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Stability chamber for drug validity stability

Factors influencing the test purpose is to clear the degradation of drugs may way, preliminary determine the packing of the drugs, storage conditions, and accelerated test conditions, and verify the rationality of the prescription and the feasibility of the method; The purpose of the accelerated test is to determine the degradation of the drug under normal storage conditions and the conditions for determining the long-term retention samples. The purpose of long-term stability test is to confirm the results of influencing factor test and accelerated test, to determine the change of drug stability test box and determine the validity of the drug. It should be said that the long-term retention test is the core of the Stability test chamber.
Drug development is a systematic project, however, from the world of research and development to production, has many stages, including basic research, the establishment and development of the model, preclinical research, clinical trials, and register for examination and approval and production listed such as stage, test in pharmaceutical research should experience by the enlarged step by step process mass production, how to realize the stability test of different development scale samples in the purpose and significance, and stability test results of samples with different size to determine or estimate the value of the expiration date, is our pharmaceutical research and evaluator should be thinking about.
In addition, the stability test of inspection index mainly includes the appearance, physical and chemical properties, chemical properties and microbial properties, etc., so, to what extent these inspection index change is still considered stable, the limit is the key to determine the validity of drugs. The purpose and significance of the stability chamber of different scale samples are given below. How to determine whether the appearance, physicochemical properties, chemical properties and microbial properties of drugs change; How to determine or calculate the expiry date of the drug; As well as the issues to be paid attention to when determining the expiration date of the drug, we will discuss our views and discuss with the people in the industry.

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