The eye drop bottle is a container used to store liquid medicine for the eye, and is generally made of low-density polyethylene. In view of the differences between domestic and foreign standards for eye drop bottles, this article mainly discusses the differences between domestic and foreign standards in identifying items.
The identifying items of eye drop bottles include infrared spectroscopy and density. Compared with the United States Pharmacopoeia, China's "Low Density Polyethylene Medical Eye Drop Bottles" quality standard does not include the highly specific differential scanning calorimetry. Method (DSC). Analyze and compare the melting peak and melting curve of samples and pellets by DSC method, which can investigate the consistency of raw materials and product materials.
Infrared spectroscopy inspection, as the main method of identification of pharmaceutical packaging materials, can quickly determine the material of the product and prevent the product formula from being changed at will, but it cannot effectively distinguish low density polyethylene from linear low density polyethylene. The European Pharmacopoeia stipulates that the infrared characteristic absorption peaks of polyethylene (without additives) are 2920, 2850, 1465, 730, 720 cm-1, and the infrared characteristic absorption peaks of polyethylene (with additives) are 2920, 2850, 1465, 1375, 1170, 730, 720cm-1, and the YBB00062002 standard of "Low Density Polyethylene Medical Eye Drop Bottle" promulgated by the State Food and Drug Administration only stipulates that it is basically consistent with the control map.
Density is a physical property constant, which has a certain identification effect on the purity of the material and the formula. The density ranges specified by the US Pharmacopoeia and the European Pharmacopoeia are too broad. In contrast, the density range of eye drop bottles in the Chinese Pharmaceutical Packaging Standard is more reasonable.
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