Application of the Standard for Pharmaceutical Glass Bottles
Various products and different materials form a vertical and horizontal standardization system, which provides sufficient basis and conditions for the selection of scientific, reasonable and suitable glass containers for various drugs. The selection and application of medicinal glass bottles for various types of medicines with different dosage forms, properties and grades should follow the following principles:
chemical stability
Good and suitable chemical stability principle
There should be good compatibility between the glass containers used to hold various medicines and the medicines, that is, to ensure that certain substances between them cannot occur due to the instability of the chemical properties of the glass containers during the production, storage and use of medicines. Variation or failure of medicines due to chemical reactions. For example, high-grade medicines such as blood preparations and vaccines must choose glass containers made of borosilicate glass, and all kinds of strong acid and strong alkali water injection preparations, especially strong alkali water injection preparations, should also use borosilicate glass glass containers. The low borosilicate glass ampoules that are widely used in China are not suitable for holding water injection preparations. This kind of glass material should be gradually transitioned to 5.0 glass material, so as to be in line with international standards as soon as possible to ensure that the medicines it contains will not be used in use. No flakes, no turbidity, no deterioration.
For general powder injections, oral preparations and large infusions, the use of low borosilicate glass or neutralized soda lime glass can still meet the chemical stability requirements. The degree of corrosion of medicines to glass is generally that the liquid is greater than the solid, and the alkalinity is greater than the acidity. In particular, the strong alkali water injection has higher requirements on the chemical properties of medicinal glass bottles.
