{"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\/ro\/standard\/usp-1217\/","title":{"rendered":"USP"},"content":{"rendered":"<h2 class=\"wp-block-heading\">Teste esen\u021biale acoperite de USP 1217<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Test de duritate a comprimatelor \u0219i for\u021b\u0103 de rupere<\/h3>\n\n\n\n<p>Adesea \u00een\u021beleas\u0103 gre\u0219it ca duritate a suprafe\u021bei, <strong data-start=\"2103\" data-end=\"2127\">testul de duritate a comprimatelor<\/strong> \u00een standardul USP se refer\u0103 de fapt la <strong data-start=\"2165\" data-end=\"2183\">for\u021ba de rupere<\/strong>-presiunea necesar\u0103 pentru a provoca fracturarea tabletei. Acesta este un indicator cheie al rezisten\u021bei la trac\u021biune \u0219i al integrit\u0103\u021bii compresiei. Testul este efectuat de obicei cu ajutorul unor testere automate, cum ar fi <a href=\"https:\/\/www.celtec.cn\/newsinfo\/7623506.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"2373\" data-end=\"2406\">MPT-02 Tester de duritate a tabletelor<\/strong><\/a> de la Cell Instruments, care asigur\u0103 rate de \u00eenc\u0103rcare constante \u0219i aplicarea precis\u0103 a for\u021bei.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Test de compresie<\/h3>\n\n\n\n<p>The <strong data-start=\"2530\" data-end=\"2550\">test de compresie<\/strong> presupune \u00eenc\u0103rcarea diametral\u0103 a comprimatelor, \u00een special a celor rotunde. For\u021ba este aplicat\u0103 \u00eentre dou\u0103 platane p\u00e2n\u0103 c\u00e2nd comprimatul se rupe. Pentru forme speciale sau tablete crestate, se folosesc metode alternative, cum ar fi <strong data-start=\"2750\" data-end=\"2779\">\u00eencerc\u0103ri de \u00eencovoiere \u00een trei puncte<\/strong> sunt recomandate. Se recomand\u0103 <strong data-start=\"2801\" data-end=\"2820\">rata de \u00eenc\u0103rcare<\/strong>, paralelismul pl\u0103cii \u0219i precizia calibr\u0103rii afecteaz\u0103 \u00een mod direct fiabilitatea testului.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Test de friabilitate (conform USP )<\/h3>\n\n\n\n<p>\u00cen timp ce USP  pune accentul pe for\u021ba de rupere, testarea friabilit\u0103\u021bii este reglementat\u0103 de USP  . Acest test simuleaz\u0103 rostogolirea comprimatelor \u00eentr-un tambur rotativ pentru a determina <strong data-start=\"3107\" data-end=\"3129\">&nbsp;fragilitate<\/strong> \u015fi <strong data-start=\"3134\" data-end=\"3157\">rezisten\u021b\u0103 la abraziune<\/strong>. Pierderea \u00een greutate dup\u0103 rotire cuantific\u0103 friabilitatea. O pierdere \u00een greutate acceptabil\u0103 este de obicei \u22641%. Acest test completeaz\u0103 testul de duritate, dezv\u0103luind modul \u00een care tabletele rezist\u0103 la solicit\u0103ri mecanice dinamice.<\/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=\"Testarea durit\u0103\u021bii tabletelor Test de duritate compresiv\u0103 pentru tablete de medicamente\" 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\">\u00cen\u021belegerea USP 1217 \u0219i a importan\u021bei sale<\/h2>\n\n\n\n<p>USP  prezint\u0103 procedurile de evaluare <strong data-start=\"1294\" data-end=\"1313\">puterea tabletei<\/strong>, concentr\u00e2ndu-se asupra propriet\u0103\u021bilor mecanice, cum ar fi <strong data-start=\"1357\" data-end=\"1375\">for\u021ba de rupere<\/strong>, <strong data-start=\"1377\" data-end=\"1398\">rezisten\u021b\u0103 la strivire<\/strong>, \u0219i <strong data-start=\"1404\" data-end=\"1424\">rezisten\u021b\u0103 la trac\u021biune<\/strong>. Ace\u0219ti parametri sunt esen\u021biali pentru a se asigura c\u0103 tabletele \u00ee\u0219i men\u021bin integritatea structural\u0103 p\u00e2n\u0103 c\u00e2nd ajung la consumator. Standardul sus\u021bine practici de testare coerente \u00een toate industriile, de la produse farmaceutice la suplimente nutritive.<\/p>\n\n\n\n<p>Testarea for\u021bei de rupere, astfel cum este definit\u0103 \u00een prezentul standard, utilizeaz\u0103 testere mecanice sau motorizate de precizie care aplic\u0103 o sarcin\u0103 de compresie tabletelor p\u00e2n\u0103 la producerea fracturii. Aceste m\u0103sur\u0103tori orienteaz\u0103 dezvoltarea produsului \u0219i asigur\u0103 <strong data-start=\"1874\" data-end=\"1893\">controlul calitatii<\/strong> prin identificarea poten\u021bialelor puncte slabe \u00een formulare sau fabrica\u021bie.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Test de \u00eendoire \u00een trei puncte pentru forme speciale de tablete<\/h2>\n\n\n\n<p>Este posibil ca comprimatele plate sau sub form\u0103 de capsule s\u0103 nu se rup\u0103 \u00een mod constant la compresie. \u00cen astfel de cazuri, <strong data-start=\"3518\" data-end=\"3546\">\u00eencercare de \u00eencovoiere \u00een trei puncte<\/strong> ofer\u0103 o mai bun\u0103 evaluare a <strong data-start=\"3579\" data-end=\"3604\">For\u021ba de rupere a tabletei<\/strong> \u0219i rezilien\u021ba structurii interne. Aceast\u0103 configura\u021bie sprijin\u0103 tabletele la ambele capete \u0219i aplic\u0103 o for\u021b\u0103 de rupere la jum\u0103tatea lor, furniz\u00e2nd date precise privind rezisten\u021ba la trac\u021biune, utile \u00een special \u00een <strong data-start=\"3790\" data-end=\"3817\">testul de fragilitate a tabletelor<\/strong> evalu\u0103ri.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Analiza fragilit\u0103\u021bii comprimatelor \u0219i a rezisten\u021bei la trac\u021biune<\/h2>\n\n\n\n<p>Tabletele fragile sunt mai predispuse la ciobire, cr\u0103pare sau rupere \u00een timpul manipul\u0103rii. Standardul USP \u00eencurajeaz\u0103 calcularea <strong data-start=\"4009\" data-end=\"4029\">rezisten\u021b\u0103 la trac\u021biune<\/strong> pe baza for\u021bei de rupere, a diametrului \u0219i a grosimii comprimatelor. Aceast\u0103 analiz\u0103 este deosebit de util\u0103 pentru evaluarea comparativ\u0103 a diferitelor formul\u0103ri \u0219i pentru asigurarea uniformit\u0103\u021bii dozelor.<\/p>\n\n\n\n<p>Testere moderne, cum ar fi <strong data-start=\"4225\" data-end=\"4258\">MPT-02 Tester de duritate a tabletelor<\/strong>, ofer\u0103 viteze de \u00eenc\u0103rcare programabile, un control consistent al deplas\u0103rii \u0219i citiri digitale de \u00eenalt\u0103 rezolu\u021bie, sprijinind colectarea precis\u0103 a datelor de trac\u021biune \u0219i compresie.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Alegerea testerului potrivit de duritate a comprimatelor<\/h2>\n\n\n\n<p>Pentru a \u00eendeplini cerin\u021bele de performan\u021b\u0103 ale USP  , testerele trebuie s\u0103 furnizeze:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Platane paralele, rectificate cu precizie<\/strong><\/li>\n\n\n\n<li><strong>Rata de \u00eenc\u0103rcare constant\u0103 sau mi\u0219carea pl\u0103cii<\/strong><\/li>\n\n\n\n<li><strong>M\u0103surarea precis\u0103 a for\u021bei \u00een newtoni<\/strong><\/li>\n\n\n\n<li><strong>\u00cenregistrare \u00een timp real a datelor \u0219i capacitate de calibrare<\/strong><\/li>\n<\/ul>\n\n\n\n<p><strong data-start=\"4752\" data-end=\"4780\">Cell Instruments' MPT-02<\/strong> este construit special pentru astfel de aplica\u021bii. Cu celule de sarcin\u0103 digitale, parametri de testare programabili \u0219i conformitate cu standardele interna\u021bionale, este ideal pentru cercetare \u0219i dezvoltare \u0219i rutin\u0103 <strong data-start=\"4952\" data-end=\"4971\">puterea tabletei<\/strong> verificare.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u00cendrumarea test\u0103rii cu \u00eencredere <\/h2>\n\n\n\n<p>\u00cen\u021belegerea \u0219i aplicarea <a href=\"https:\/\/www.uspnf.com\/notices\/general-chapter-prospectus-tablet-breaking-force-1217\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">USP<\/a> \u00a0asigur\u0103 c\u0103 tabletele \u00eendeplinesc standardele globale de rezisten\u021b\u0103 mecanic\u0103. Fie c\u0103 efectua\u021bi o <strong data-start=\"5181\" data-end=\"5205\">testul de duritate a comprimatelor<\/strong>, <strong data-start=\"5207\" data-end=\"5227\">test de compresie<\/strong>, <strong data-start=\"5229\" data-end=\"5248\">testul de friabilitate<\/strong>, sau evaluarea <strong data-start=\"5264\" data-end=\"5286\">fragilitatea tabletelor<\/strong>, respectarea acestui cadru \u00eembun\u0103t\u0103\u021be\u0219te calitatea produselor, reduce e\u0219ecurile \u0219i sprijin\u0103 conformitatea cu reglement\u0103rile.<\/p>\n\n\n\n<p><strong data-start=\"5394\" data-end=\"5424\">Instrumente celulare <\/strong>sprijin\u0103 profesioni\u0219tii din industria farmaceutic\u0103, alimentar\u0103 \u0219i de ambalare cu solu\u021bii de ultim\u0103 genera\u021bie precum<a href=\"https:\/\/www.packqc.com\/ro\/tablet-hardness-tester\/\" target=\"_blank\" rel=\"noopener\"> <strong data-start=\"5535\" data-end=\"5568\">MPT-02 Tester de duritate a tabletelor<\/strong><\/a>, permi\u021b\u00e2nd testarea precis\u0103, reproductibil\u0103 \u0219i conform\u0103 cu standardele \u00een general.<\/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\/ro\/wp-json\/wp\/v2\/standard\/9852","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/media\/7251"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/media?parent=9852"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/standard-category?post=9852"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}