously for 6 h every day over a period of 3 days (sampling rate 180 samples/ h). Not until the third day did the column show signs of gradually reduced efficiency.

Last but not least, point 6 in Fig. 40.4 shows the importance of long-term stability tests of the drug product. Often together with the carcinogenicity studies their availability trigger the submission process and therefore they are project-wise on the critical path. 

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