Common specifications: 50-500ml

Standard number: YBB00032005-2015

Product registration number: National Medicine Package Word 20170160

Drug packaging material product registration number: B20180001553 (colorless), B20170000358 (brown)

　　1. Glass type

Pure glass is composed of silica with a melting point of about 1700°. Network modifiers such as sodium oxide and potassium oxide or boron oxide are added to lower the melting point, while other network stabilizers like calcium and aluminum oxide are used to enhance the durability of the glass. Colored glass (such as amber glass) is made from transition metal oxides like iron oxide. All additives in the silica glass system can be considered potential extractables in the glass.

The composition of glass does not exist in stoichiometric chemical components but is represented by a range of components. Therefore, there are permissible variations within a type of glass, and the glass types may vary slightly between manufacturers. Soda-lime-silica glass is composed of silica (60%-75%), sodium oxide and potassium oxide (12%-18%), and small amounts of calcium, magnesium, and aluminum oxide (5%-12%). This type of glass has a relatively high coefficient of expansion (COE) and is susceptible to thermal shock damage. Borosilicate glass is composed of silica (70%-80%), boron oxide (7%-13%), and small amounts of sodium, potassium, and aluminum oxides. The presence of boron provides greater resistance to thermal shock and hydrolytic attack. Type I glass has two formulations: 3.3 glass and 5.1 glass.

　2. Classification of molded glass bottles for injection

Pharmaceutical glass containers are glass packaging products used for direct contact with drug formulations. The hydrolytic stability of pharmaceutical glass containers is expressed as the resistance to the release of soluble minerals into water under specified conditions of contact between the container's inner surface or glass particles and water. The resistance to hydrolysis is evaluated by titrating the released alkali. Based on their hydrolytic resistance, glass containers are classified as follows:

Type I glass: Also known as neutral glass, it is a borosilicate glass containing a large amount of boron oxide, which has high water resistance due to the chemical composition of the glass itself. It is suitable for the vast majority of formulations, whether for parenteral (injection) use or not, but the packaging cost is relatively high.

Type II glass: Sodium-lime glass treated with sulfur, which has high hydrolytic resistance due to proper treatment of the glass bottle surface (commonly molded glass bottles abroad, while domestically also applied to low borosilicate tubular products). It is suitable for most acidic and neutral aqueous formulations, regardless of whether they are for parenteral injection.

Type III glass: Sodium-lime glass, which has only moderate hydrolytic resistance (only molded glass bottles). Some factories use amber glass tubes for oral liquid containers. Generally suitable for non-aqueous parenteral formulations, parenteral powders (excluding lyophilized formulations), and non-parenteral formulations.