Stability testing process

Lyng, S.M.O., Passos, M., and Fontana, J.D. (2005). Bixin and alpha-cyclodextrin inclusion complex and stability tests. Process Biochem. 40, 865-872. 

Use of thermal stability tests (DTA s) to determine the heat sensitivity of a given process mixture is desirable. Recent advances in analytical methods permit good calorimetric determination of heat of reaction. Heat of reaction data are critical for exothermic reactor vent sizing. Heat impact from fire is usually small in comparison, but should not be neglected. 

Specialized LIMS— This type of LIMS is based on the fact that certain laboratories have a range of well-defined processes (e.g., stability testing) that are performed according to a specific set of regulations and by using well-established tests. The tests are done according to industry-wide accepted protocols. Specialized LIMS are tailor-made for certain types of laboratories. Therefore the performance can be optimized for clearly defined work process. 

Interim collection of processed material Interim physical characterization Interim chemical characterization Stability testing Packaging I... 

Isolation of the products from complex matrixes (e.g. polymer and water, air, or soil) is often a demanding task. In the process of stability testing (10 days at 40 °C, 1 h at reflux temperature) of selected plastic additives (DEHA, DEHP and Irganox 1076) in EU aqueous simulants, the additive samples after exposure were simply extracted from the aqueous simulants with hexane [63]. A sonication step was necessary to ensure maximum extraction of control samples. Albertsson et al. developed several sample preparation techniques using headspace-GC-MS [64], LLE [65] and SPE [66-68]. A practical guide to LLE is available [3]. 

Before undertaking a discussion of the mathematics involved in the determination of reaction rates is undertaken, it is necessary to point out the importance of proper data acquisition in stability testing. Applications of rate equations and predictions are meaningful only if the data utilized in such processes are collected using valid statistical and analytical procedures. It is beyond the scope of this chapter to discuss the proper statistical treatments and analytical techniques that should be used in a stability study. Some perspectives in these areas can be obtained by reading the comprehensive review by Meites [84], the paper by P. Wessels et al. [85], and the section on statistical considerations in the stability guidelines published by FDA in 1987 [86] and in the more recent Guidance for Industry published in June 1998 [87],... 

CPMP/QWP/2570/98 Concept paper on the development of a CPMP note for guidance on in-use stability testing of non-sterile human medicinal products (November 1998) CPMP/QWP/2934/99 draft Note for guidance on in-use stability testing of human medicinal products (released for comment December 1999) CPMP/QWP/598/99 draft Note for guidance on process validation (released for comment September 1999, also issued under CVMP reference EMEA/CVMP/598/99 draft) CPMP/QWP/486/95 Note for guidance on manufacture of the finished dosage form (reissued April 1996)... 

Gopa et al. [23] reported about open Zeolite/water systems for the storage of solar heat. In their work they were presenting stability tests, methods for the definition of the adsorption enthalpy in dependence on the adsorbed amount of water and the possible heating power during the discharging process. 

Dartnell, R. C. et al., Loss Prev., 1971, 5, 53-56 MCA Case History No. 1649 A batch of 8 t of material accumulated in storage at 154°C during 72 h decomposed explosively. Stability tests showed that thermal instability developed when 3-methyl-4-nitrophenol is stored molten at temperatures above 140°C. Decomposition set in after 14 h at 185° or 45 h at 165°, with peak temperatures of 593 and 521°C, respectively. In a closed vessel, a peak pressure of 750 bar was attained, with a maximum rate of increase of 40 kbar/s. Thermal degradation involves an initially slow exothermic free radical polymerisation process, followed by a rapid and violently exothermic decomposition at take-off. 

Commercial MgO was impregnated with Ni acetate in toluene solution. Addition of 1-3 wt% K suppresses the Ni sintering and extends the catalyst stability. Catalysts were evaluated for 500 h endurance test. Process reported to be suitable for producing H2 for MCFC... 

In summary, TLC analysis plays a critical role in the drug development process. Many instruments are available, and the technique is used for both quantitative and qualitative testing. i f determination, identity testing, and stability testing are just a few ways to utilize TLC. 

Those stages after the preclinical discovery and evaluation that involve technical development. These processes include formulation work, stability testing, scaling-up the compound for larger-scale synthesis, and providing analytical support. Clinical trials are not included in this definition. 

Many of the steps involved in a risk-based approach are comparable to the standard transfer paradigm, but the risk-based approach requires significantly more upfront activities to better understand both process and methods. This increased investment increases both the likelihood of successful transfer, the risk of observing a step-change for ongoing stability testing, which could affect shelf-life of the product and the likelihood of future OOS investigations. 

In-Process Testing Packaging and Labeling of Finished BPC Expiration Dating or Reevaluation Dating Laboratory Controls Stability Testing... 

B. Stability Testing at Different Phases of the Drug Development Process... 

Dissolution is one of the most time-consuming tests in stability testing, clinical release, and process support of pharmaceutical dosage... 

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. 

---