Abstract: Non-volatiles in pharmaceutical packaging will be dissolved into pharmaceutical products. In order to prevent the excessive amount of dissolution and affect the quality of pharmaceutical products, the non-volatile content in pharmaceutical packaging should be strictly controlled. In this paper, a non-volatile content in a brand of eye drop package is tested as an example. A test method integrating evaporation, drying, weighing and solution recovery is introduced, and the test principle, equipment C 830 migration amount and The parameters of the non-volatiles analyzer, the scope of application, the test process, etc., provide a reference for enterprises to monitor the non-volatile content of pharmaceutical packaging simply and effectively.
Key words: non-volatiles, migration and non-volatiles analyzer, pharmaceutical packaging, eye drop packaging, dissolution, evaporation, drying, weighing
1, meaning
The raw material resin and additives added to ensure the performance of the material are all sources of non-volatile substances in the pharmaceutical packaging. These non-volatile small molecular substances are not static inside the package, and are easily dissolved and transported into the pharmaceutical product. When the packaged product is a liquid medicament or in a high temperature environment, the dissolution rate and dissolution amount of the non-volatile matter are increased, and the dissolved substances are likely to contaminate the packaged medicine. At present, the testing of non-volatiles in pharmaceutical packaging requires an evaporation-drying-cooling-weighing process. The traditional test method is to evaporate the test solution containing the eluate in a water bath, then manually transfer it to an oven for drying, and then transfer. Cooling to the dryer, and finally weighing with the balance, the test process is cumbersome, and human and environmental factors interfere with the test. The new non-volatile matter integration test method described in this paper overcomes the above shortcomings of the traditional test method, realizes the complete automation of the evaporation-drying-cooling-weighing process, and has the function of soaking liquid recovery.
2, test samples
The test sample used in this test is a plastic bottle for packaging a brand of eye drops.
3. Test basis
This test was carried out according to the pharmaceutical packaging standard YBB00072002-2015 "Polypropylene Pharmaceutical Eye Dropper Bottle".
4, test equipment
The test equipment used in this test is C migration and non-volatiles analyzer, which is independently developed and produced by Jinan Languang Electromechanical Technology Co., Ltd.
Figure 1 C 830 migration and non-volatiles analyzer
4.1 Principle of the test
Select the simulant packaging material similar to the nature of the packaged drug, dissolve the non-volatile matter, and evaporate and dry the test solution and the blank simulant to obtain the remaining residue, and subtract the blank simulant from the weight of the residue in the test solution. The weight of the residue is the non-volatile content of the tested packaging material.
4.2 Equipment parameters
The test range is 0.1 ~ 80,000 mg, the resolution is 0.01 mg; the test temperature range is from room temperature to 130 °C, the temperature control accuracy is ±0.3 °C; the evaporation, drying and weighing are integrated, which can automatically and accurately weigh, the test process No need to participate manually; the volatile reagents can be collected and processed in the airtight system, and the requirements for the laboratory ventilation system are low; the international leading rapid evaporation technology is used to shorten the evaporation time; 9 station design, test The process is independent of each other and the test efficiency is high; through the special design of the constant temperature chamber and the weighing system, the test accuracy of the equipment is greatly improved.
4.3 Scope of application
(1) This equipment is suitable for the determination of non-volatiles in pharmaceutical packaging materials, such as infusion bottles, eye drops bottles, oral liquid bottles made of low density polyethylene, high density polyethylene, polypropylene, polyester, etc. Oral medicine bottle, infusion bag bag and cap thereof, medicinal composite film made of polyethylene, biaxially oriented polypropylene, vacuum aluminum-plated cast polypropylene, polyester, etc., bag, with polyvinyl chloride, low Solid pharmaceutical composite hard sheets made of density polyethylene, polyvinylidene chloride, polyamide, etc., medicinal hoses, gaskets, rubber stoppers, pistons and protective caps.
(2) Suitable for the determination of total migration of food contact materials and products, such as polyethylene, polystyrene, polyvinyl chloride, polypropylene, melamine, expanded polystyrene, plant fiber moldings, rubber gaskets (rings) ), pressure cooker seal ring, rubber nipple, rubber tube and other rubber products, food containers such as perchloroethylene, epoxy phenolic, polyamide epoxy resin, polytetrafluoroethylene and other interior coatings.
(3) Meet GB 31604.8-2016, GB 9740-2003, ISO 759-1981, YBB00342002-2015, YBB00132002-2015 and other related pharmaceutical packaging materials standards.
5, the test process
(1) Sampling the flat portion of the plastic bottle sample from the eye drops to ensure that the inner surface area of ​​the sample is 300 cm2, cut into small pieces of 3 cm × 0.3 cm, place in a conical flask, and add 75 mL of distilled water to shake the test clearly. After the washing liquid was removed, it was dried at 30 °C.
(2) Add 100 mL of distilled water to the dried sample, seal and seal, and place at 70 ° C for 24 h.
(3) Take 50 mL of the test solution from the Erlenmeyer flask and place it in a dry and weighed evaporating dish, and take the same volume of distilled water for the blank test.
(4) Place the evaporating dish containing the test solution and distilled water on the tray rack of the migration amount and the corresponding number of the test chamber of the non-volatiles tester, close the test chamber door, set the sample name, reagent evaporation temperature, and test temperature. Test parameters such as test mode and number of tests. The test is initiated and the device volatilizes, dries, and collects the volatile reagents from the evaporating dish.
(5) The equipment is automatically weighed according to the set parameters, and the measured value of the test evaporating dish, the blank evaporating dish and the non-volatile content are measured.
6, test results
The plastic bottle sample for eye drop packaging used in this test had a nonvolatile content of 1.3 mg.
7. Conclusion
The non-volatile content in the package is an important factor in determining whether it is suitable for the packaging of pharmaceutical products. In this paper, the non-volatile content in plastic bottles for eye drops packaging was tested by using a new integrated migration and non-volatiles tester. From the point of view of the test process, the operation of the equipment is simple, the traditional test method is cumbersome to circumvent the test operation, the test time is shortened, the test result is accurate, and the volatile reagent can be sealed and collected, thereby effectively reducing the reagent volatilization zone. The environmental pollution problem and the harm to the test personnel. Jinan Languang Electromechanical Technology Co., Ltd. is a high-tech enterprise specializing in R&D, production and packaging testing services for packaging testing equipment. It is committed to providing customers with accurate, high-end and intelligent testing equipment and rigorous, efficient and intimate testing services. Existing testing equipment includes oxygen, nitrogen, water vapor transmission rate testing equipment, heat seal strength, puncture resistance, peel strength, sealing performance, friction coefficient and other performance testing equipment, to understand the relevant equipment and testing services information, you can log in to view . The more you understand, the more you trust! Labthink is looking forward to enhancing technical communication and cooperation with enterprises and institutions in the industry!
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