{"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\/hu\/standard\/usp-1217\/","title":{"rendered":"USP"},"content":{"rendered":"<h2 class=\"wp-block-heading\">Az USP 1217 \u00e1ltal lefedett alapvet\u0151 vizsg\u00e1latok<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Tabletta kem\u00e9nys\u00e9gvizsg\u00e1lat \u00e9s t\u00f6r\u0151er\u0151<\/h3>\n\n\n\n<p>Gyakran f\u00e9lre\u00e9rtik a fel\u00fcleti kem\u00e9nys\u00e9get, a <strong data-start=\"2103\" data-end=\"2127\">tabletta kem\u00e9nys\u00e9gvizsg\u00e1lat<\/strong> az USP szabv\u00e1nyban val\u00f3j\u00e1ban a <strong data-start=\"2165\" data-end=\"2183\">t\u00f6r\u0151er\u0151<\/strong>-a tabletta t\u00f6r\u00e9s\u00e9hez sz\u00fcks\u00e9ges nyom\u00e1s. Ez a szak\u00edt\u00f3szil\u00e1rds\u00e1g \u00e9s a t\u00f6m\u00f6r\u00edt\u00e9si integrit\u00e1s kulcsfontoss\u00e1g\u00fa mutat\u00f3ja. A vizsg\u00e1latot jellemz\u0151en olyan automatiz\u00e1lt tesztel\u0151kkel v\u00e9gzik, mint a <a href=\"https:\/\/www.celtec.cn\/newsinfo\/7623506.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"2373\" data-end=\"2406\">MPT-02 tabletta kem\u00e9nys\u00e9gm\u00e9r\u0151<\/strong><\/a> az Cell Instruments-t\u0151l, amely egyenletes terhel\u00e9si sebess\u00e9get \u00e9s pontos er\u0151alkalmaz\u00e1st biztos\u00edt.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Kompresszi\u00f3s teszt<\/h3>\n\n\n\n<p>A <strong data-start=\"2530\" data-end=\"2550\">t\u00f6m\u00f6r\u00edt\u00e9si pr\u00f3ba<\/strong> a tablett\u00e1k, k\u00fcl\u00f6n\u00f6sen a kerek tablett\u00e1k \u00e1tm\u00e9r\u0151je szerinti bet\u00f6lt\u00e9se. Az er\u0151t k\u00e9t lemez k\u00f6z\u00f6tt kell alkalmazni, am\u00edg a tabletta el nem t\u00f6rik. K\u00fcl\u00f6nleges form\u00e1j\u00fa vagy bemetszett tablett\u00e1k eset\u00e9ben alternat\u00edv m\u00f3dszerek, p\u00e9ld\u00e1ul <strong data-start=\"2750\" data-end=\"2779\">h\u00e1rompontos hajl\u00edt\u00f3vizsg\u00e1latok<\/strong> aj\u00e1nlott. A <strong data-start=\"2801\" data-end=\"2820\">terhel\u00e9si sebess\u00e9g<\/strong>, a lemezp\u00e1rhuzamoss\u00e1g \u00e9s a kalibr\u00e1ci\u00f3s pontoss\u00e1g k\u00f6zvetlen\u00fcl befoly\u00e1solja a vizsg\u00e1lat megb\u00edzhat\u00f3s\u00e1g\u00e1t.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Ropoghat\u00f3s\u00e1gi vizsg\u00e1lat (USP szerint)<\/h3>\n\n\n\n<p>M\u00edg az USP  a t\u00f6r\u0151er\u0151re helyezi a hangs\u00falyt, addig a morzsal\u00e9koss\u00e1gi vizsg\u00e1latot az USP  szab\u00e1lyozza. Ez a vizsg\u00e1lat a tabletta forg\u00f3dobban val\u00f3 forgat\u00e1s\u00e1t szimul\u00e1lja, hogy meghat\u00e1rozz\u00e1k a k\u00f6vetkez\u0151 \u00e9rt\u00e9keket <strong data-start=\"3107\" data-end=\"3129\">&nbsp;t\u00f6r\u00e9kenys\u00e9g<\/strong> \u00e9s <strong data-start=\"3134\" data-end=\"3157\">kop\u00e1s\u00e1ll\u00f3s\u00e1g<\/strong>. A s\u00falyvesztes\u00e9g a bukfencez\u00e9s ut\u00e1n sz\u00e1mszer\u0171s\u00edti a t\u00f6r\u00e9kenys\u00e9get. Az elfogadhat\u00f3 s\u00falyvesztes\u00e9g \u00e1ltal\u00e1ban \u22641%. Ez a vizsg\u00e1lat kieg\u00e9sz\u00edti a kem\u00e9nys\u00e9gvizsg\u00e1latot, mivel megmutatja, hogy a tablett\u00e1k hogyan b\u00edrj\u00e1k a dinamikus mechanikai ig\u00e9nybev\u00e9telt.<\/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=\"Tabletta kem\u00e9nys\u00e9g\u00e9nek vizsg\u00e1lata Gy\u00f3gyszertablett\u00e1k nyom\u00f3 kem\u00e9nys\u00e9g\u00e9nek vizsg\u00e1lata\" 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\">Az USP 1217 \u00e9s fontoss\u00e1g\u00e1nak meg\u00e9rt\u00e9se<\/h2>\n\n\n\n<p>Az USP  ismerteti a k\u00f6vetkez\u0151k \u00e9rt\u00e9kel\u00e9s\u00e9re szolg\u00e1l\u00f3 elj\u00e1r\u00e1sokat <strong data-start=\"1294\" data-end=\"1313\">tabletta er\u0151ss\u00e9ge<\/strong>, a mechanikai tulajdons\u00e1gokra \u00f6sszpontos\u00edtva, mint p\u00e9ld\u00e1ul <strong data-start=\"1357\" data-end=\"1375\">t\u00f6r\u0151er\u0151<\/strong>, <strong data-start=\"1377\" data-end=\"1398\">nyom\u00f3szil\u00e1rds\u00e1g<\/strong>, \u00e9s <strong data-start=\"1404\" data-end=\"1424\">szak\u00edt\u00f3szil\u00e1rds\u00e1g<\/strong>. Ezek a param\u00e9terek d\u00f6nt\u0151 fontoss\u00e1g\u00faak annak biztos\u00edt\u00e1s\u00e1hoz, hogy a tablett\u00e1k meg\u0151rizz\u00e9k szerkezeti integrit\u00e1sukat, am\u00edg eljutnak a fogyaszt\u00f3hoz. A szabv\u00e1ny t\u00e1mogatja a k\u00f6vetkezetes vizsg\u00e1lati gyakorlatokat az ipar\u00e1gakban, a gy\u00f3gyszerekt\u0151l a t\u00e1pl\u00e1l\u00e9kkieg\u00e9sz\u00edt\u0151kig.<\/p>\n\n\n\n<p>Az ebben a szabv\u00e1nyban meghat\u00e1rozott szak\u00edt\u00f3er\u0151-vizsg\u00e1lat olyan prec\u00edzi\u00f3s mechanikus vagy motoros vizsg\u00e1l\u00f3berendez\u00e9seket haszn\u00e1l, amelyek t\u00f6r\u00e9sig nyom\u00f3terhel\u00e9st alkalmaznak a tablett\u00e1kra. Ezek a m\u00e9r\u00e9sek a term\u00e9kfejleszt\u00e9st ir\u00e1ny\u00edtj\u00e1k \u00e9s biztos\u00edtj\u00e1k <strong data-start=\"1874\" data-end=\"1893\">min\u0151s\u00e9gellen\u0151rz\u00e9s<\/strong> a formul\u00e1z\u00e1s vagy a gy\u00e1rt\u00e1s lehets\u00e9ges gyenge pontjainak azonos\u00edt\u00e1s\u00e1val.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">H\u00e1rompontos hajl\u00edt\u00f3vizsg\u00e1lat speci\u00e1lis tablettaform\u00e1khoz<\/h2>\n\n\n\n<p>A lapos vagy kapszula alak\u00fa tablett\u00e1k nem t\u00f6rnek \u00f6ssze k\u00f6vetkezetesen a t\u00f6m\u00f6r\u00edt\u00e9s hat\u00e1s\u00e1ra. Ilyen esetekben a <strong data-start=\"3518\" data-end=\"3546\">h\u00e1rompontos hajl\u00edt\u00f3vizsg\u00e1lat<\/strong> jobb \u00e9rt\u00e9kel\u00e9st ny\u00fajt a k\u00f6vetkez\u0151kr\u0151l <strong data-start=\"3579\" data-end=\"3604\">tabletta t\u00f6r\u0151ereje<\/strong> \u00e9s a bels\u0151 szerkezet rugalmass\u00e1ga. Ez a berendez\u00e9s a tablett\u00e1kat mindk\u00e9t v\u00e9g\u00e9n megt\u00e1masztja, \u00e9s a k\u00f6zep\u00e9n t\u00f6r\u0151er\u0151t alkalmaz, \u00edgy pontos szak\u00edt\u00f3szil\u00e1rds\u00e1gi adatokat szolg\u00e1ltat, amelyek k\u00fcl\u00f6n\u00f6sen hasznosak a k\u00f6vetkez\u0151 esetekben <strong data-start=\"3790\" data-end=\"3817\">tabletta t\u00f6r\u00e9kenys\u00e9g\u00e9nek vizsg\u00e1lata<\/strong> \u00e9rt\u00e9kel\u00e9sek.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Tabletta t\u00f6r\u00e9kenys\u00e9g \u00e9s szak\u00edt\u00f3szil\u00e1rds\u00e1g elemz\u00e9se<\/h2>\n\n\n\n<p>A t\u00f6r\u00e9keny tablett\u00e1k hajlamosabbak a kezel\u00e9s sor\u00e1n t\u00f6rt\u00e9n\u0151 lepattan\u00e1sra, reped\u00e9sre vagy t\u00f6r\u00e9sre. Az USP-szabv\u00e1ny \u00f6szt\u00f6nzi a k\u00f6vetkez\u0151k kisz\u00e1m\u00edt\u00e1s\u00e1t <strong data-start=\"4009\" data-end=\"4029\">szak\u00edt\u00f3szil\u00e1rds\u00e1g<\/strong> a t\u00f6r\u0151er\u0151, a tabletta \u00e1tm\u00e9r\u0151je \u00e9s vastags\u00e1ga alapj\u00e1n. Ez az elemz\u00e9s k\u00fcl\u00f6n\u00f6sen hasznos a k\u00fcl\u00f6nb\u00f6z\u0151 formul\u00e1ci\u00f3k \u00f6sszehasonl\u00edt\u00e1s\u00e1hoz \u00e9s az adagol\u00e1s egys\u00e9gess\u00e9g\u00e9nek biztos\u00edt\u00e1s\u00e1hoz.<\/p>\n\n\n\n<p>A modern tesztel\u0151k, mint p\u00e9ld\u00e1ul a <strong data-start=\"4225\" data-end=\"4258\">MPT-02 tabletta kem\u00e9nys\u00e9gm\u00e9r\u0151<\/strong>, programozhat\u00f3 terhel\u00e9si sebess\u00e9get, k\u00f6vetkezetes elmozdul\u00e1s-szab\u00e1lyoz\u00e1st \u00e9s nagy felbont\u00e1s\u00fa digit\u00e1lis kijelz\u0151ket k\u00edn\u00e1lnak, amelyek t\u00e1mogatj\u00e1k a pontos szak\u00edt\u00f3- \u00e9s t\u00f6m\u00f6r\u00edt\u00e9si adatok gy\u0171jt\u00e9s\u00e9t.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">A megfelel\u0151 tabletta kem\u00e9nys\u00e9gm\u00e9r\u0151 kiv\u00e1laszt\u00e1sa<\/h2>\n\n\n\n<p>Az USP  teljes\u00edtm\u00e9nyk\u00f6vetelm\u00e9nyeinek teljes\u00edt\u00e9s\u00e9hez a tesztel\u0151knek biztos\u00edtaniuk kell:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>P\u00e1rhuzamos, prec\u00edzi\u00f3san csiszolt lemezek<\/strong><\/li>\n\n\n\n<li><strong>\u00c1lland\u00f3 terhel\u00e9si sebess\u00e9g vagy lemezmozg\u00e1s<\/strong><\/li>\n\n\n\n<li><strong>Pontos er\u0151m\u00e9r\u00e9s newtonban<\/strong><\/li>\n\n\n\n<li><strong>Val\u00f3s idej\u0171 adatnapl\u00f3z\u00e1s \u00e9s kalibr\u00e1ci\u00f3s k\u00e9pess\u00e9g<\/strong><\/li>\n<\/ul>\n\n\n\n<p><strong data-start=\"4752\" data-end=\"4780\">Cell Instruments\u2019 MPT-02<\/strong> kifejezetten ilyen alkalmaz\u00e1sokhoz k\u00e9sz\u00fclt. A digit\u00e1lis terhel\u00e9scell\u00e1kkal, a programozhat\u00f3 vizsg\u00e1lati param\u00e9terekkel \u00e9s a nemzetk\u00f6zi szabv\u00e1nyoknak val\u00f3 megfelel\u00e9ssel ide\u00e1lis a K+F \u00e9s a rutinszer\u0171 vizsg\u00e1latokhoz. <strong data-start=\"4952\" data-end=\"4971\">tabletta er\u0151ss\u00e9ge<\/strong> ellen\u0151rz\u00e9s.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">A tesztel\u00e9s magabiztos ir\u00e1ny\u00edt\u00e1sa <\/h2>\n\n\n\n<p>A k\u00f6vetkez\u0151k meg\u00e9rt\u00e9se \u00e9s alkalmaz\u00e1sa <a href=\"https:\/\/www.uspnf.com\/notices\/general-chapter-prospectus-tablet-breaking-force-1217\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">USP<\/a> \u00a0biztos\u00edtja, hogy a tablett\u00e1k megfeleljenek a mechanikai szil\u00e1rds\u00e1gra vonatkoz\u00f3 glob\u00e1lis szabv\u00e1nyoknak. Ak\u00e1r egy <strong data-start=\"5181\" data-end=\"5205\">tabletta kem\u00e9nys\u00e9gvizsg\u00e1lat<\/strong>, <strong data-start=\"5207\" data-end=\"5227\">t\u00f6m\u00f6r\u00edt\u00e9si pr\u00f3ba<\/strong>, <strong data-start=\"5229\" data-end=\"5248\">morzsal\u00e9koss\u00e1gi vizsg\u00e1lat<\/strong>, vagy ki\u00e9rt\u00e9keli <strong data-start=\"5264\" data-end=\"5286\">tabletta t\u00f6r\u00e9kenys\u00e9ge<\/strong>, e keretrendszer k\u00f6vet\u00e9se jav\u00edtja a term\u00e9kmin\u0151s\u00e9get, cs\u00f6kkenti a hib\u00e1k sz\u00e1m\u00e1t, \u00e9s t\u00e1mogatja a jogszab\u00e1lyoknak val\u00f3 megfelel\u00e9st.<\/p>\n\n\n\n<p><strong data-start=\"5394\" data-end=\"5424\">Cell Instruments <\/strong>a gy\u00f3gyszer-, \u00e9lelmiszer- \u00e9s csomagol\u00f3iparban dolgoz\u00f3 szakembereket t\u00e1mogatja olyan \u00e9lvonalbeli megold\u00e1sokkal, mint a<a href=\"https:\/\/www.packqc.com\/hu\/tablet-hardness-tester\/\" target=\"_blank\" rel=\"noopener\"> <strong data-start=\"5535\" data-end=\"5568\">MPT-02 tabletta kem\u00e9nys\u00e9gm\u00e9r\u0151<\/strong><\/a>, lehet\u0151v\u00e9 t\u00e9ve a pontos, reproduk\u00e1lhat\u00f3 \u00e9s a szabv\u00e1nyoknak megfelel\u0151 tesztel\u00e9st minden\u00fctt.<\/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\/hu\/wp-json\/wp\/v2\/standard\/9852","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/hu\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/hu\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/hu\/wp-json\/wp\/v2\/media\/7251"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/hu\/wp-json\/wp\/v2\/media?parent=9852"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/hu\/wp-json\/wp\/v2\/standard-category?post=9852"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}