Eye drops are a high-risk route of administration. Due to the particularity of the drug site, the safety and controllability of its quality is particularly critical and important. Under certain conditions, certain substances contained in the eye drop bottle will migrate to the content, which is likely to cause a certain reaction. In order to prevent excessive dissolution and affect the quality of the medicine, the non-volatile content in the eye drop bottle should be strictly controlled物内容。 Material content.
The raw material resin and the additives added to ensure the performance of the material are the source of the non-volatile substances in the eye drop bottle. These small non-volatile substances are not static inside the package and are easily dissolved into the pharmaceutical products. Migration, when the eye drops are in a high temperature environment, the dissolution rate and dissolution amount of non-volatile substances will increase, and these dissolved substances are likely to contaminate the packaged drugs.
At present, the test of non-volatile matter in pharmaceutical packaging needs to go through the process of evaporation-drying-cooling-weighing. The specific operation method is as follows: accurately measure 50.0ml each of the test solution and blank solution, and place them in a constant weight evaporating dish. After evaporating to dryness, dry at 105°C to constant weight, the difference between the two should not exceed 5.0mg.
The volatile content in the eye drop bottle is an important factor in determining whether it is suitable for eye drop drugs. Choosing the appropriate packaging according to the specific ingredients of the drug is the best way to ensure the safety and effectiveness of the drug. It is also the deep market for pharmaceutical companies. An effective way to improve brand competitiveness.
Copyright © Shijiazhuang Xinfuda Medical Packaging Co., Ltd. All Rights
MAKE AN ENQUIRY
