Materials used for containers are described in general chapter 3. General names used for materials, particularly plastics materials, each cover a range of products varying not only in the properties of the principal constituent but also in the additives used. The test methods and limits for materials depend on the formulation and are therefore applicable only for materials whose formulation is covered by the preamble to the specification. The use of materials with different formulations and the test methods and limits applied to them are subject to agreement by the competent authority.
The specifications for containers in general chapter 3 have been developed for general application to containers of the stated category but in view of the wide variety of containers available and possible new developments, the publication of a specification does not exclude the use, in justified circumstances, of containers that comply with other specifications, subject to agreement by the competent authority.
Reference may be made within the monographs of the Pharmacopoeia to the definitions and specifications for containers provided in this section. The general monographs for pharmaceutical dosage forms may, under the heading Definition/Production, require the use of certain types of container; certain other monographs may, under the heading Storage, indicate the type of container that is recommended for use.