{"id":9852,"date":"2026-02-24T15:11:45","date_gmt":"2026-02-24T07:11:45","guid":{"rendered":"https:\/\/www.packqc.com\/standard\/usp-1217\/"},"modified":"2026-04-16T09:59:54","modified_gmt":"2026-04-16T01:59:54","slug":"usp-1217","status":"publish","type":"standard","link":"https:\/\/www.packqc.com\/cs\/standard\/usp-1217\/","title":{"rendered":"USP"},"content":{"rendered":"<h2 class=\"wp-block-heading\">Z\u00e1kladn\u00ed testy podle USP 1217<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Zkou\u0161ka tvrdosti tablet a l\u00e1mac\u00ed s\u00edly<\/h3>\n\n\n\n<p>\u010casto myln\u011b ch\u00e1pan\u00e1 jako povrchov\u00e1 tvrdost. <strong data-start=\"2103\" data-end=\"2127\">zkou\u0161ka tvrdosti tablet<\/strong> v norm\u011b USP ve skute\u010dnosti odkazuje na <strong data-start=\"2165\" data-end=\"2183\">zlomov\u00e1 s\u00edla<\/strong>-tlak pot\u0159ebn\u00fd k tomu, aby do\u0161lo k rozlomen\u00ed tablety. Jedn\u00e1 se o kl\u00ed\u010dov\u00fd ukazatel pevnosti v tahu a celistvosti p\u0159i lisov\u00e1n\u00ed. Zkou\u0161ka se obvykle prov\u00e1d\u00ed pomoc\u00ed automatick\u00fdch tester\u016f, jako je nap\u0159. <a href=\"https:\/\/www.celtec.cn\/newsinfo\/7623506.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"2373\" data-end=\"2406\">MPT-02 Tester tvrdosti tablet<\/strong><\/a> z Cell Instruments, kter\u00fd zaji\u0161\u0165uje konzistentn\u00ed m\u00edru zat\u00ed\u017een\u00ed a p\u0159esn\u00e9 pou\u017eit\u00ed s\u00edly.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Zkou\u0161ka komprese<\/h3>\n\n\n\n<p>The <strong data-start=\"2530\" data-end=\"2550\">kompresn\u00ed zkou\u0161ka<\/strong> zahrnuje pr\u016fm\u011brn\u00e9 nakl\u00e1d\u00e1n\u00ed tablet, zejm\u00e9na kulat\u00fdch tablet. S\u00edla p\u016fsob\u00ed mezi dv\u011bma deskami, dokud se tableta nerozlom\u00ed. Pro speci\u00e1ln\u00ed tvary nebo r\u00fdhovan\u00e9 tablety se pou\u017e\u00edvaj\u00ed alternativn\u00ed metody, nap\u0159. <strong data-start=\"2750\" data-end=\"2779\">t\u0159\u00edbodov\u00e9 ohybov\u00e9 zkou\u0161ky<\/strong> se doporu\u010duje. Str\u00e1nky <strong data-start=\"2801\" data-end=\"2820\">rychlost nakl\u00e1d\u00e1n\u00ed<\/strong>, rovnob\u011b\u017enost desek a p\u0159esnost kalibrace p\u0159\u00edmo ovliv\u0148uj\u00ed spolehlivost testu.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Zkou\u0161ka k\u0159ehkosti (podle USP)<\/h3>\n\n\n\n<p>Zat\u00edmco USP  klade d\u016fraz na l\u00e1mavost, zkou\u0161en\u00ed drobivosti je zahrnuto v USP . Tato zkou\u0161ka simuluje drcen\u00ed tablet v rotuj\u00edc\u00edm bubnu za \u00fa\u010delem stanoven\u00ed <strong data-start=\"3107\" data-end=\"3129\">&nbsp;k\u0159ehkost<\/strong> a <strong data-start=\"3134\" data-end=\"3157\">odolnost proti od\u011bru<\/strong>. \u00dabytek hmotnosti po p\u0159evr\u00e1cen\u00ed ur\u010duje drobivost. P\u0159ijateln\u00fd \u00fabytek hmotnosti je obvykle \u22641%. Tato zkou\u0161ka dopl\u0148uje zkou\u0161ku tvrdosti t\u00edm, \u017ee odhaluje, jak tablety obstoj\u00ed p\u0159i dynamick\u00e9m mechanick\u00e9m nam\u00e1h\u00e1n\u00ed.<\/p>\n\n\n\n<figure class=\"wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio\"><div class=\"wp-block-embed__wrapper\">\n<div class=\"ast-oembed-container\" style=\"height: 100%;\"><iframe title=\"Zkou\u0161ka tvrdosti tablet Zkou\u0161ka tvrdosti v tlaku pro tablety l\u00e9k\u016f\" width=\"500\" height=\"281\" src=\"https:\/\/www.youtube.com\/embed\/uYgafVVSvpY?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen><\/iframe><\/div>\n<\/div><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">Pochopen\u00ed USP 1217 a jej\u00edho v\u00fdznamu<\/h2>\n\n\n\n<p>USP  uv\u00e1d\u00ed postupy pro hodnocen\u00ed <strong data-start=\"1294\" data-end=\"1313\">s\u00edla tablet<\/strong>, se zam\u011b\u0159en\u00edm na mechanick\u00e9 vlastnosti, jako jsou <strong data-start=\"1357\" data-end=\"1375\">zlomov\u00e1 s\u00edla<\/strong>, <strong data-start=\"1377\" data-end=\"1398\">pevnost v tlaku<\/strong>a <strong data-start=\"1404\" data-end=\"1424\">pevnost v tahu<\/strong>. Tyto parametry maj\u00ed z\u00e1sadn\u00ed v\u00fdznam pro zaji\u0161t\u011bn\u00ed zachov\u00e1n\u00ed struktur\u00e1ln\u00ed integrity tablet a\u017e do okam\u017eiku, kdy se dostanou ke spot\u0159ebiteli. Norma podporuje konzistentn\u00ed postupy testov\u00e1n\u00ed nap\u0159\u00ed\u010d pr\u016fmyslov\u00fdmi odv\u011btv\u00edmi, od farmaceutick\u00fdch v\u00fdrobk\u016f a\u017e po dopl\u0148ky stravy.<\/p>\n\n\n\n<p>P\u0159i zkou\u0161ce na poru\u0161en\u00ed, jak je definov\u00e1na v t\u00e9to norm\u011b, se pou\u017e\u00edvaj\u00ed p\u0159esn\u00e9 mechanick\u00e9 nebo motorizovan\u00e9 zkou\u0161e\u010dky, kter\u00e9 p\u016fsob\u00ed na tablety tlakov\u00fdm zat\u00ed\u017een\u00edm, dokud nedojde k lomu. Tato m\u011b\u0159en\u00ed slou\u017e\u00ed jako vod\u00edtko p\u0159i v\u00fdvoji v\u00fdrobku a zaji\u0161\u0165uj\u00ed <strong data-start=\"1874\" data-end=\"1893\">kontrola kvality<\/strong> identifikac\u00ed potenci\u00e1ln\u00edch nedostatk\u016f ve slo\u017een\u00ed nebo v\u00fdrob\u011b.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Zkou\u0161ka ohybu ve t\u0159ech bodech pro speci\u00e1ln\u00ed tvary tablet<\/h2>\n\n\n\n<p>Ploch\u00e9 tablety nebo tablety ve tvaru tobolky se nemus\u00ed p\u0159i lisov\u00e1n\u00ed d\u016fsledn\u011b l\u00e1mat. V takov\u00fdch p\u0159\u00edpadech se <strong data-start=\"3518\" data-end=\"3546\">t\u0159\u00edbodov\u00e1 zkou\u0161ka ohybem<\/strong> poskytuje lep\u0161\u00ed posouzen\u00ed <strong data-start=\"3579\" data-end=\"3604\">l\u00e1mac\u00ed s\u00edla tablet<\/strong> a odolnost vnit\u0159n\u00ed struktury. Tato sestava podp\u00edr\u00e1 tablety na obou konc\u00edch a p\u016fsob\u00ed na n\u011b p\u0159etr\u017een\u00edm v polovin\u011b, \u010d\u00edm\u017e poskytuje p\u0159esn\u00e9 \u00fadaje o pevnosti v tahu, kter\u00e9 jsou u\u017eite\u010dn\u00e9 zejm\u00e9na v n\u00e1sleduj\u00edc\u00edch p\u0159\u00edpadech <strong data-start=\"3790\" data-end=\"3817\">zkou\u0161ka l\u00e1mavosti tablet<\/strong> hodnocen\u00ed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Anal\u00fdza k\u0159ehkosti a pevnosti tablet v tahu<\/h2>\n\n\n\n<p>K\u0159ehk\u00e9 tablety jsou n\u00e1chyln\u011bj\u0161\u00ed k od\u0161t\u00edpnut\u00ed, prasknut\u00ed nebo rozbit\u00ed p\u0159i manipulaci. Norma USP doporu\u010duje po\u010d\u00edtat <strong data-start=\"4009\" data-end=\"4029\">pevnost v tahu<\/strong> na z\u00e1klad\u011b l\u00e1mac\u00ed s\u00edly, pr\u016fm\u011bru a tlou\u0161\u0165ky tablety. Tato anal\u00fdza je obzvl\u00e1\u0161t\u011b u\u017eite\u010dn\u00e1 pro porovn\u00e1n\u00ed r\u016fzn\u00fdch formulac\u00ed a zaji\u0161t\u011bn\u00ed rovnom\u011brnosti d\u00e1vkov\u00e1n\u00ed.<\/p>\n\n\n\n<p>Modern\u00ed testery, jako nap\u0159. <strong data-start=\"4225\" data-end=\"4258\">MPT-02 Tester tvrdosti tablet<\/strong>, nab\u00edzej\u00ed programovateln\u00e9 rychlosti zat\u00ed\u017een\u00ed, konzistentn\u00ed \u0159\u00edzen\u00ed posunu a digit\u00e1ln\u00ed ode\u010dty s vysok\u00fdm rozli\u0161en\u00edm, kter\u00e9 podporuj\u00ed p\u0159esn\u00fd sb\u011br dat v tahu a tlaku.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">V\u00fdb\u011br spr\u00e1vn\u00e9ho testeru tvrdosti tablet<\/h2>\n\n\n\n<p>Aby byly spln\u011bny po\u017eadavky na v\u00fdkon podle USP  , mus\u00ed testery poskytnout:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Rovnob\u011b\u017en\u00e9, p\u0159esn\u011b brou\u0161en\u00e9 desky<\/strong><\/li>\n\n\n\n<li><strong>Konstantn\u00ed rychlost nakl\u00e1d\u00e1n\u00ed nebo pohybu desky<\/strong><\/li>\n\n\n\n<li><strong>P\u0159esn\u00e9 m\u011b\u0159en\u00ed s\u00edly v newtonech<\/strong><\/li>\n\n\n\n<li><strong>Mo\u017enost z\u00e1znamu dat a kalibrace v re\u00e1ln\u00e9m \u010dase<\/strong><\/li>\n<\/ul>\n\n\n\n<p><strong data-start=\"4752\" data-end=\"4780\">Cell Instruments\u2019 MPT-02<\/strong> je pro tyto aplikace speci\u00e1ln\u011b navr\u017een. D\u00edky digit\u00e1ln\u00edm sn\u00edma\u010d\u016fm zat\u00ed\u017een\u00ed, programovateln\u00fdm zku\u0161ebn\u00edm parametr\u016fm a souladu s mezin\u00e1rodn\u00edmi normami je ide\u00e1ln\u00ed pro v\u00fdzkum a v\u00fdvoj a rutinn\u00ed zkou\u0161ky. <strong data-start=\"4952\" data-end=\"4971\">s\u00edla tablet<\/strong> ov\u011b\u0159en\u00ed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Veden\u00ed testov\u00e1n\u00ed s d\u016fv\u011brou <\/h2>\n\n\n\n<p>Pochopen\u00ed a pou\u017eit\u00ed <a href=\"https:\/\/www.uspnf.com\/notices\/general-chapter-prospectus-tablet-breaking-force-1217\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">USP<\/a> \u00a0zaji\u0161\u0165uje, \u017ee tablety spl\u0148uj\u00ed celosv\u011btov\u00e9 standardy mechanick\u00e9 pevnosti. A\u0165 u\u017e prov\u00e1d\u00edte <strong data-start=\"5181\" data-end=\"5205\">zkou\u0161ka tvrdosti tablet<\/strong>, <strong data-start=\"5207\" data-end=\"5227\">kompresn\u00ed zkou\u0161ka<\/strong>, <strong data-start=\"5229\" data-end=\"5248\">zkou\u0161ka drobivosti<\/strong>, nebo vyhodnocov\u00e1n\u00ed <strong data-start=\"5264\" data-end=\"5286\">k\u0159ehkost tablet<\/strong>, dodr\u017eov\u00e1n\u00ed tohoto r\u00e1mce zlep\u0161uje kvalitu v\u00fdrobk\u016f, sni\u017euje po\u010det selh\u00e1n\u00ed a podporuje dodr\u017eov\u00e1n\u00ed p\u0159edpis\u016f.<\/p>\n\n\n\n<p><strong data-start=\"5394\" data-end=\"5424\">Bun\u011b\u010dn\u00e9 n\u00e1stroje <\/strong>podporuje profesion\u00e1ly ve farmaceutick\u00e9m, potravin\u00e1\u0159sk\u00e9m a obalov\u00e9m pr\u016fmyslu \u0161pi\u010dkov\u00fdmi \u0159e\u0161en\u00edmi, jako je nap\u0159\u00edklad<a href=\"https:\/\/www.packqc.com\/cs\/tablet-hardness-tester\/\" target=\"_blank\" rel=\"noopener\"> <strong data-start=\"5535\" data-end=\"5568\">MPT-02 Tester tvrdosti tablet<\/strong><\/a>, co\u017e umo\u017e\u0148uje p\u0159esn\u00e9, reprodukovateln\u00e9 a standard\u016fm vyhovuj\u00edc\u00ed testov\u00e1n\u00ed ve v\u0161ech oblastech.<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Essential Tests Covered by USP 1217 Tablet Hardness Test and Breaking Force Often misunderstood as surface hardness, the tablet hardness test in USP standard actually refers to the breaking force\u2014the pressure needed to cause the tablet to fracture. This is a key indicator of tensile strength and compression integrity. The test is typically conducted using [&hellip;]<\/p>","protected":false},"featured_media":7251,"parent":0,"template":"","meta":{"_acf_changed":true,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}}},"standard-category":[616],"class_list":["post-9852","standard","type-standard","status-publish","has-post-thumbnail","hentry","standard-category-usp"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/standard\/9852","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/media\/7251"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/media?parent=9852"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/standard-category?post=9852"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}