Since the beginning of the 21st century, with the development of science and technology in China, the importance of the pharmaceutical industry (especially drug research and development) has been increasing. Drug development cannot be separated from the experimental stage, which has led to the emergence of a series of products such as drug stability testing chambers (also known as drug investigation chambers or drug property testing chambers).

Evaluating drug stability through drug stability testing chambers can not only improve the effectiveness and safety of drugs in use, but also promote the healthy development of China's pharmaceutical industry to a certain extent. It is an important link and equipment for pharmaceutical research and development and marketization.

Today, we will learn about the main inspection contents of the drug stability test box from several aspects. Why choose this equipment for testing?

1、 Why conduct stability testing on drugs?

The development of drugs is a long-term process, and the ability of drugs to be stored for a long time under different environmental conditions is an important condition for the commercialization of products. The stability assessment of drugs is of utmost importance. If the stability of drugs is poor and degradation occurs, causing quality changes, not only will the efficacy decrease, but the impurities generated may also affect the safety and effectiveness of drug use.

The general changes in medication include the following:

moldy

adhesion

crack

Melt and soften

Odor turns sour

2、 What is stability testing?

Stability of drugs: the ability to maintain their physical, chemical, and biological properties unchanged.

Environmental conditions: temperature, humidity, lighting

In typical objective situations, drugs are generally affected by temperature, humidity, and light, and our drug stability assessment needs to start from these three aspects.

The products produced by Chuangce Technology include drug stability test chambers, drug strong light ultraviolet irradiation test chambers, and comprehensive drug stability test chambers. Customers can choose different product types based on their testing needs.

3、 What are the classifications and contents of stability tests?

① Influencing factor test:

Place the drug under more severe conditions than accelerated testing for stability assessment. Including high temperature test, high humidity test, strong light exposure test, and destructive test.

② Accelerated test:

Stability assessment of drugs under simulated different climatic conditions. The purpose is to accelerate the changes in the physicochemical properties of drugs, explore their stability, and provide necessary basis for formulation design, packaging, transportation, and storage.

③ Long term experiment:

Long term trials are conducted to evaluate the stability of drugs under conditions close to storage, with the aim of providing a basis for determining the expiration date of drugs.

4、 What are the items for stability testing and investigation?

The commonly tested items for active pharmaceutical ingredients include shape, content, etc. On this basis, different dosage forms will have different evaluation criteria.