DESCRIPTION

Glass containers for pharmaceutical use are intended to come into direct contact with pharmaceutical products. The following recommendations can be made as to the suitability of a glass container for pharmaceutical products, based on the tests for hydrolytic resistance. Glass containers meeting Type I performance are suitable for most products for parenteral and nonparenteral uses (e.g., borosilicate). Glass containers meeting Type II performance are suitable for most acidic and neutral aqueous products for parenteral and nonparenteral uses (e.g., treated soda-lime silica). Glass containers meeting Type II performance may be used for alkaline parenteral products where stability data demonstrate their suitability. Glass containers meeting Type III performance (e.g., soda-lime silica) usually are not used for parenteral products or for powders for parenteral use, except where suitable stability test data indicate that containers meeting Type III performance are satisfactory.