{"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\/sk\/standard\/usp-1217\/","title":{"rendered":"USP"},"content":{"rendered":"<h2 class=\"wp-block-heading\">Z\u00e1kladn\u00e9 testy, na ktor\u00e9 sa vz\u0165ahuje USP 1217<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Sk\u00fa\u0161ka tvrdosti tabliet a sila l\u00e1mania<\/h3>\n\n\n\n<p>\u010casto nespr\u00e1vne ch\u00e1pan\u00e1 ako povrchov\u00e1 tvrdos\u0165. <strong data-start=\"2103\" data-end=\"2127\">test tvrdosti tabliet<\/strong> v norme USP sa v skuto\u010dnosti vz\u0165ahuje na <strong data-start=\"2165\" data-end=\"2183\">l\u00e1macia sila<\/strong>-tlak potrebn\u00fd na to, aby sa tableta zlomila. Je to k\u013e\u00fa\u010dov\u00fd ukazovate\u013e pevnosti v \u0165ahu a celistvosti pri stla\u010den\u00ed. Test sa zvy\u010dajne vykon\u00e1va pomocou automatick\u00fdch testerov, ako napr. <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 tabliet<\/strong><\/a> od Cell Instruments, ktor\u00fd zabezpe\u010duje konzistentn\u00fa mieru za\u0165a\u017eenia a presn\u00e9 pou\u017eitie sily.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Test kompresie<\/h3>\n\n\n\n<p>The <strong data-start=\"2530\" data-end=\"2550\">kompresn\u00fd test<\/strong> zah\u0155\u0148a priemern\u00e9 nakladanie tabliet, najm\u00e4 okr\u00fahlych tabliet. Sila p\u00f4sob\u00ed medzi dvoma plat\u0148ami, k\u00fdm sa tableta nerozlom\u00ed. V pr\u00edpade \u0161peci\u00e1lnych tvarov alebo delen\u00fdch tabliet sa pou\u017e\u00edvaj\u00fa alternat\u00edvne met\u00f3dy, ako napr. <strong data-start=\"2750\" data-end=\"2779\">trojbodov\u00e9 ohybov\u00e9 sk\u00fa\u0161ky<\/strong> sa odpor\u00fa\u010da. Str\u00e1nka <strong data-start=\"2801\" data-end=\"2820\">miera za\u0165a\u017eenia<\/strong>, rovnobe\u017enos\u0165 platn\u00ed a presnos\u0165 kalibr\u00e1cie priamo ovplyv\u0148uj\u00fa spo\u013eahlivos\u0165 testu.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Sk\u00fa\u0161ka drobivosti (pod\u013ea USP)<\/h3>\n\n\n\n<p>Zatia\u013e \u010do USP  kladie d\u00f4raz na silu l\u00e1mania, testovanie drobivosti je zahrnut\u00e9 v USP . T\u00e1to sk\u00fa\u0161ka simuluje prevracanie tabliet v rotuj\u00facom bubne s cie\u013eom ur\u010di\u0165 <strong data-start=\"3107\" data-end=\"3129\">&nbsp;krehkos\u0165<\/strong> a <strong data-start=\"3134\" data-end=\"3157\">odolnos\u0165 proti oderu<\/strong>. \u00dabytok hmotnosti po prevalen\u00ed ur\u010duje krehkos\u0165. Prijate\u013en\u00e1 strata hmotnosti je zvy\u010dajne \u22641%. Tento test dop\u013a\u0148a test tvrdosti t\u00fdm, \u017ee odha\u013euje, ako tablety odol\u00e1vaj\u00fa dynamick\u00e9mu mechanick\u00e9mu nam\u00e1haniu.<\/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=\"Testovanie tvrdosti tabliet Sk\u00fa\u0161ka tvrdosti v tlaku pre tablety liekov\" 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\">Pochopenie USP 1217 a jeho v\u00fdznamu<\/h2>\n\n\n\n<p>USP  uv\u00e1dza postupy hodnotenia <strong data-start=\"1294\" data-end=\"1313\">sila tablety<\/strong>, so zameran\u00edm na mechanick\u00e9 vlastnosti, ako napr. <strong data-start=\"1357\" data-end=\"1375\">l\u00e1macia sila<\/strong>, <strong data-start=\"1377\" data-end=\"1398\">pevnos\u0165 v tlaku<\/strong>, a <strong data-start=\"1404\" data-end=\"1424\">pevnos\u0165 v \u0165ahu<\/strong>. Tieto parametre s\u00fa rozhoduj\u00face na zabezpe\u010denie toho, aby si tablety zachovali \u0161truktur\u00e1lnu integritu, k\u00fdm sa dostan\u00fa k spotrebite\u013eovi. Norma podporuje konzistentn\u00e9 postupy testovania v r\u00f4znych odvetviach, od farmaceutick\u00e9ho priemyslu a\u017e po v\u00fd\u017eivov\u00e9 doplnky.<\/p>\n\n\n\n<p>Pri sk\u00fa\u0161ke lomovou silou, ako je definovan\u00e1 v tejto norme, sa pou\u017e\u00edvaj\u00fa presn\u00e9 mechanick\u00e9 alebo motorizovan\u00e9 sk\u00fa\u0161obn\u00e9 zariadenia, ktor\u00e9 p\u00f4sobia na tablety tlakov\u00fdm za\u0165a\u017een\u00edm, a\u017e k\u00fdm ned\u00f4jde k lomu. T\u00fdmito meraniami sa riadi v\u00fdvoj v\u00fdrobku a zabezpe\u010duje sa <strong data-start=\"1874\" data-end=\"1893\">kontrola kvality<\/strong> identifikovan\u00edm potenci\u00e1lnych nedostatkov v zlo\u017een\u00ed alebo v\u00fdrobe.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Sk\u00fa\u0161ka trojbodov\u00fdm ohybom pre \u0161peci\u00e1lne tvary tabliet<\/h2>\n\n\n\n<p>Ploch\u00e9 tablety alebo tablety v tvare kaps\u00fal sa nemusia pod tlakom d\u00f4sledne l\u00e1ma\u0165. V tak\u00fdchto pr\u00edpadoch sa <strong data-start=\"3518\" data-end=\"3546\">trojbodov\u00e1 sk\u00fa\u0161ka ohybom<\/strong> poskytuje lep\u0161ie hodnotenie <strong data-start=\"3579\" data-end=\"3604\">sila l\u00e1mania tabliet<\/strong> a odolnos\u0165 vn\u00fatornej \u0161trukt\u00fary. Toto nastavenie podopiera tablety na oboch koncoch a p\u00f4sob\u00ed na ne l\u00e1mavou silou v strede, \u010d\u00edm poskytuje presn\u00e9 \u00fadaje o pevnosti v \u0165ahu, ktor\u00e9 s\u00fa u\u017eito\u010dn\u00e9 najm\u00e4 pri <strong data-start=\"3790\" data-end=\"3817\">test l\u00e1mavosti tabliet<\/strong> hodnotenia.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Anal\u00fdza krehkosti a pevnosti tabliet v \u0165ahu<\/h2>\n\n\n\n<p>Krehk\u00e9 tablety s\u00fa n\u00e1chylnej\u0161ie na od\u0161tiepenie, praskanie alebo l\u00e1manie pri manipul\u00e1cii. Norma USP nab\u00e1da k v\u00fdpo\u010dtu <strong data-start=\"4009\" data-end=\"4029\">pevnos\u0165 v \u0165ahu<\/strong> na z\u00e1klade l\u00e1mavosti, priemeru a hr\u00fabky tablety. T\u00e1to anal\u00fdza je obzvl\u00e1\u0161\u0165 u\u017eito\u010dn\u00e1 na porovn\u00e1vanie r\u00f4znych formul\u00e1ci\u00ed a zabezpe\u010denie rovnomernosti d\u00e1vkovania.<\/p>\n\n\n\n<p>Modern\u00e9 testery, ako napr. <strong data-start=\"4225\" data-end=\"4258\">MPT-02 Tester tvrdosti tabliet<\/strong>, pon\u00fakaj\u00fa programovate\u013en\u00e9 r\u00fdchlosti za\u0165a\u017eovania, d\u00f4sledn\u00fa kontrolu posunu a digit\u00e1lne \u00fadaje s vysok\u00fdm rozl\u00ed\u0161en\u00edm, ktor\u00e9 podporuj\u00fa presn\u00fd zber \u00fadajov v \u0165ahu a tlaku.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">V\u00fdber spr\u00e1vneho testera tvrdosti tabliet<\/h2>\n\n\n\n<p>Na splnenie po\u017eiadaviek na v\u00fdkon pod\u013ea USP  musia testery poskytn\u00fa\u0165:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Rovnobe\u017en\u00e9, presne br\u00fasen\u00e9 platne<\/strong><\/li>\n\n\n\n<li><strong>Kon\u0161tantn\u00e1 miera za\u0165a\u017eenia alebo pohybu platne<\/strong><\/li>\n\n\n\n<li><strong>Presn\u00e9 meranie sily v newtnoch<\/strong><\/li>\n\n\n\n<li><strong>Mo\u017enos\u0165 zaznamen\u00e1vania \u00fadajov a kalibr\u00e1cie v re\u00e1lnom \u010dase<\/strong><\/li>\n<\/ul>\n\n\n\n<p><strong data-start=\"4752\" data-end=\"4780\">Cell Instruments\u2019 MPT-02<\/strong> je na tak\u00e9to aplik\u00e1cie \u0161peci\u00e1lne vytvoren\u00fd. V\u010faka digit\u00e1lnym sn\u00edma\u010dom za\u0165a\u017eenia, programovate\u013en\u00fdm testovac\u00edm parametrom a zhode s medzin\u00e1rodn\u00fdmi normami je ide\u00e1lny na v\u00fdskum a v\u00fdvoj a rutinn\u00e9 <strong data-start=\"4952\" data-end=\"4971\">sila tablety<\/strong> overenie.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">D\u00f4vern\u00e9 vedenie testovania <\/h2>\n\n\n\n<p>Pochopenie a uplat\u0148ovanie <a href=\"https:\/\/www.uspnf.com\/notices\/general-chapter-prospectus-tablet-breaking-force-1217\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">USP<\/a> \u00a0zabezpe\u010duje, aby tablety sp\u013a\u0148ali celosvetov\u00e9 normy mechanickej pevnosti. \u010ci u\u017e vykon\u00e1vate <strong data-start=\"5181\" data-end=\"5205\">test tvrdosti tabliet<\/strong>, <strong data-start=\"5207\" data-end=\"5227\">kompresn\u00fd test<\/strong>, <strong data-start=\"5229\" data-end=\"5248\">sk\u00fa\u0161ka drobivosti<\/strong>, alebo vyhodnocovanie <strong data-start=\"5264\" data-end=\"5286\">krehkos\u0165 tabliet<\/strong>, dodr\u017eiavanie tohto r\u00e1mca zlep\u0161uje kvalitu v\u00fdrobkov, zni\u017euje po\u010det por\u00fach a podporuje dodr\u017eiavanie pr\u00e1vnych predpisov.<\/p>\n\n\n\n<p><strong data-start=\"5394\" data-end=\"5424\">Cell Instruments <\/strong>podporuje profesion\u00e1lov vo farmaceutickom, potravin\u00e1rskom a obalovom priemysle \u0161pi\u010dkov\u00fdmi rie\u0161eniami, ako je<a href=\"https:\/\/www.packqc.com\/sk\/tablet-hardness-tester\/\" target=\"_blank\" rel=\"noopener\"> <strong data-start=\"5535\" data-end=\"5568\">MPT-02 Tester tvrdosti tabliet<\/strong><\/a>, \u010do umo\u017e\u0148uje presn\u00e9, reprodukovate\u013en\u00e9 a \u0161tandardn\u00e9 testovanie vo v\u0161etk\u00fdch oblastiach.<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Z\u00e1kladn\u00e9 sk\u00fa\u0161ky zahrnut\u00e9 v norme USP 1217 Sk\u00fa\u0161ka tvrdosti tabliet a sila l\u00e1mania Sk\u00fa\u0161ka tvrdosti tabliet v norme USP sa \u010dasto nespr\u00e1vne ch\u00e1pe ako povrchov\u00e1 tvrdos\u0165, ale v skuto\u010dnosti sa vz\u0165ahuje na silu l\u00e1mania - tlak potrebn\u00fd na to, aby sa tableta zlomila. Ide o k\u013e\u00fa\u010dov\u00fd ukazovate\u013e pevnosti v \u0165ahu a celistvosti pri lisovan\u00ed. Test sa zvy\u010dajne vykon\u00e1va pomocou [...]<\/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\/sk\/wp-json\/wp\/v2\/standard\/9852","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/media\/7251"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/media?parent=9852"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/standard-category?post=9852"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}