Transcription of h671i CONTAINERS— PERFORMANCE TESTING - USP-NF
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h671i CONTAINERS— PERFORMANCE TESTING - USP-NF
&h671iCONTAINERS PERFORMANCE TESTINGIt is the purpose of this chapter to provide standards for the func-tional properties of plastic containers and their components used topackage regulated articles (pharmaceuticals, biologics, dietary sup-plements, and devices). Definitions that apply to this chapter areprovided in thePreservation, Packaging, Storage, and Labelingsection of theGeneral Notices and Requirements. The tests thatfollow are provided to determine the moisture permeability andlight transmission of plastic containers utilized for regulated arti-cles. The sectionMultiple-Unit Containers for Capsules and Tab-letsapplies to multiple-unit containers. The sectionSingle-UnitContainers and Unit-Dose Containers for Capsules and Tabletsapplies to single-unit and unit-dose containers.
Desiccant—Place a quantity of 4- to 8-mesh, anhydrous calci-umchloride1 inashallowcontainer,takingcaretoexcludeanyfine powder, then dry at 1108 for 1 hour, and cool in a desiccator. Procedure —Select 12 containers of a uniform size and type, clean the sealing surfaces with a lint-free cloth, and close and open each container 30 times.
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