{"id":3877,"date":"2024-10-01T17:17:26","date_gmt":"2024-10-01T15:17:26","guid":{"rendered":"https:\/\/amsbiopharma.com\/quality-control-stability\/"},"modified":"2026-09-17T07:17:58","modified_gmt":"2026-09-17T05:17:58","slug":"control-de-calidad-y-estabilidades","status":"publish","type":"page","link":"https:\/\/amsbiopharma.com\/es\/control-de-calidad-y-estabilidades\/","title":{"rendered":"Control de Calidad (QC Testing)\/ GMP"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"3877\" class=\"elementor elementor-3877 elementor-527\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-60677d54 e-flex e-con-boxed e-con e-parent\" data-id=\"60677d54\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-65c8961d e-con-full e-flex e-con e-child\" data-id=\"65c8961d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-5902bb21 e-con-full e-flex e-con e-child\" data-id=\"5902bb21\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4e6694a6 elementor-widget elementor-widget-heading\" data-id=\"4e6694a6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Control de Calidad (QC Testing)\/ GMP<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6f41141d e-con-full e-flex e-con e-child\" data-id=\"6f41141d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-18e2f39a elementor-widget elementor-widget-text-editor\" data-id=\"18e2f39a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Servicios integrales validados de an\u00e1lisis de control de calidad para sustancias activas y productos farmac\u00e9uticos terminados.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-33b0496 e-con-full e-flex e-con e-child\" data-id=\"33b0496\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;video&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-6b89f296 e-con-full e-flex e-con e-child\" data-id=\"6b89f296\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;video&quot;,&quot;background_video_link&quot;:&quot;https:\\\/\\\/amsbiopharma.com\\\/wp-content\\\/uploads\\\/Clip7_QualityControl_Stabilities_SM.mp4&quot;,&quot;background_play_on_mobile&quot;:&quot;yes&quot;,&quot;background_video_start&quot;:0,&quot;background_video_end&quot;:9,&quot;background_play_once&quot;:&quot;yes&quot;}\">\n\t\t<div class=\"elementor-background-video-container\">\n\t\t\t\t\t\t\t<video class=\"elementor-background-video-hosted\" role=\"presentation\" autoplay muted playsinline><\/video>\n\t\t\t\t\t<\/div>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-68da01b e-flex e-con-boxed e-con e-parent\" data-id=\"68da01b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-50c1bad e-con-full e-flex e-con e-child\" data-id=\"50c1bad\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-78bec43 elementor-widget elementor-widget-text-editor\" data-id=\"78bec43\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">El <\/span><b>control de calidad<\/b><span style=\"font-weight: 400;\"> anal\u00edtico es la columna vertebral de la fabricaci\u00f3n farmac\u00e9utica, proporcionando la evidencia documentada requerida para demostrar que cada lote de <\/span><b>sustancia activa<\/b><span style=\"font-weight: 400;\"> y <\/span><b>producto farmac\u00e9utico<\/b><span style=\"font-weight: 400;\"> cumple sus especificaciones de calidad antes de la liberaci\u00f3n. Para un Responsable de Control de Calidad, la fiabilidad, exactitud, conformidad regulatoria y plazo de entrega de los datos anal\u00edticos son primordiales.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma proporciona una cartera integral de servicios de <\/span><b>control de calidad<\/b><span style=\"font-weight: 400;\"> compatibles con <\/span><b>BPF<\/b><span style=\"font-weight: 400;\">, cubriendo la gama completa de ensayos fisicoqu\u00edmicos, qu\u00edmicos y funcionales requeridos para la caracterizaci\u00f3n y liberaci\u00f3n de productos farmac\u00e9uticos. Todo el trabajo se realiza bajo m\u00e9todos validados conformes con normas farmacopeicas y regulatorias.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Nuestros servicios operan bajo un sistema de gesti\u00f3n de calidad alineado con los principios de <\/span><b>BPF<\/b><span style=\"font-weight: 400;\">, con trazabilidad completa, documentaci\u00f3n controlada y procedimientos de integridad de datos conformes con <\/span><b>21 CFR Part 11<\/b><span style=\"font-weight: 400;\"> y <\/span><b>Annex 11<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e3fcaca e-con-full e-flex e-con e-child\" data-id=\"e3fcaca\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fe65606 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"fe65606\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"901\" height=\"365\" src=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/people.png\" class=\"attachment-large size-large wp-image-3649\" alt=\"\" srcset=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/people.png 901w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/people-300x122.png 300w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/people-768x311.png 768w\" sizes=\"(max-width: 901px) 100vw, 901px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-539e908 e-con-full e-flex e-con e-parent\" data-id=\"539e908\" data-element_type=\"container\" data-e-type=\"container\" id=\"discover-menu-container\">\n\t\t<div class=\"elementor-element elementor-element-aa5f7c2 e-con-full title-container e-flex e-con e-child\" data-id=\"aa5f7c2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7fcebe6 elementor-widget elementor-widget-heading\" data-id=\"7fcebe6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Descubre<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1249ddc4 elementor-widget elementor-widget-html\" data-id=\"1249ddc4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8zm144 276c0 6.6-5.4 12-12 12h-92v92c0 6.6-5.4 12-12 12h-56c-6.6 0-12-5.4-12-12v-92h-92c-6.6 0-12-5.4-12-12v-56c0-6.6 5.4-12 12-12h92v-92c0-6.6 5.4-12 12-12h56c6.6 0 12 5.4 12 12v92h92c6.6 0 12 5.4 12 12v56z\"><\/path><\/svg>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-51a5406 elementor-nav-menu--dropdown-none discover-menu elementor-widget elementor-widget-nav-menu\" data-id=\"51a5406\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;layout&quot;:&quot;vertical&quot;,&quot;submenu_icon&quot;:{&quot;value&quot;:&quot;&lt;svg aria-hidden=\\&quot;true\\&quot; class=\\&quot;e-font-icon-svg e-fas-caret-down\\&quot; viewBox=\\&quot;0 0 320 512\\&quot; xmlns=\\&quot;http:\\\/\\\/www.w3.org\\\/2000\\\/svg\\&quot;&gt;&lt;path d=\\&quot;M31.3 192h257.3c17.8 0 26.7 21.5 14.1 34.1L174.1 354.8c-7.8 7.8-20.5 7.8-28.3 0L17.2 226.1C4.6 213.5 13.5 192 31.3 192z\\&quot;&gt;&lt;\\\/path&gt;&lt;\\\/svg&gt;&quot;,&quot;library&quot;:&quot;fa-solid&quot;}}\" data-widget_type=\"nav-menu.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<nav aria-label=\"Men\u00fa\" class=\"elementor-nav-menu--main elementor-nav-menu__container elementor-nav-menu--layout-vertical e--pointer-underline e--animation-fade\">\n\t\t\t\t<ul id=\"menu-1-51a5406\" class=\"elementor-nav-menu sm-vertical\"><li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4099\"><a href=\"https:\/\/amsbiopharma.com\/es\/impurezas-de-medicamentos\/\" class=\"elementor-item\">Impurezas Regulatorias GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4100\"><a href=\"https:\/\/amsbiopharma.com\/es\/soporte-analitico\/\" class=\"elementor-item\">Desarrollo de M\u00e9todos Anal\u00edticos\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4101\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-de-biofarmaceuticos-basados-en-proteinas\/\" class=\"elementor-item\">An\u00e1lisis de P\u00e9ptidos y Amino\u00e1cidos\/ NO GLP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4102\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-de-biofarmaceuticos-basados-en-acidos-nucleicos\/\" class=\"elementor-item\">Oligonucle\u00f3tidos\/ No GLP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4103\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-icp-ms\/\" class=\"elementor-item\">An\u00e1lisis ICP-MS<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4104\"><a href=\"https:\/\/amsbiopharma.com\/es\/control-de-calidad-y-estabilidades\/\" class=\"elementor-item\">Control de Calidad (QC Testing)\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4105\"><a href=\"https:\/\/amsbiopharma.com\/es\/control-microbiologico\/\" class=\"elementor-item\">Microbiolog\u00eda\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4106\"><a href=\"https:\/\/amsbiopharma.com\/es\/cannabis-medicinal\/\" class=\"elementor-item\">Cannabis medicinal<\/a><\/li>\n<\/ul>\t\t\t<\/nav>\n\t\t\t\t\t\t<nav class=\"elementor-nav-menu--dropdown elementor-nav-menu__container\" aria-hidden=\"true\">\n\t\t\t\t<ul id=\"menu-2-51a5406\" class=\"elementor-nav-menu sm-vertical\"><li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4099\"><a href=\"https:\/\/amsbiopharma.com\/es\/impurezas-de-medicamentos\/\" class=\"elementor-item\" tabindex=\"-1\">Impurezas Regulatorias GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4100\"><a href=\"https:\/\/amsbiopharma.com\/es\/soporte-analitico\/\" class=\"elementor-item\" tabindex=\"-1\">Desarrollo de M\u00e9todos Anal\u00edticos\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4101\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-de-biofarmaceuticos-basados-en-proteinas\/\" class=\"elementor-item\" tabindex=\"-1\">An\u00e1lisis de P\u00e9ptidos y Amino\u00e1cidos\/ NO GLP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4102\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-de-biofarmaceuticos-basados-en-acidos-nucleicos\/\" class=\"elementor-item\" tabindex=\"-1\">Oligonucle\u00f3tidos\/ No GLP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4103\"><a href=\"https:\/\/amsbiopharma.com\/es\/analisis-icp-ms\/\" class=\"elementor-item\" tabindex=\"-1\">An\u00e1lisis ICP-MS<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4104\"><a href=\"https:\/\/amsbiopharma.com\/es\/control-de-calidad-y-estabilidades\/\" class=\"elementor-item\" tabindex=\"-1\">Control de Calidad (QC Testing)\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4105\"><a href=\"https:\/\/amsbiopharma.com\/es\/control-microbiologico\/\" class=\"elementor-item\" tabindex=\"-1\">Microbiolog\u00eda\/ GMP<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-4106\"><a href=\"https:\/\/amsbiopharma.com\/es\/cannabis-medicinal\/\" class=\"elementor-item\" tabindex=\"-1\">Cannabis medicinal<\/a><\/li>\n<\/ul>\t\t\t<\/nav>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f89ae9d e-con-full e-flex e-con e-parent\" data-id=\"f89ae9d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-e5abe50 e-con-full e-flex e-con e-child\" data-id=\"e5abe50\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dc45600 elementor-widget elementor-widget-heading\" data-id=\"dc45600\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Nuestro cat\u00e1logo de servicios incluye<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7340c79 e-con-full e-grid e-con e-child\" data-id=\"7340c79\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-94f6eb8 elementor-widget elementor-widget-image\" data-id=\"94f6eb8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"2156\" height=\"1641\" src=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1.webp\" class=\"attachment-full size-full wp-image-6147\" alt=\"Aplicaciones de Metabol\u00f3mica\" srcset=\"https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1.webp 2156w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-300x228.webp 300w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-1024x779.webp 1024w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-768x585.webp 768w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-1536x1169.webp 1536w, https:\/\/amsbiopharma.com\/wp-content\/uploads\/AM_2026_04_01_BLOG-1-2048x1559.webp 2048w\" sizes=\"(max-width: 2156px) 100vw, 2156px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f51c34c elementor-widget elementor-widget-n-accordion\" data-id=\"f51c34c\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;expanded&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2570\" class=\"e-n-accordion-item\" open>\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"true\" aria-controls=\"e-n-accordion-item-2570\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Soporte para Estudios de Estabilidad (HPLC-UV, HPLC-MS\/MS, GC-MS\/MS) <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-down\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 137-111 248-248 248S8 393 8 256 119 8 256 8s248 111 248 248zM212 140v116h-70.9c-10.7 0-16.1 13-8.5 20.5l114.9 114.3c4.7 4.7 12.2 4.7 16.9 0l114.9-114.3c7.6-7.6 2.2-20.5-8.5-20.5H300V140c0-6.6-5.4-12-12-12h-64c-6.6 0-12 5.4-12 12z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2570\" class=\"elementor-element elementor-element-aa246fd e-con-full e-flex e-con e-child\" data-id=\"aa246fd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2570\" class=\"elementor-element elementor-element-1d5f516 e-flex e-con-boxed e-con e-child\" data-id=\"1d5f516\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9890bf6 elementor-widget elementor-widget-text-editor\" data-id=\"9890bf6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Los <\/span><b>estudios de estabilidad<\/b><span style=\"font-weight: 400;\"> proporcionan la base de datos anal\u00edticos para la determinaci\u00f3n de la vida \u00fatil, la definici\u00f3n de las condiciones de almacenamiento y la presentaci\u00f3n regulatoria. Un programa de <\/span><b>estabilidad<\/b><span style=\"font-weight: 400;\"> bien dise\u00f1ado con m\u00e9todos anal\u00edticos indicadores de estabilidad validados es un requisito regulatorio obligatorio conforme al <\/span><b>ICH Q1<\/b><span style=\"font-weight: 400;\"> para todas las <\/span><b>sustancias activas<\/b><span style=\"font-weight: 400;\"> y <\/span><b>productos farmac\u00e9uticos<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma apoya programas de <\/span><b>estabilidad<\/b><span style=\"font-weight: 400;\"> conformes al <\/span><b>ICH Q1<\/b><span style=\"font-weight: 400;\"> con m\u00e9todos indicadores de estabilidad validados que cubren valoraci\u00f3n, <\/span><b>productos de degradaci\u00f3n<\/b><span style=\"font-weight: 400;\">, sustancias relacionadas y otros atributos de calidad relevantes. Nuestro equipo gestiona la recepci\u00f3n de muestras, an\u00e1lisis y gesti\u00f3n de datos. Las plataformas <\/span><b>HPLC-UV<\/b><span style=\"font-weight: 400;\">, <\/span><b>HPLC-MS\/MS<\/b><span style=\"font-weight: 400;\"> y <\/span><b>GC-MS\/MS<\/b><span style=\"font-weight: 400;\"> se aplican seg\u00fan corresponda.<\/span><\/p>\n<p><b>Capacidades anal\u00edticas clave:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Dise\u00f1o, conducci\u00f3n y soporte anal\u00edtico de estudios de <\/span><b>estabilidad<\/b><span style=\"font-weight: 400;\"> conformes al <\/span><b>ICH Q1<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">M\u00e9todos indicadores de <\/span><b>estabilidad<\/b><span style=\"font-weight: 400;\"> validados por <\/span><b>HPLC-UV<\/b><span style=\"font-weight: 400;\">, <\/span><b>HPLC-MS\/MS<\/b><span style=\"font-weight: 400;\"> y <\/span><b>GC-MS\/MS<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Gesti\u00f3n de datos conforme a <\/span><b>21 CFR Part 11<\/b><span style=\"font-weight: 400;\"> y <\/span><b>Annex 11<\/b><\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2571\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2571\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> An\u00e1lisis de Aspecto (Color, Claridad y Part\u00edculas) <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-down\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 137-111 248-248 248S8 393 8 256 119 8 256 8s248 111 248 248zM212 140v116h-70.9c-10.7 0-16.1 13-8.5 20.5l114.9 114.3c4.7 4.7 12.2 4.7 16.9 0l114.9-114.3c7.6-7.6 2.2-20.5-8.5-20.5H300V140c0-6.6-5.4-12-12-12h-64c-6.6 0-12 5.4-12 12z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2571\" class=\"elementor-element elementor-element-88cf768 e-con-full e-flex e-con e-child\" data-id=\"88cf768\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2571\" class=\"elementor-element elementor-element-51edb65 e-flex e-con-boxed e-con e-child\" data-id=\"51edb65\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-049388d elementor-widget elementor-widget-text-editor\" data-id=\"049388d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">El aspecto es un <\/span><b>atributo de calidad<\/b><span style=\"font-weight: 400;\"> fundamental de los productos farmac\u00e9uticos y un ensayo de liberaci\u00f3n obligatorio en todas las formas farmac\u00e9uticas. Las desviaciones en el color, la claridad o las part\u00edculas respecto a las especificaciones definidas pueden indicar degradaci\u00f3n del producto, contaminaci\u00f3n o fallo del proceso de fabricaci\u00f3n.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma realiza ensayos de aspecto validados para color, claridad y materia particulada usando m\u00e9todos visuales e instrumentales calibrados, en conformidad con las especificaciones farmacopeicas y los requisitos regulatorios aplicables.<\/span><\/p>\n<p><b>Capacidades anal\u00edticas clave:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ensayos de aspecto visual e instrumental conforme a <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\"> y <\/span><b>USP<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Evaluaci\u00f3n de color frente a las escalas de referencia farmacopeicas definidas<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Determinaci\u00f3n de claridad para productos en soluci\u00f3n<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">An\u00e1lisis de materia particulada incluyendo part\u00edculas subvisibles<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Aplicable en formas parenterales, l\u00edquidas orales y semis\u00f3lidas<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Documentaci\u00f3n de soporte para <\/span><b>liberaci\u00f3n de lotes<\/b><span style=\"font-weight: 400;\"> y <\/span><b>estabilidad<\/b><\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2572\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2572\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Valoraci\u00f3n y Uniformidad de Dosis (UV\/Vis, HPLC\/UHPLC, GC, GC\/MS, LC\/MS) <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-down\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 137-111 248-248 248S8 393 8 256 119 8 256 8s248 111 248 248zM212 140v116h-70.9c-10.7 0-16.1 13-8.5 20.5l114.9 114.3c4.7 4.7 12.2 4.7 16.9 0l114.9-114.3c7.6-7.6 2.2-20.5-8.5-20.5H300V140c0-6.6-5.4-12-12-12h-64c-6.6 0-12 5.4-12 12z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2572\" class=\"elementor-element elementor-element-427daec e-con-full e-flex e-con e-child\" data-id=\"427daec\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2572\" class=\"elementor-element elementor-element-8e8e065 e-flex e-con-boxed e-con e-child\" data-id=\"8e8e065\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-af4824e elementor-widget elementor-widget-text-editor\" data-id=\"af4824e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">La determinaci\u00f3n de la <\/span><b>valoraci\u00f3n<\/b><span style=\"font-weight: 400;\"> y la <\/span><b>uniformidad de dosis<\/b><span style=\"font-weight: 400;\"> son requisitos fundamentales de <\/span><b>control de calidad<\/b><span style=\"font-weight: 400;\"> para todos los productos farmac\u00e9uticos, proporcionando evidencia cuantitativa de que cada lote contiene la cantidad prevista de <\/span><b>sustancia activa<\/b><span style=\"font-weight: 400;\"> distribuida uniformemente en las unidades de dosificaci\u00f3n.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma aplica m\u00e9todos anal\u00edticos validados en una amplia gama de plataformas: espectrofotometr\u00eda <\/span><b>UV\/Vis<\/b><span style=\"font-weight: 400;\">, <\/span><b>HPLC<\/b><span style=\"font-weight: 400;\"> y <\/span><b>UHPLC<\/b><span style=\"font-weight: 400;\"> con m\u00faltiples modos de detecci\u00f3n, <\/span><b>GC<\/b><span style=\"font-weight: 400;\"> y plataformas <\/span><b>LC-MS<\/b><span style=\"font-weight: 400;\">, seg\u00fan corresponda a cada producto. Todos los m\u00e9todos se validan conforme a la <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\">, la <\/span><b>USP<\/b><span style=\"font-weight: 400;\"> y el <\/span><b>ICH Q2(R2)<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><b>Capacidades anal\u00edticas clave:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">M\u00e9todos de <\/span><b>valoraci\u00f3n<\/b><span style=\"font-weight: 400;\"> validados en <\/span><b>UV\/Vis<\/b><span style=\"font-weight: 400;\">, <\/span><b>HPLC<\/b><span style=\"font-weight: 400;\">\/<\/span><b>UHPLC<\/b><span style=\"font-weight: 400;\">, <\/span><b>GC<\/b><span style=\"font-weight: 400;\">, <\/span><b>GC\/MS<\/b><span style=\"font-weight: 400;\"> y <\/span><b>LC\/MS<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Uniformidad de contenido conforme a <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\"> 2.9.40 y <\/span><b>USP &lt;905&gt;<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Aplicable en formas s\u00f3lidas, l\u00edquidas, semis\u00f3lidas y parenterales<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Validaci\u00f3n de m\u00e9todos conforme a <\/span><b>Ph. Eur.<\/b><span style=\"font-weight: 400;\">, <\/span><b>USP<\/b><span style=\"font-weight: 400;\"> y <\/span><b>ICH Q2(R2)<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Soporte para desarrollo, validaci\u00f3n y <\/span><b>liberaci\u00f3n de lotes<\/b><span style=\"font-weight: 400;\"> rutinaria<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Documentaci\u00f3n completa para presentaciones regulatorias<\/span><\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2573\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2573\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Identificaci\u00f3n y Cuantificaci\u00f3n de Sustancias Relacionadas (HPLC, GC\/MS, LC\/MS)  <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-down\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 137-111 248-248 248S8 393 8 256 119 8 256 8s248 111 248 248zM212 140v116h-70.9c-10.7 0-16.1 13-8.5 20.5l114.9 114.3c4.7 4.7 12.2 4.7 16.9 0l114.9-114.3c7.6-7.6 2.2-20.5-8.5-20.5H300V140c0-6.6-5.4-12-12-12h-64c-6.6 0-12 5.4-12 12z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2573\" class=\"elementor-element elementor-element-b050046 e-con-full e-flex e-con e-child\" data-id=\"b050046\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2573\" class=\"elementor-element elementor-element-7cb4447 e-flex e-con-boxed e-con e-child\" data-id=\"7cb4447\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a210a57 elementor-widget elementor-widget-text-editor\" data-id=\"a210a57\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">El control de <\/span><b>sustancias relacionadas<\/b><span style=\"font-weight: 400;\"> \u2014<\/span><b>impurezas<\/b><span style=\"font-weight: 400;\"> sint\u00e9ticas, <\/span><b>productos de degradaci\u00f3n<\/b><span style=\"font-weight: 400;\"> e <\/span><b>impurezas<\/b><span style=\"font-weight: 400;\"> relacionadas con el proceso\u2014 es una de las actividades de <\/span><b>control de calidad<\/b><span style=\"font-weight: 400;\"> m\u00e1s cr\u00edticas en la fabricaci\u00f3n farmac\u00e9utica. Las autoridades reguladoras exigen que todas las <\/span><b>sustancias activas<\/b><span style=\"font-weight: 400;\"> y <\/span><b>productos farmac\u00e9uticos<\/b><span style=\"font-weight: 400;\"> sean analizados hasta los l\u00edmites definidos, con cualquier <\/span><b>impureza<\/b><span style=\"font-weight: 400;\"> en o por encima de los umbrales de notificaci\u00f3n identificada y calificada.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma proporciona servicios anal\u00edticos validados para la identificaci\u00f3n y cuantificaci\u00f3n de <\/span><b>sustancias relacionadas<\/b><span style=\"font-weight: 400;\"> aplicando <\/span><b>HPLC<\/b><span style=\"font-weight: 400;\">, <\/span><b>GC\/MS<\/b><span style=\"font-weight: 400;\"> y <\/span><b>LC\/MS<\/b><span style=\"font-weight: 400;\"> seg\u00fan las propiedades del f\u00e1rmaco. Los m\u00e9todos se validan conforme al <\/span><b>ICH Q3A<\/b><span style=\"font-weight: 400;\">, <\/span><b>ICH Q3B<\/b><span style=\"font-weight: 400;\"> y <\/span><b>ICH Q2(R2)<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><b>Capacidades anal\u00edticas clave:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">M\u00e9todos <\/span><b>HPLC<\/b><span style=\"font-weight: 400;\">, <\/span><b>GC\/MS<\/b><span style=\"font-weight: 400;\"> y <\/span><b>LC\/MS<\/b><span style=\"font-weight: 400;\"> validados para cuantificaci\u00f3n de <\/span><b>sustancias relacionadas<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Detecci\u00f3n y cuantificaci\u00f3n en o por debajo de los umbrales del <\/span><b>ICH Q3A<\/b><span style=\"font-weight: 400;\">\/<\/span><b>ICH Q3B<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Aplicable en <\/span><b>sustancias activas<\/b><span style=\"font-weight: 400;\">, intermedios y <\/span><b>productos farmac\u00e9uticos<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Perfilado de <\/span><b>impurezas<\/b><span style=\"font-weight: 400;\"> conforme al <\/span><b>ICH Q3A<\/b><span style=\"font-weight: 400;\"> y <\/span><b>ICH Q3B<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Soporte para l\u00edmites de <\/span><b>impurezas<\/b><span style=\"font-weight: 400;\"> y calificaci\u00f3n toxicol\u00f3gica<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">An\u00e1lisis rutinario de <\/span><b>control de calidad<\/b><span style=\"font-weight: 400;\"> con documentaci\u00f3n completa<\/span><\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2574\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2574\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> An\u00e1lisis Fisicoqu\u00edmico (pH, viscosidad, densidad, polarimetr\u00eda, \u00edndice de refracci\u00f3n, osmolalidad) <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-down\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 137-111 248-248 248S8 393 8 256 119 8 256 8s248 111 248 248zM212 140v116h-70.9c-10.7 0-16.1 13-8.5 20.5l114.9 114.3c4.7 4.7 12.2 4.7 16.9 0l114.9-114.3c7.6-7.6 2.2-20.5-8.5-20.5H300V140c0-6.6-5.4-12-12-12h-64c-6.6 0-12 5.4-12 12z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2574\" class=\"elementor-element elementor-element-de20a41 e-con-full e-flex e-con e-child\" data-id=\"de20a41\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2574\" class=\"elementor-element elementor-element-4b533d8 e-flex e-con-boxed e-con e-child\" data-id=\"4b533d8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-526f906 elementor-widget elementor-widget-text-editor\" data-id=\"526f906\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">La caracterizaci\u00f3n f\u00edsica y fisicoqu\u00edmica proporciona datos de <\/span><b>atributos de calidad<\/b><span style=\"font-weight: 400;\"> cr\u00edticos para los productos farmac\u00e9uticos. Para formulaciones l\u00edquidas y semis\u00f3lidas, atributos como el pH, la viscosidad y la osmolalidad son determinantes cr\u00edticos de la <\/span><b>estabilidad<\/b><span style=\"font-weight: 400;\"> del producto y, para los parenterales, de la compatibilidad fisiol\u00f3gica.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma ofrece una gama integral de servicios de an\u00e1lisis f\u00edsico validados que cubren el espectro completo de par\u00e1metros fisicoqu\u00edmicos requeridos para el desarrollo farmac\u00e9utico y el <\/span><b>control de calidad<\/b><span style=\"font-weight: 400;\">, con todos los instrumentos calibrados y cualificados.<\/span><\/p>\n<p><b>Capacidades anal\u00edticas clave:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Medici\u00f3n de pH en toda la gama de tipos de productos farmac\u00e9uticos<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Determinaci\u00f3n de viscosidad mediante instrumentos calibrados<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Densidad y densidad relativa por m\u00e9todos validados<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u00cdndice de refracci\u00f3n para determinaci\u00f3n de identidad y concentraci\u00f3n<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Osmolalidad por descenso criosc\u00f3pico para productos parenterales<\/span><\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2575\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"6\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2575\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><h3 class=\"e-n-accordion-item-title-text\"> Disolventes Residuales e Impurezas Org\u00e1nicas Vol\u00e1tiles (GC-MS)  <\/h3><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-down\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M504 256c0 137-111 248-248 248S8 393 8 256 119 8 256 8s248 111 248 248zM212 140v116h-70.9c-10.7 0-16.1 13-8.5 20.5l114.9 114.3c4.7 4.7 12.2 4.7 16.9 0l114.9-114.3c7.6-7.6 2.2-20.5-8.5-20.5H300V140c0-6.6-5.4-12-12-12h-64c-6.6 0-12 5.4-12 12z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-alt-circle-right\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8c137 0 248 111 248 248S393 504 256 504 8 393 8 256 119 8 256 8zM140 300h116v70.9c0 10.7 13 16.1 20.5 8.5l114.3-114.9c4.7-4.7 4.7-12.2 0-16.9l-114.3-115c-7.6-7.6-20.5-2.2-20.5 8.5V212H140c-6.6 0-12 5.4-12 12v64c0 6.6 5.4 12 12 12z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2575\" class=\"elementor-element elementor-element-1d994f5 e-con-full e-flex e-con e-child\" data-id=\"1d994f5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2575\" class=\"elementor-element elementor-element-467ea1c e-flex e-con-boxed e-con e-child\" data-id=\"467ea1c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7b5fc1b elementor-widget elementor-widget-text-editor\" data-id=\"7b5fc1b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">El control de <\/span><b>disolventes residuales<\/b><span style=\"font-weight: 400;\"> es un requisito obligatorio de <\/span><b>calidad farmac\u00e9utica<\/b><span style=\"font-weight: 400;\"> conforme al <\/span><b>ICH Q3C<\/b><span style=\"font-weight: 400;\">, que clasifica los disolventes por su riesgo toxicol\u00f3gico y define las exposiciones diarias permitidas, los umbrales de notificaci\u00f3n y los l\u00edmites. Las autoridades reguladoras exigen m\u00e9todos anal\u00edticos validados con sensibilidad por debajo de los l\u00edmites establecidos.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">AMSbiopharma proporciona m\u00e9todos de <\/span><b>GC-MS<\/b><span style=\"font-weight: 400;\"> en espacio de cabeza validados para la cuantificaci\u00f3n de <\/span><b>disolventes residuales<\/b><span style=\"font-weight: 400;\"> e <\/span><b>impurezas org\u00e1nicas<\/b><span style=\"font-weight: 400;\"> vol\u00e1tiles de la Clase 1, 2 y 3 del <\/span><b>ICH Q3C<\/b><span style=\"font-weight: 400;\"> en <\/span><b>sustancias activas<\/b><span style=\"font-weight: 400;\">, <\/span><b>productos farmac\u00e9uticos<\/b><span style=\"font-weight: 400;\"> y excipientes. La cromatograf\u00eda de gases con espacio de cabeza y detecci\u00f3n por espectrometr\u00eda de masas proporciona la selectividad y sensibilidad requeridas.<\/span><\/p>\n<p><b>Capacidades anal\u00edticas clave:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">M\u00e9todos de <\/span><b>GC-MS<\/b><span style=\"font-weight: 400;\"> en espacio de cabeza validados para disolventes de Clase 1, 2 y 3 del <\/span><b>ICH Q3C<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Detecci\u00f3n y cuantificaci\u00f3n en o por debajo de los umbrales del <\/span><b>ICH Q3C<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Aplicable en <\/span><b>sustancias activas<\/b><span style=\"font-weight: 400;\">, <\/span><b>productos farmac\u00e9uticos<\/b><span style=\"font-weight: 400;\"> y excipientes<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Validaci\u00f3n de m\u00e9todos conforme al <\/span><b>ICH Q3C<\/b><span style=\"font-weight: 400;\"> y <\/span><b>ICH Q2(R2)<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Soporte para presentaciones regulatorias y <\/span><b>control de calidad<\/b><span style=\"font-weight: 400;\"> rutinario<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Perfilado de <\/span><b>impurezas org\u00e1nicas<\/b><span style=\"font-weight: 400;\"> vol\u00e1tiles m\u00e1s all\u00e1 de los disolventes del <\/span><b>ICH Q3C<\/b><\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<div class=\"entry-summary\">\nControl de Calidad (QC Testing)\/ GMP Servicios integrales validados de an\u00e1lisis de control de calidad para sustancias activas y productos farmac\u00e9uticos terminados. El control de calidad anal\u00edtico es la columna vertebral de la fabricaci\u00f3n farmac\u00e9utica, proporcionando la evidencia documentada requerida&hellip;\n<\/div>\n<div class=\"link-more\"><a href=\"https:\/\/amsbiopharma.com\/es\/control-de-calidad-y-estabilidades\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &ldquo;Control de Calidad (QC Testing)\/ GMP&rdquo;<\/span>&hellip;<\/a><\/div>\n","protected":false},"author":1,"featured_media":4763,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-3877","page","type-page","status-publish","has-post-thumbnail","hentry","entry"],"_links":{"self":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/3877","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/comments?post=3877"}],"version-history":[{"count":23,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/3877\/revisions"}],"predecessor-version":[{"id":6696,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/pages\/3877\/revisions\/6696"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/media\/4763"}],"wp:attachment":[{"href":"https:\/\/amsbiopharma.com\/es\/wp-json\/wp\/v2\/media?parent=3877"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}