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What are the technical requirements for medicinal plastic bottles?

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What are the technical requirements for medicinal plastic bottles?

2019-07-29
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The technical requirements for medicinal plastic bottles are introduced by medicinal plastic bottle manufacturers:


1. Appearance quality of medicinal plastic bottles: Oral solid medicinal bottles are generally white. Oral liquid medicinal bottles are generally brown or transparent. They can also produce other color products according to customers' requirements. The color should be uniform and uniform, no obvious color difference, the surface should be smooth and flat, no obvious deformation and scratches are allowed, no sand holes are allowed. Oil stains, air bubbles, the mouth of the bottle should be smooth and smooth.


2, identification

(1) Infrared spectroscopy: The infrared spectrum of the material used in the product should be consistent with the control spectrum.


(2) Density: The density of medicinal plastic bottles is: oral solid and liquid high-density polyethylene bottles should be 0.935 ~ 0.965 (g / cm3) oral solid and liquid polypropylene bottles should be 0.900 ~ 0.915 (g / cm3) orally Solid and liquid polyester bottles should be 1.31 to 1.38 (g/cm3)



3, sealing: vacuum to 27KPa, for 2 minutes, no water or bubbling in the bottle.


4. Water vapor transmission: According to the test conditions, the weight loss of liquid pharmaceutical plastic bottles should not exceed 0.2%: according to the test conditions, the amount of water vapor permeation of solid pharmaceutical plastic bottles should not exceed 1000mg/24h/L.


5, anti-fall: according to the test conditions, naturally fall to a horizontal rigid smooth surface, can not be broken, this test is limited to oral liquid pharmaceutical plastic bottles.


6. Oscillation test: This test is limited to oral solid pharmaceutical plastic bottles and should be qualified according to the test conditions.


7. Residue on ignition: According to the test method (Appendix VIIIN of the Second Edition of the Pharmacopoeia of the People's Republic of China 2000), the residual residue shall not exceed 0.1% (the residue of the bottle containing sunscreen shall not exceed 3.0%).


8. Acetaldehyde: According to the gas chromatography (People's Republic of China Pharmacopoeia 2000 edition two appendix VE), acetaldehyde should not exceed two tenths of a million, this test is limited to medicinal polyester plastic bottles.


9. Dissolution test: Prepare the dissolution test solution according to the standard requirements. Oral liquid pharmaceutical plastic bottle shall test the solution clarity, heavy metal, pH change value, UV absorbance, easy oxide and non-volatile matter. The result should be consistent with Standard requirements; oral solid pharmaceutical plastic bottles are only tested for easy oxides, heavy metals, non-volatiles, and the results should also meet the requirements of the standard.


1O, decolorization test: The coloring bottle should be tested according to the standard requirements, and the color of the soaking liquid should not be applied to the blank liquid.


11. Microbial limit: According to the requirements of the standard and the microbial limit method (the Pharmacopoeia of the People's Republic of China, 2000 edition, Appendix II, XIJ1, oral liquid pharmaceutical plastic bottles, bacteria, mold, yeast, no more than 100 bottles per bottle, E. coli can not be detected The number of bacteria in oral solid medicinal plastic bottles shall not exceed 1000 per bottle, and mold and yeast shall not exceed 100 per bottle. E. coli shall not be detected.


12. Abnormal toxicity: The test shall be carried out according to the standards and according to the law (Appendix XIC of the Second Edition of the Pharmacopoeia of the People's Republic of China, 2000). The above items shall be carried out according to the inspection rules stipulated by the standard. The caps matched with the bottle body may be selected according to the needs of different materials, tested according to the standard dissolution test and abnormal poisonous sputum project, and shall comply with the provisions under relevant items. The project shall be tested and shall comply with the provisions of the relevant items.

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