{"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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">\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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\">\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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>Teste esen\u021biale acoperite de USP 1217 Testul de duritate a comprimatelor \u0219i for\u021ba de rupere Adesea \u00een\u021beles gre\u0219it ca duritate de suprafa\u021b\u0103, testul de duritate a comprimatelor din standardul USP se refer\u0103 de fapt la for\u021ba de rupere - presiunea necesar\u0103 pentru a provoca fracturarea comprimatului. Acesta este un indicator cheie al rezisten\u021bei la trac\u021biune \u0219i al integrit\u0103\u021bii la compresie. Testul este efectuat de obicei folosind [...]<\/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}]}}