USP <381>USP 381 Elastomeric closures for injection
This chapter applies to closures used for long-term storage of preparations defined in the general test chapter Packaging and Storage Requirements á659ñ, Injection Packaging. Such closures are typically used as part of a vial, bottle, or pre-fill syringe package system.
This chapter applies to closures formulated with natural or synthetic elastomeric substances. This chapter does not apply to closures made from silicone elastomer; however, it does apply to closures treated with silicone (e.g, Dimethicone, NF).