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USP has released for comment in the January/February edition of Pharmacopeial Forum a revised version of its general chapter <670> on “Auxiliary Packaging Components.” The primary change from the previous version is the addition of a section on desiccants and their test methods – specifically, bentonite, anhydrous calcium chloride, calcium oxide, molecular sieves, and silica gel. Desiccants are used to remove moisture from air in containers in order to protect drug products, particularly solid oral dosage forms. USP also proposes cross referencing <197> on “Spectrophotometric Identification Tests” to allow the techniques to be used as alternative methods for pharmaceutical coil testing. Pharmaceutical coil is used as a filling material in multiple-unit containers for solid oral dosage forms to prevent breakage of tablets or capsules during shipment. The revised chapter is available on the USP website after logging in. Comments are due by March 31, 2016.
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