Usp 797 Traduccion.docx

〈 7 9 7 〉 P H A R M A C E U T I C A L C O M P O U N D I N G — STERILEPREPARATIONS INTRODUCTION The objective of this chapteris to d e s c r i b e c o n d i t i o n s a n d p r a c t i c e s t opreventharm,includingdeath,topatientsthatcouldresultfrom(1) microbialcontamination(nonsterility),(2)excessivebacterialendot oxins,(3)variabilityintheintendedstrengthofcorrectingredientsth atexceedseithermonographlimitsforofficialarticles(see“official” and“article”intheGeneralNoticesandRequirements)or10%fornono fficialarticles,(4)unintendedchemicalandphysicalcontaminants,a nd(5)ingredientsofinappropriatequalityincompoundedsterileprep arations(CSPs).ContaminatedCSPsarepotentiallymosthazardousto patientswhenadministeredintobodycavities,centralnervousandva scularsystems,eyes,andjoints,andwhenusedasbathsforliveorgans andtissues.WhenCSPscontainexcessivebacterialendotoxins(seeBa cterialEndotoxinsTest〈85〉),theyarepotentiallymosthazardoustop atientswhenadministeredintothecentralnervoussystem.Despiteth eextensiveattentioninthischaptertotheprovision,maintenance, andeval u a t i o n o f a i r q u a l i t y , t h e a v o i d a n c e o f d i r e c t o r p h y