Technical requirements for medicinal plastic bottles. M […]
Technical requirements for medicinal plastic bottles. Medicinal plastic bottles are generally made of PE, PP, PET and other materials, which are not easy to break, have good sealing performance, are moisture-proof, hygienic, and meet the special requirements of drug packaging. They can be directly used for drug packaging without cleaning and drying. An excellent pharmaceutical packaging container, widely used in the packaging of oral solid drugs (such as tablets, capsules, granules, etc.) and oral liquid drugs (such as syrups, tinctures, etc.), and other plastic hollow packaging containers Compared with medicinal plastic bottles, there are many special places.
1. Appearance quality of medicinal Rhinitis Spray plastic bottles: Oral solid medicinal bottles are generally white.
Oral liquid medicinal bottles are generally brown or transparent, and other color products can also be produced according to customer requirements. The color should be uniform and there should be no obvious color difference. Oil stains, air bubbles, the bottle mouth should be flat and smooth.
2. Identification (1) Infrared spectrum: 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) Oral Solid and liquid polyester bottles should be 1.31 ~ 1.38 (g/cm³)
3. Airtightness: vacuum to 27KPa for 2 minutes, no water or bubbling in the bottle.
4. Water vapor permeation amount The weight loss of oral liquid medicinal plastic bottle should not exceed 0.2% according to the test conditions: The water vapor permeation amount of oral solid medicinal plastic bottle according to the test conditions should not exceed 1000mg/24h·L.
5. Drop resistance According to the test conditions, it should be naturally dropped to a horizontal rigid and smooth surface without breaking. This test is limited to oral liquid medicinal plastic bottles.
6. Shock test This test is limited to oral solid medicinal plastic bottles, and should be qualified according to the test conditions.
7. Residue on ignition The test is carried out according to the test method (Appendix VIII N of the 2000 edition of the Pharmacopoeia of the People's Republic of China).
8. Acetaldehyde Measured by gas chromatography (Appendix VE, Part II, Pharmacopoeia of the People's Republic of China, 2000 edition), acetaldehyde should not exceed 2/10,000,000. This test is limited to medicinal polyester plastic bottles.
9. Dissolution test Prepare the extractable test solution according to the requirements of the standard, and test the solution clarity, heavy metals, pH change value, UV absorbance, easily oxidized and non-volatile substances in the oral liquid medicinal plastic bottle, and the results should meet the standard. Requirements; Oral solid medicinal plastic bottles are only tested for easy oxides, heavy metals and non-volatile substances, and the results should also meet the requirements of the standard.
10. Decolorization test The coloring bottle shall be tested according to the standard requirements, and the color of the soaking liquid shall not be applied to the blank liquid.
11. The microbial limit is determined according to the requirements of the standard and the microbial limit method (Appendix XIJ1, Part II of the Pharmacopoeia of the People's Republic of China, 2000 edition. The number of bacteria, molds and yeasts in plastic bottles for oral liquid medicine shall not exceed 100 per bottle, and Escherichia coli shall not be detected; The number of bacteria in oral solid medicinal plastic bottles shall not exceed 1000 per bottle, mold and yeast shall not exceed 100 per bottle, and Escherichia coli shall not be detected.