{"id":35907,"date":"2022-07-22T11:40:15","date_gmt":"2022-07-22T04:40:15","guid":{"rendered":"https:\/\/techmaster.com.vn\/?page_id=35907"},"modified":"2022-07-22T11:51:26","modified_gmt":"2022-07-22T04:51:26","slug":"usp-1788-review","status":"publish","type":"page","link":"https:\/\/techmaster.com.vn\/en\/usp-1788-review\/","title":{"rendered":"USP 1788 Review"},"content":{"rendered":" \t<section class=\"section\" id=\"section_1610344243\">\n\t\t<div class=\"bg section-bg fill bg-fill  \" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t <div class=\"row\"  id=\"row-1522101172\"> \n\t<div id=\"col-1738544750\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t \t<div id=\"text-2850203271\" class=\"text\">\n\t\t\r\n<h1>Application Note<\/h1>\r\n\t\t\n<style>\n#text-2850203271 {\n  font-size: 1.6rem;\n  line-height: 1.2;\n  color: rgb(255,255,255);\n}\n#text-2850203271 > * {\n  color: rgb(255,255,255);\n}\n<\/style>\n\t<\/div>\n\t \t\t<\/div>\n\t\t\t\t\n<style>\n#col-1738544750 > .col-inner {\n  padding: 0px 0px 0px 40px;\n  margin: 0px 0px -55px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t <\/div> \t\t<\/div>\n\n\t\t\n<style>\n#section_1610344243 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n}\n#section_1610344243 .section-bg.bg-loaded {\n  background-image: url(https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/07\/banner-knowledge.jpeg);\n}\n#section_1610344243 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_1610344243 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n\t<\/section>\n\t \t<section class=\"section\" id=\"section_670315721\">\n\t\t<div class=\"bg section-bg fill bg-fill  bg-loaded\" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t <div class=\"row\"  id=\"row-406999586\"> \n\t<div id=\"col-2069658762\" class=\"col medium-8 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\r\n<h2><span data-text-color=\"alert\">USP 1788 Methods Review<\/span><\/h2>\r\n<p>In May 2021 a revision to\u00a0<em>USP 1788 Methods for Determination of Subvisible Particulate Matter<\/em>\u00a0was published, its aim is to aid in clarification and support of the information given in chapters\u00a0<em><span data-text-color=\"alert\">USP 788<\/span>\u00a0Particulate Matter in Injections<\/em>,\u00a0<em>USP 789 Particulate Matter in Ophthalmic Solutions<\/em>, and\u00a0<em>USP 787 Sub-visible Particulate Matter in Therapeutic Protein Injections<\/em>. It was previously titled,\u00a0<em>Methods for the Determination of Particulate Matter in Injections and Ophthalmic Solutions<\/em>, and was focused on the validation and instrument requirements of Light Obscuration instruments and microscopic methods variability. However, with the advent of Flow Imaging technologies and new therapeutic protein solutions, the scope was widened. The document\u2019s changes are a valuable orthogonal method that provides complimentary morphology information. Enhanced knowledge of particle type aids in the determination of contamination source and potential correction, if found to be of adverse levels.<\/p>\r\n<p><span data-text-color=\"alert\">Particle Measuring Systems\u2019(PMS)<\/span>\u00a0<span data-text-color=\"alert\"><strong>APSS-2000 testing system<\/strong><\/span>\u00a0fully complies with the requirements for use in the testing of solutions in the Normative Chapters:<\/p>\r\n<ul>\r\n<li>&lt;788&gt; Particulate Matter in Injections,<\/li>\r\n<li>&lt;789&gt; Particulate Matter in Ophthalmic Solutions and<\/li>\r\n<li>&lt;787&gt; Sub-visible Particulate Matter in Therapeutic Protein Injections<\/li>\r\n<\/ul>\r\n<p>And complies with the requirements in the General Chapters:<\/p>\r\n<ul>\r\n<li>USP 1788 Methods for Determination of Subvisible Particulate Matter<\/li>\r\n<li>USP 1788.1 Light Obscuration Method for the Determination of Subvisible Particulate Matter<\/li>\r\n<\/ul>\r\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2069658762 > .col-inner {\n  padding: 0px 0px 0px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t \n\t<div id=\"col-726689795\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t \t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_1663672173\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"139\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/07\/USP-and-particle-size-1-400x139-1.png\" class=\"attachment-large size-large\" alt=\"USP 1788 Methods Review\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_1663672173 {\n  width: 100%;\n}\n<\/style>\n\t<\/div>\n\t \t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t <\/div> \t\t<\/div>\n\n\t\t\n<style>\n#section_670315721 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  background-color: rgb(255,255,255);\n}\n#section_670315721 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_670315721 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n\t<\/section>\n\t ","protected":false},"excerpt":{"rendered":"","protected":false},"author":176,"featured_media":35916,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-blank.php","meta":{"footnotes":""},"class_list":["post-35907","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - 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