The stability of drugs refers to the ability of APIs and preparations to maintain their physical, chemical, biological and microbiological properties. The purpose of the stability study is to investigate the law of the nature of the drug substance or preparation that changes with time under the influence of temperature, humidity, light and other conditions, and to provide a scientific basis for the determination of the production, packaging, storage, transportation conditions and expiration date of the drug to ensure Clinical medication is safe and effective.
Stability research is one of the main contents of drug quality control research, and is closely related to drug quality research and the establishment of quality standards. Stability research has a phased characteristic, which runs through the entire process of drug research and development. It generally starts from the preclinical research of drugs. Stability research should continue during the clinical research of drugs and after marketing.
The stability test requires that it be conducted under certain temperature, humidity, and light conditions. The setting of these storage conditions should fully consider the environmental factors that may be encountered during the storage, transportation, and use of drugs.
Test methods for stability studies
According to different research purposes, the content of stability research can be divided into long-term test, accelerated test, and influencing factor test.
Long-term test
The long-term test is conducted under the storage conditions specified in the marketed drugs. The purpose is to examine the stability of the drugs during transportation, storage, and use. It can directly reflect the stability characteristics of the drugs and is the ultimate basis for determining the expiration date and storage conditions.
Take three batches of samples for testing at 25 ℃ ± 2 ℃, RH60% ± 10%. The sampling time is generally once every 3 months at the end of the first year, once every 6 months at the end of the second year, and once every year thereafter.
The long-term test of temperature-sensitive drugs can be tested at 6 ℃ ± 2 ℃; for the pharmaceutical preparations packaged in semi-permeable containers, the long-term test should be under the conditions of 25 ℃ ± 2 ℃ and RH40% ± 10% The sampling time is the same as above.
The general conditions used in the long-term stability test are based on the international climate zone. The world is divided into four international climate zones: I, II, III, and IV. The temperate zones are mainly the United Kingdom, Northern Europe, Canada, and Russia; the subtropical zone is the United States, Japan, and Western Europe (Portugal-Greece); the dry tropical zone is Iran, Iraq, and Sudan; Wet tropical areas include Brazil, Ghana, Indonesia, Nicaragua, and the Philippines
Among the four climatic zones, for the quality assurance of medicines, the most demanding condition is the fourth climatic zone, which is a high temperature and high humidity environment. China is generally subtropical, and the temperature and humidity conditions recommended for long-term tests are: 25 ℃ ± 2 ℃, 60% RH ± 10% RH
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