ICH, EMA and other guidelines require stability testing of all pharmaceutical ingredients and drug products. BOC Sciences designs protocols for stability studies based on products in different dosage forms to ensure compliance.
The stability of pharmaceutical preparations refers to the speed and degree of quality change in a series of processes from preparation to use, and is one of the important indicators for evaluating the quality of pharmaceutical preparations. Stability studies run through the entire process of drug formulation development, production, and use.
The purpose of the stress testing is to understand the factors affecting the stability of the preparation (high temperature, high humidity, light, acid, alkali, oxidation, etc.) and the possible degradation pathways and degradation products, and to provide reference information for the screening of the preparation process, the selection of packaging materials, and the determination of storage conditions. Generally, three aspects of high temperature, high humidity and light are investigated.
(1) High temperature test
Changes in the quality of the preparations were detected at 60°C. If there is a significant change, perform the test again at 40°C.
(2) High humidity test
The preparation is placed in a constant humidity closed container, and the test is carried out under the conditions of a temperature of 25°C and a relative humidity of 90%±5%. If the quality of the preparation has changed significantly, reduce the corresponding test conditions.
(3) Light stability test
The formulation should be fully exposed for photostability testing. The test was continued until the formulation and its packaging were sufficiently resistant to light.
Fig. 1 Light stability test process
Under the condition of higher temperature and humidity than long-term storage, the stability of the preparation is investigated to provide a basis for the design of the formulation process and whether the preparation can still maintain stable quality even if it deviates from the actual storage conditions, and based on the test results to determine whether intermediate Stability tests under conditions and to determine placement conditions for long-term tests.
Three batches of preparation samples are required, and they are packaged in the market and placed for 6 months at a temperature of 40±2°C and a relative humidity of 75±5%. Under the above conditions, if the sample of the preparation fails to meet the quality standard within 6 months, the accelerated test shall be carried out under the intermediate conditions, that is, the temperature is 30±2°C and the relative humidity is 60±5%, and the time is still 6 months.
For preparation products, long-term stability studies are carried out under expected storage conditions, and short-term studies are carried out at higher temperatures to investigate their stability during transportation, storage, and use, and provide data support for confirming storage conditions and shelf life. The inspection time is consistent with the shelf life. Our experienced staff will ensure that stability studies are performed under conditions suitable for your biological product.
As a leading service provider in the life sciences, BOC Sciences provides your pharmaceutical ingredients or drug products with proof of their stability and quality under various conditions. With our state-of-the-art laboratories, we can provide you with project-appropriate stability studies to ensure your regulatory approval.