Oral solid pharmaceutical low-density cap non-volatile test points
The oral solid pharmaceutical low-density polyethylene moisture-proof combination cap mentioned herein refers to an oral solid pharmaceutical plastic bottle cap produced by using low-density polyethylene as a main raw material, and has a silica gel, a macromolecular sieve or a mixed desiccant. A moisture-proof barrier cap with cardboard as a barrier material.
Moisture-proof cover is an important part of oral solid drug packaging materials. As a kind of packaging material that directly contacts drugs, its quality directly affects the safety of drugs and drugs. Therefore, the control of its quality and safety is very important.
In order to improve the performance index of low-density polyethylene against environmental stress cracking and creep resistance, thermal properties, thermal oxygen aging and photo-oxidation aging performance, certain additives and stabilizers will be added during the production process to ensure that the products can meet the requirements. Claim. The use of additives, stabilizers, temperature and environmental influences in the production process, combined with the nature of the material itself, tends to produce a certain amount of material that cannot evaporate or sublimate in its products, which we call non-volatiles.
As a drug contact material, its non-volatile substances are very likely to migrate to the contents, thus affecting the quality of the drug and the safety of the drug. The detection of non-volatiles and the study of drug compatibility have become an increasingly important topic in the field of drug research and development. Therefore, it is particularly important to detect the non-volatile matter of the oral solid pharmaceutical low-density polyethylene moisture-proof combination cap.
Below we will make a combing of the standards and methods for the detection of non-volatiles of oral solid pharmaceutical low-density polyethylene moisture-proof combination caps.
The test equipment that can detect non-volatiles on the market is rare. The reason is that the experimental equipment development is difficult due to the matching of experimental conditions and precision instruments. However, traditional test methods are time consuming, labor intensive, and each process is subject to manual intervention. Furthermore, the detection of non-volatiles can have a more or less effect on the health of the experimenter. Therefore, instrument testing is the only way to help non-volatile detection and material modification of pharmaceutical packaging materials.
Nonvolatiles detection and detection method
Test equipment: Labthink Jinan Languang Electromechanical Technology Co., Ltd. is a new generation of fully automatic high-efficiency C830 migration and non-volatiles analyzer, which can be widely used in the determination of non-volatiles of various pharmaceutical packaging materials. The equipment meets the requirements of the “non-volatile substances†in the pharmaceutical industry GMP standards and the latest version of the 2015 version of the plastic package.
Test procedure: Prepare the test solution, take three parts of the bottle cap cover (divided into 1 cm and 1 cm wide), place them in a conical flask, add water, shake the small pieces, and discard the water. Repeat this operation twice. Soaked in water (70 ° C ± 2 ° C), 65% ethanol (70 ° C ± 2 ° C), n-hexane (58 ° C ± 2 ° C) and the volume of the extract (0.2 g / ml) for 24 hours, remove , let cool to room temperature, and add the original volume to the test solution with the same batch of test solvent. The experiment was carried out with the same batch of water, 65% ethanol and n-hexane as blank liquid.
Separately measure 50.0 ml of water, 65% ethanol, n-hexane test solution and blank solution, respectively, and place them in the instrument. Set C830 migration amount and non-volatiles tester to 105 °C for drying until constant weight. According to the standard YBB00172004-2015, the difference between water non-volatile residue and blank residue should not exceed 12.0mg, the difference between 65% ethanol non-volatile residue and blank residue should not exceed 50.0mg; the difference between n-hexane non-volatile residue and blank residue Do not pass 200.0mg.
Labthink is committed to helping customers cope with new packaging problems and improving the quality and safety of packaging-related industries through the development of packaging inspection technology and the development of sophisticated inspection instruments. For more information, please pay attention to the Labthink Languang WeChat public number "Jinan Languang Packaging Safety Testing Expert".
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