Many Pharmacopeial articles are of such nature as to require the greatest attention to the containers in which they are stored or maintained even for short periods of time. While the needs vary widely and some of them are not fully met by the containers available, objective standards are essential. It is the purpose of this chapter to provide such standards as have been developed for the materials of which pharmaceutical containers principally are made, i.e., glass and plastic.
A container intended to provide protection from light or offered as a light-resistant container meets the requirements for Light Transmission, where such protection or resistance is by virtue of the specific properties of the material of which the container is composed, including any coating applied thereto. A clear and colorless or a translucent container that is made light-resistant by means of an opaque enclosure (see General Notices) is exempt from the requirements for Light Transmission.
Containers composed of glass meet the requirements for Chemical ResistanceGlass Containers, and containers composed of plastic and intended for packaging products prepared for parenteral use meet the requirements under Biological TestsPlastics and Physicochemical TestsPlastics.
Where dry oral dosage forms, not meant for constitution into solution, are intended to be packaged in a container defined in the section Polyethylene Containers, the requirements given in that section are to be met.
Guidelines and requirements under Repacking into Single-Unit Containers and Unit-Dose Containers for Nonsterile Solid and Liquid Dosage Forms apply to official dosage forms that are repackaged into single-unit or unit-dose containers or mnemonic packs for dispensing pursuant to prescription.