Pharmaceutical packaging materials are an indispensable link and element in the development and production of pharmaceuticals. In addition to protecting the active components or preparations from external interference, in order to protect their efficacy, they should also have a good phase with the active components or preparations. Capacitance, that is, the introduction of leachables that may cause safety problems, or the level of their extracts must not exceed the safe range. Therefore, compatibility with drugs is one of the basic characteristics that pharmaceutical packaging materials must possess. Compatibility testing is also a must-test. Specifically, it refers to whether migration or adsorption occurs between drug packaging materials and drugs. An experiment that affects the quality of the drug.
Due to the large number of packaging materials, the different packaging containers and the different packaged preparations, CFDA issued the “Guidelines for Pharmaceutical Packaging Materials and Drug Compatibility Testing†(Standard No. YBB00142002) for convenient and effective testing. -2015). It specifies the test conditions for the compatibility test to predict the effectiveness of the package for drug protection and to estimate the expiration date of the drug.
1. Light test · For most drug packaging materials, strong light irradiation test should be carried out. The illuminance was placed at 4,500 lx ± 500 lx for 10 days.
2. Accelerated test • Place the test sample at a temperature of 40 ° C ± 2 ° C and a relative humidity of 90% ± 10% or 20% ± 5% for 6 months.
· Temperature-sensitive drugs can be placed for 6 months at a temperature of 25 ° C ± 2 ° C and a relative humidity of 60% ± 10%.
· For drugs packed in semi-permeable containers, the test should be carried out at a temperature of 40 ° C ± 2 ° C and a relative humidity of 25 ± 5%.
3. Long-term test · Place the test sample in a constant temperature and humidity chamber with a temperature of 25±2°C and a relative humidity of 60%±10% for 12 months.
· After the long-term trial is completed, it is still necessary to continue to investigate according to the relevant regulations for a period of 36 months to determine the impact of packaging on the drug's expiration date.
4. Special requirements · For liquid containers such as eye drops, injections, suspensions, etc., and solid preparations made of aluminum-plastic blister, the test specimens are placed at a temperature of 25 °C ± 2 °C and a relative humidity of 20% ± Place at 5% or temperature 25 ° C ± 2 ° C, relative humidity 90% ± 10%.
Memmert's full range of constant temperature and humidity products provide a complete solution to the above criteria. The ICHL light stability test box can assist in the completion of the light test, which can be expanded into double-layer illumination to increase the batch throughput. The HPP semiconductor constant temperature and humidity chamber can be fully covered with a wide temperature and humidity range and superior long-term stability. All other test conditions, especially the temperature of 40 ° C ± 2 ° C, relative humidity of 25 ± 5% test conditions; ICH compressor constant temperature and humidity box can also complete most of the tests.
Main technical parameters of Memmert HPP constant temperature and humidity chamber
Temperature range 0-70 ° C
Humidity range 10-90% RH
Semiconductor heating and cooling, energy saving, carbon reduction, environmental protection, low noise, water consumption, 2.5L, 2-3 months (25, 60% RH)
Main technical parameters of Memmert ICHL light stability test box
Temperature range 0-60 ° C
Humidity range 10-80% RH
Light intensity up to 8000 lux
Less than 2.5L of water can be used for 2-3 months (25, 60% RH)
At the same time, it is necessary to refer to the "Technical Guidelines for the Compatibility of Chemical Injection and Pharmaceutical Glass Packaging Containers (Trial)" and other related technologies to know the principles during the test.
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