Degradation testing components

In a typical degradation test, a specimen from the PPE or, in some cases (e.g., a glove), the entire item is immersed in the pesticide for some period of time. At predetermined intervals, the specimen is removed, tested, and observed. In the laboratory, strength, puncture, and tear properties are commonly measured using a machine with which the specimen is stretched and the force required to stretch the specimen recorded. Significant increases or decreases (+20%) in any of the properties would be indicative of poor resistance to the pesticide formulation. Losses in these properties would generally result from the sorption of one or more components of the pesticide formulation by the glove material. 

Tonnesen HH, Moore DE. Photochemical degradation of components in drug formulations. Part 2 Selection of radiation sources in light stability testing. Pharm Tech 1993 5 27-34. 

Synthetic flue gas, rather than combustion gases, was used during the laboratory phase of testing. This allowed an independent determination of the effect on degradation of components of flue gas such as fly ash, percent O2, and certain sulfur species. 

Extractables and Leachables — Materials or components derived from the container and closure that have been transferred into the contained drag substance or drug product. Forced Degradation Testing Studies [ICH Q1B] — Studies undertaken to degrade the sample deliberately. These studies, which may be undertaken in the development phase normally on the drug substances, are used to evaluate the overall photosensitivity of the material for method development purposes or degradation pathway elucidation. 

In the wild or in outdoor elephant enclosures, components in preovulatory urine or test components added to nonestrous urine are subjected to potential degradation, hydrolysis, oxidation, and ultraviolet radiation. Compounds that bind to Z7—12 Ac not only could be carriers but also could reduce these degradative processes and thus could prolong the effective life of pheromones. Proteins are substances that potentially can bind to pheromones... 

PEM Fuel Cell Failure Mode Analysis presents a systematic analysis of PEM fuel cell durability and failure modes. It provides readers with a fundamental understanding of insufficient fuel cell durability, identification of failure modes and failure mechanisms of PEM fuel cells, fuel cell component degradation testing, and mitigation strategies against degradation. 

The performance degradation component caused by accelerated stress must be decoupled from the measured data. The key performance parameters of instrument are often affected by many factors because of the complexity of its failure mechanism. How to decouple and fit the performance degradation caused by accelerated stress is one of the guarantees for implementing accelerated degradation test successfully. 

CREAM.dat A batch of cream containing two drug substances was put on stability and tested for at f = 0, 3, 7, and 24 months. Active component 1 remains stable, while AC2 degrades so fast that a shelf-life of only 26 months can be demonstrated for SL = 90%. Use with SHELFLIFE. 

---