Stability evaluation

Turkoglu M, Varol H, Celikok M. Tableting and stability evaluation of enteric-coated omeprazole pellets. Eur J Pharm Biopharm 2004 57 277-86. 

Nevertheless, Ni(-Fe)-Cr base alloys may find application as interconnect materials through the use of innovative SOFC stack and seal designs and novel interconnect structures. For example, a cladding approach has been applied to fabricate a stable composite interconnect structure consisting of FCC Ni-Cr base alloy claddings on a BCC FSS substrate [134,135], The clad structure appeared to be stable over 1000 hours at 800°C in air and exhibited a linear CTE close to that of the FSS, but needs further long-term stability evaluation before its commercial use. 

Water system Cleaning practices Computer validation Process validation Test methods validation Sterilization procedures Stability evaluation... 

Isoproterenol, chemiluminescence, 647 (—)-Isopulegol, artemisinin synthesis, 277, 278 Isothermal microcalorimetry, oxidation stability evaluation, 672 Isotopomers... 

TABLE 1 Storage Conditions for Stability Evaluation of APIs... 

The temperature accuracy of the column heater is evaluated by placing a calibrated thermometer in the column compartment to measure the actual compartment temperature. The thermometer readings are compared to the preset temperature at 40 and 60°C. Many LC equipment manufacturers have the requirement set at 2°C. The temperature stability of the column compartment can be assessed indirectly by comparing the retention time of certain peaks in the chromatogram over time. Acceptance criteria of the stability evaluation should be assessed on a case-by-case basis due to different laboratory conditions and environment. 

A storage statement should be established for the labeling in accordance with relevant national and regional requirements. The statement should be based on the stability evaluation of the drug substance. Where applicable, specific instructions should be provided, in particular for... 

Tan, C.P., Nakajima, M. (2005). fi-Carotene nanodispersions preparation, characterization and stability evaluation. Food Chemistry, 92, 661 -671. 

Yuan, Y., Gao, Y., Zhao, J., Mao, L. (2008). Characterization and stability evaluation of p-carotene nanoemulsions prepared by high pressure homogenization under various emulsifying conditions. Food Research International, 41, 61-68. 

For accurate stability evaluations, at least 10 to 12 samples should be withdrawn. 

Oxidative degradation is as important as hydrolysis in the stability evaluation of new drug substances. The oxygen concentration in solution is a factor in many cases and often depends upon the solvent employed. It was reported that ascorbic acid is more stable in 90% propylene glycol or in Syrup USP than in water, presumably because of the lower oxygen concentration in these vehicles (Ravin and Radebaugh, 1990). 

APV (1981) International Association for Pharmaceutical Technology Praxis der Validierung (Validation in Practice), Symposium (1981-1982, Gelsenkirchen) [6] Terminology, sterile, semisolid, and solid dosage forms in development and production, analytical methods and stability evaluation, packaging development and packaging validation transfer, cost-effectiveness... 

In contrast, Pt18Co62Ru20 is an active composition on the Pt-rich side of the activity maximum. A similar stability evaluation reveals relatively stable behavior, as shown in Fig. 11.19. This composition is similar to the original catalyst identified during the broad screening study. Diffraction after screening is substantially similar to that before screening (Fig. 11.19b), and EDX data before and after screening indicate stability (Fig. 11.19 c). 

Sampling batches from production for stability evaluation Sampling units from batches for stability studies Sampling units from stability study for testing Sampling analytical samples from units selected for testing Number of units... 

There are several remarkable features of this isotope-exchange assay. If the reaction progress is followed, equilibrium of isotope exchange is attained at a defined distribution of the label between ATP and PPi. This has been shown in the case of ACV synthetase by Baldwin and colleagues [57], but is rarely done because of the restrictions of enzyme stability. Evaluation of this equilibrium, which has been reached in the case of the A. chrysogenum enzyme in about 3 hr, has never been attempted, but the concentrations roughly reflect the initial rates of the exchange reactions. 

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