METHODS FOR DETERMINING CHEMICAL HETEROGENEITY OF GLASS CONTAINERS

    公开(公告)号:US20210080448A1

    公开(公告)日:2021-03-18

    申请号:US17104234

    申请日:2020-11-25

    Abstract: A method of making a glass container for storing a pharmaceutical formulation includes heating a Type 1 glass composition according to ASTM Standard E438-92 (2011) to form a glass melt, and forming the glass melt into a glass tube. The glass tube is then re-formed into the glass container having a glass body with: a wall region with an interior surface and an exterior surface; a heel region; and a base region. The interior surface of the glass container is formed by the interior surface of the glass body. A glass pharmaceutical container has a CDR value of less than or equal to 6.0, at least a class A2 base resistance or better according to ISO 695, at least a type HGB2 hydrolytic resistance or better according to ISO 719, and Type 1 chemical durability according to USP .

    METHODS FOR DETERMINING CHEMICAL HETEROGENEITY OF GLASS CONTAINERS

    公开(公告)号:US20180100846A1

    公开(公告)日:2018-04-12

    申请号:US15782707

    申请日:2017-10-12

    CPC classification number: G01N33/386 A61J1/1468 C03C15/00 G01N1/32 G01N17/00

    Abstract: A method including obtaining glass containers, and adding a solvent to 5.0% by volume to less than or equal to 50.0% by volume. Heating to an elevated temperature and cooling to room temperature. The solvent is consolidated and titrated, where an amount of a titrant is an as received titrant volume. Glass containers are etched, and a second solvent is added at 8.0% by volume to less than or equal to 25.0% by volume. The containers are heated to an elevated temperature and cooled to room temperature. The second solvent is consolidated and titrated, where an amount of a titrant is an etched titrant volume. The Chemical Durability Ratio (CDR) of the plurality of glass containers is calculated where: CDR = As   Received   Titrant   Volume Etched   Titrant   Volume .

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