{"id":9059,"date":"2021-08-31T20:27:09","date_gmt":"2021-08-31T20:27:09","guid":{"rendered":"http:\/\/insilicall.com\/?p=9059"},"modified":"2023-02-16T19:36:44","modified_gmt":"2023-02-16T19:36:44","slug":"n-nitrosaminas-e-toxicologia-regulatoria-anvisa","status":"publish","type":"post","link":"https:\/\/insilicall.com\/n-nitrosaminas-e-toxicologia-regulatoria-anvisa\/","title":{"rendered":"N-nitrosaminas: toxicologia regulat\u00f3ria e novas diretrizes"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"9059\" class=\"elementor elementor-9059\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-9350899 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9350899\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-2f084\" data-id=\"2f084\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5e4ed6a elementor-widget elementor-widget-text-editor\" data-id=\"5e4ed6a\" data-element_type=\"widget\" data-settings=\"{&quot;ultimate_floating_fx_translate_y&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 05-08-2024 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p style=\"font-family: Roboto, sans-serif;text-align: left\">As<span style=\"font-weight: bold\"> N-nitrosaminas<\/span>\u00a0s\u00e3o um grupo de compostos com elevada toxicidade que est\u00e1 atraindo bastante aten\u00e7\u00e3o nesses \u00faltimos anos.\u00a0<span style=\"letter-spacing: -0.2px\">Falar sobre elas \u00e9 falar sobre seu\u00a0<\/span><span style=\"letter-spacing: -0.2px\">impacto em quest\u00f5es de<span style=\"font-weight: bold\">\u00a0toxicologia regulat\u00f3ria<\/span>\u00a0em IFAs<\/span><span style=\"letter-spacing: -0.2px\">\u00a0(ingredientes farmac\u00eauticos ativos) e outros medicamentos. <br \/>Alguns dos compostos desse grupo apresentam grave risco \u00e0 sa\u00fade humana podendo contribuir <br \/>para a indu\u00e7\u00e3o de c\u00e2ncer e atividades mutag\u00eanicas, quando expostas acima dos n\u00edveis aceit\u00e1veis <br \/>e por longos per\u00edodos de tempo. E em diversas concentra\u00e7\u00f5es, diariamente, somos\u00a0 expostos \u00e0 <br \/>N-nitrosaminas.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8ab2df4 elementor-widget elementor-widget-text-editor\" data-id=\"8ab2df4\" data-element_type=\"widget\" data-settings=\"{&quot;ultimate_floating_fx_translate_y&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p style=\"margin-bottom: 20px;font-family: Roboto, sans-serif;text-align: left\"><span style=\"letter-spacing: -0.2px\">FDA (<span style=\"color: #003366\"><strong><em><a style=\"color: #003366\" href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">Food and Drug Administration<\/a><\/em><\/strong><\/span>),<\/span><span style=\"letter-spacing: -0.2px\"> EMA (<span style=\"color: #003366\"><strong><em><a style=\"color: #003366\" href=\"https:\/\/www.ema.europa.eu\/en\" target=\"_blank\" rel=\"noopener\">European Medicines Agency<\/a><\/em><\/strong><\/span>)<\/span><span style=\"letter-spacing: -0.2px\"> e <span style=\"color: #003366\"><strong><a style=\"color: #003366\" href=\"https:\/\/www.gov.br\/anvisa\/pt-br\" target=\"_blank\" rel=\"noopener\">Anvisa<\/a><\/strong><\/span><\/span><span style=\"letter-spacing: -0.2px\"> j\u00e1 emitiram resolu\u00e7\u00f5es acerca dessa pol\u00eamica. No Brasil, atualmente, passa a valer a <span style=\"color: #003366\"><strong><a style=\"color: #003366\" href=\"https:\/\/www.in.gov.br\/en\/web\/dou\/-\/resolucao-rdc-n-494-de-15-de-abril-de-2021-315224985\" target=\"_blank\" rel=\"noopener\">RDC 494\/2021 <\/a><\/strong><\/span><\/span><span style=\"letter-spacing: -0.2px\">desde abril deste ano. A Ag\u00eancia vem trabalhando para o controle e regula\u00e7\u00e3o desses compostos nas atividades da ind\u00fastria, fornecendo informa\u00e7\u00f5es e orienta\u00e7\u00f5es importantes aos fabricantes.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-55c8521 elementor-widget elementor-widget-text-editor\" data-id=\"55c8521\" data-element_type=\"widget\" data-settings=\"{&quot;ultimate_floating_fx_translate_y&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Neste artigo, abordaremos o que s\u00e3o as N-nitrosaminas, sua estrutura, onde s\u00e3o encontradas e de onde vem, a import\u00e2ncia da sua retirada no mercado e como a Anvisa est\u00e1 lidando com isso. Ent\u00e3o, se for do seu interesse ou tiver alguma d\u00favida sobre o tema, nos acompanhe nessa leitura, pois separamos os pontos mais importantes para quem quer dominar o assunto.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a54f317 elementor-widget elementor-widget-spacer\" data-id=\"a54f317\" data-element_type=\"widget\" data-settings=\"{&quot;ultimate_floating_fx_translate_y&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 05-08-2024 *\/\n.elementor-column .elementor-spacer-inner{height:var(--spacer-size)}.e-con{--container-widget-width:100%}.e-con-inner>.elementor-widget-spacer,.e-con>.elementor-widget-spacer{width:var(--container-widget-width,var(--spacer-size));--align-self:var(--container-widget-align-self,initial);--flex-shrink:0}.e-con-inner>.elementor-widget-spacer>.elementor-widget-container,.e-con>.elementor-widget-spacer>.elementor-widget-container{height:100%;width:100%}.e-con-inner>.elementor-widget-spacer>.elementor-widget-container>.elementor-spacer,.e-con>.elementor-widget-spacer>.elementor-widget-container>.elementor-spacer{height:100%}.e-con-inner>.elementor-widget-spacer>.elementor-widget-container>.elementor-spacer>.elementor-spacer-inner,.e-con>.elementor-widget-spacer>.elementor-widget-container>.elementor-spacer>.elementor-spacer-inner{height:var(--container-widget-height,var(--spacer-size))}.e-con-inner>.elementor-widget-spacer.elementor-widget-empty,.e-con>.elementor-widget-spacer.elementor-widget-empty{position:relative;min-height:22px;min-width:22px}.e-con-inner>.elementor-widget-spacer.elementor-widget-empty .elementor-widget-empty-icon,.e-con>.elementor-widget-spacer.elementor-widget-empty .elementor-widget-empty-icon{position:absolute;top:0;bottom:0;left:0;right:0;margin:auto;padding:0;width:22px;height:22px}<\/style>\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\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-6cf2c07 elementor-widget elementor-widget-image\" data-id=\"6cf2c07\" data-element_type=\"widget\" data-settings=\"{&quot;ultimate_floating_fx_translate_y&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 05-08-2024 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"640\" height=\"361\" src=\"https:\/\/insilicall.com\/wp-content\/uploads\/2021\/08\/Capa-nitrosaminas-1-mudar-1024x577.png\" class=\"attachment-large size-large wp-image-9129\" alt=\"n-nitrosaminas: toxicologia regulat\u00f3ria e novas diretrizes\" srcset=\"https:\/\/insilicall.com\/wp-content\/uploads\/2021\/08\/Capa-nitrosaminas-1-mudar-1024x577.png 1024w, https:\/\/insilicall.com\/wp-content\/uploads\/2021\/08\/Capa-nitrosaminas-1-mudar-300x169.png 300w, https:\/\/insilicall.com\/wp-content\/uploads\/2021\/08\/Capa-nitrosaminas-1-mudar-768x433.png 768w, https:\/\/insilicall.com\/wp-content\/uploads\/2021\/08\/Capa-nitrosaminas-1-mudar-1536x865.png 1536w, https:\/\/insilicall.com\/wp-content\/uploads\/2021\/08\/Capa-nitrosaminas-1-mudar.png 1640w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/>\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-959b049 elementor-widget elementor-widget-spacer\" data-id=\"959b049\" data-element_type=\"widget\" data-settings=\"{&quot;ultimate_floating_fx_translate_y&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\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-be09bc1 elementor-widget elementor-widget-text-editor\" data-id=\"be09bc1\" data-element_type=\"widget\" data-settings=\"{&quot;ultimate_floating_fx_translate_y&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<blockquote><h5>As<span style=\"color: #1a1b1e;font-family: Roboto, sans-serif;font-size: 18px;font-weight: 900;letter-spacing: -0.2px;text-align: justify\"> N-nitrosaminas, constituem uma classe de compostos caracterizados pela liga\u00e7\u00e3o de um grupo nitroso (-N=O) a um grupo funcional amina (&gt;N-), os N-nitrosos. Dentre os compostos dessa classe, alguns s\u00e3o considerados carcin\u00f3genos e podem apresentar a\u00e7\u00f5es teratog\u00eanicas, genot\u00f3xicas e mutag\u00eanicas em humanos e animais.<\/span><\/h5><\/blockquote>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-977deaa elementor-widget elementor-widget-text-editor\" data-id=\"977deaa\" data-element_type=\"widget\" data-settings=\"{&quot;ultimate_floating_fx_translate_y&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p style=\"font-family: Roboto, sans-serif;text-align: left\"><span style=\"letter-spacing: -0.2px\">Em 1954 uma dupla de cientistas ingleses, John Barnes e Peter Magee, reportaram a associa\u00e7\u00e3o entre: danos hep\u00e1ticos em ratos e a N-nitrosodimetilamina (NDMA), observa\u00e7\u00e3o in\u00e9dita para a \u00e9poca. Em 1956, apenas dois anos depois, estes mesmos pesquisadores confirmaram a indu\u00e7\u00e3o de tumores hep\u00e1ticos em ratos, alimentados por ra\u00e7\u00e3o enriquecida com nitritos. Tamb\u00e9m descobriram que outros compostos N-nitrosos eram a causa do aparecimento de c\u00e2ncer no f\u00edgado, pulm\u00f5es e de intoxica\u00e7\u00f5es alimentares potencialmente fatais. Atraindo a aten\u00e7\u00e3o de toda comunidade cient\u00edfica para os compostos N-nitrosos.<\/span><\/p><p style=\"font-family: Roboto, sans-serif;text-align: left\">A partir de ent\u00e3o, as N-nitrosaminas tornaram-se objeto de intensos estudos toxicol\u00f3gicos. Elas podem estar presentes em uma grande variedade de produtos como alimentos defumados e grelhados, latic\u00ednios e vegetais; bebidas; amostras biol\u00f3gicas como saliva, sangue e tecidos; agrot\u00f3xicos; produtos advindos de borracha; amostras ambientais como solo, \u00e1gua, efluentes e ar; cosm\u00e9ticos, medicamentos como IFAs dentre outros.\u00a0<\/p><p style=\"margin-bottom: 20px;font-family: Roboto, sans-serif;text-align: left\">As N-nitrosaminas s\u00e3o geralmente formadas ou sintetizadas pela rea\u00e7\u00e3o de uma amina (secund\u00e1ria, terci\u00e1ria ou quatern\u00e1ria) com agentes nitrosantes, como sais de nitrito em condi\u00e7\u00f5es \u00e1cidas ou \u00e1cido nitroso, do tipo NOx. Hoje, sabe-se que seus agentes formadores podem ter origens diversas, como excipientes e solventes. <span style=\"color: #003366\"><strong><a style=\"color: #003366\" href=\"https:\/\/insilicall.com\/controle-impurezas-nitrosaminas-medicamentos\/\">Cliquei aqui<\/a><\/strong><\/span> para se aprofundar mais no tema.<\/p><p style=\"margin-bottom: 20px;font-family: Roboto, sans-serif;text-align: left\">Para se aprofundar a respeito da quimica das nitrosaminas, seus procursores, estrutura, forma\u00e7\u00e3o e bioativa\u00e7\u00e3o; <span style=\"color: #003366\"><a style=\"color: #003366\" href=\"https:\/\/insilicall.com\/a-quimica-das-nitrosaminas\/\"><strong>clique aqui<\/strong><\/a><\/span> e acesse esse artigo atualizado.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d8d9698 elementor-widget elementor-widget-image\" data-id=\"d8d9698\" data-element_type=\"widget\" data-settings=\"{&quot;ultimate_floating_fx_translate_y&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" 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<img decoding=\"async\" width=\"640\" height=\"264\" src=\"https:\/\/insilicall.com\/wp-content\/uploads\/2021\/08\/nitrosaminas3d.png\" class=\"attachment-large size-large wp-image-9071\" alt=\"Sintese de n-nitrosaminas\" srcset=\"https:\/\/insilicall.com\/wp-content\/uploads\/2021\/08\/nitrosaminas3d.png 678w, https:\/\/insilicall.com\/wp-content\/uploads\/2021\/08\/nitrosaminas3d-300x124.png 300w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/>\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-10d402 elementor-widget elementor-widget-text-editor\" data-id=\"10d402\" data-element_type=\"widget\" data-settings=\"{&quot;ultimate_floating_fx_translate_y&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"letter-spacing: -0.2px\">Elas s\u00e3o absorvidas principalmente pelo trato gastrintestinal, podendo ser absorvidas atrav\u00e9s <br \/>da pele, ainda que\u00a0 com menor\u00a0 rapidez e porcentagem. N\u00e3o s\u00e3o bioacumuladas e requerem ativa\u00e7\u00e3o metab\u00f3lica para exercerem sua a\u00e7\u00e3o mutag\u00eanica e carcinog\u00eanica. O principal \u00f3rg\u00e3o de biotransforma\u00e7\u00e3o das nitrosaminas \u00e9 o f\u00edgado, outros tecidos tamb\u00e9m podem biotransformar.\u00a0<\/span><\/p><p><span style=\"font-weight: 400\">Diante do panorama toxicol\u00f3gico, \u00e9 explicado porque a preocupa\u00e7\u00e3o de \u00f3rg\u00e3os do mundo todo em retirar as N-nitrosaminas do mercado, ou reduzi-las consideravelmente. FDA, EMA<br \/>e Anvisa j\u00e1 v\u00eam se movimentando nessa dire\u00e7\u00e3o a alguns anos.<\/span><\/p><p><span style=\"font-weight: 400\">Desde 2019, a Anvisa (Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria) vem publicando resolu\u00e7\u00f5es como a <\/span><span style=\"color: #003366\"><strong><a style=\"color: #003366\" href=\"https:\/\/www.in.gov.br\/web\/dou\/-\/resolucao-rdc-n-283-de-17-de-maio-de-2019-118357341\" target=\"_blank\" rel=\"noopener\">RDC 283\/2019<\/a><\/strong><\/span><span style=\"font-weight: 400\"> a fim de estabelecer regras para investiga\u00e7\u00e3o, controle e elimina\u00e7\u00e3o das nitrosaminas. O Brasil conta agora com o Programa Especial de Monitoramento de Nitrosaminas em Medicamentos, criado pela Anvisa para aprofundar as investiga\u00e7\u00f5es sobre <br \/>a presen\u00e7a de impurezas do tipo nitrosamina em insumos farmac\u00eauticos ativos.<\/span><\/p><p><span style=\"font-weight: 400\">O foco dessa a\u00e7\u00e3o s\u00e3o os medicamentos das classes conhecidas como sartanas (do grupo BRA, bloqueadores dos receptores da angiotensina II), geralmente usados para controle de press\u00e3o alta. Desde ent\u00e3o, observou-se o aparecimento de relatos de que outros insumos farmac\u00eauticos ativos de outras classes terap\u00eauticas tamb\u00e9m s\u00e3o precursores conhecidos ou suspeitos de conterem NDMA e outras nitrosaminas tamb\u00e9m potencialmente carcinog\u00eanicas.<\/span><\/p><p><span style=\"font-weight: 400\">O programa teve in\u00edcio em Setembro de 2020 e \u00e9 coordenado pela Ag\u00eancia em parceria com o Instituto Nacional de Controle de Qualidade (INCQS\/Fiocruz). A partir de ent\u00e3o a Anvisa criou o \u201c<\/span><span style=\"color: #003366\"><strong><a style=\"color: #003366\" href=\"http:\/\/antigo.anvisa.gov.br\/documents\/10181\/6279847\/(1)Guia_50_Nitrosaminas_rev_final_para+publica%C3%A7%C3%A3o.pdf\/12af2904-e5a7-4774-9528-f4f633cac2bf\" target=\"_blank\" rel=\"noopener\">Guia sobre o Controle de Nitrosaminas em Insumos Farmac\u00eauticos Ativos e Medicamentos<\/a><\/strong><\/span><span style=\"font-weight: 400\">\u201d que expressa o entendimento da Anvisa sobre as melhores pr\u00e1ticas com rela\u00e7\u00e3o a procedimentos, rotinas e m\u00e9todos considerados adequados ao cumprimento de requisitos t\u00e9cnicos ou administrativos exigidos pelos marcos legislativo e regulat\u00f3rio da Ag\u00eancia. Este guia conta com a contribui\u00e7\u00e3o de terceiros e ainda n\u00e3o chegou \u00e0 sua vers\u00e3o definitiva, que ser\u00e1 formulada a partir de setembro de 2021.\u00a0<\/span><\/p><p><span style=\"font-weight: 400\">Para os f\u00e1rmacos do grupo ARA\/BRA (antagonistas do receptor de angiotensina II), foi estipulado que ap\u00f3s o dia 31\/12\/2021 ser\u00e1 inaceit\u00e1vel concentra\u00e7\u00f5es de nitrosaminas (acima de 0,03 ppm), segundo a resolu\u00e7\u00e3o <\/span><span style=\"color: #003366\"><strong><a style=\"color: #003366\" href=\"https:\/\/www.in.gov.br\/en\/web\/dou\/-\/resolucao-rdc-n-494-de-15-de-abril-de-2021-315224985\" target=\"_blank\" rel=\"noopener\">RDC 494\/2021<\/a><\/strong><\/span><span style=\"font-weight: 400\">. Outros medicamentos dever\u00e3o seguir o Guia acima, e provavelmente contar\u00e3o com alguma futura norma regulamentadora que restrinja a presen\u00e7a das N-nitrosaminas em sua composi\u00e7\u00e3o, fazendo com que muitas formula\u00e7\u00f5es passem por revis\u00e3o e adequa\u00e7\u00e3o ao longo dos pr\u00f3ximos anos.<\/span><\/p><p><span style=\"font-weight: 400\">Dado o grande n\u00famero de laborat\u00f3rios no pa\u00eds, quanto antes a revis\u00e3o dos medicamentos forem feitas, menos ca\u00f3tico se tornar\u00e1 o cen\u00e1rio ap\u00f3s a manifesta\u00e7\u00e3o da Anvisa liberando essa nova resolu\u00e7\u00e3o. Afinal, todos conhecem a velha lei do mercado sobre oferta e procura.<\/span><\/p><p>Conhe\u00e7a mais sobre a legisla\u00e7\u00e3o e as etapas do processo de banimento das nitrosaminas em medicamentos, lendo<strong><span style=\"color: #003366\"> <a style=\"color: #003366\" href=\"https:\/\/insilicall.com\/legislacao-anvisa-e-nitrosaminas\/\">este artigo aqui<\/a><\/span>.<\/strong> N\u00e3o perca os prazos estipulados e saiba quais RDCs foram publicadas at\u00e9 o momento, esteja em dia com a Anvisa.<\/p><p>A InsilicAll est\u00e1 prepara para atender as demandas da sua empresa, saiba<span style=\"color: #003366\"> <a style=\"color: #003366\" href=\"https:\/\/insilicall.com\/nitrosaminas-toxicologia-regulatoria-e-sanidade\/\"><strong>o que esperar de um relat\u00f3rio t\u00e9cnico-cient\u00edfico<\/strong><\/a><\/span> de alta confiabilidade e entenda como nosso <span style=\"color: #003366\"><strong><a style=\"color: #003366\" href=\"https:\/\/insilicall.com\/fluxo-insilicall-qualificacao-nitrosaminas\/\">fluxo de qualifica\u00e7\u00e3o de nitrosaminas<\/a><\/strong> <\/span>tem os diferenciais certos para voc\u00ea.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eac4a61 elementor-widget elementor-widget-text-editor\" data-id=\"eac4a61\" data-element_type=\"widget\" data-settings=\"{&quot;ultimate_floating_fx_translate_y&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p style=\"font-family: Roboto, sans-serif;text-align: left\"><span style=\"letter-spacing: -0.2px\">Em 1954 uma dupla de cientistas ingleses, John Barnes e Peter Magee, reportaram a associa\u00e7\u00e3o entre: danos hep\u00e1ticos em ratos e a N-nitrosodimetilamina (NDMA), observa\u00e7\u00e3o in\u00e9dita para a \u00e9poca. Em 1956, apenas dois anos depois, estes mesmos pesquisadores confirmaram a indu\u00e7\u00e3o de tumores hep\u00e1ticos em ratos, alimentados por ra\u00e7\u00e3o enriquecida com nitritos. Tamb\u00e9m descobriram que outros compostos N-nitrosos eram a causa do aparecimento de c\u00e2ncer no f\u00edgado, pulm\u00f5es e de intoxica\u00e7\u00f5es alimentares potencialmente fatais. Atraindo a aten\u00e7\u00e3o de toda comunidade cient\u00edfica para os compostos N-nitrosos.<\/span><\/p><p style=\"font-family: Roboto, sans-serif;text-align: left\">A partir de ent\u00e3o, as N-nitrosaminas tornaram-se objeto de intensos estudos toxicol\u00f3gicos. Elas podem estar presentes em uma grande variedade de produtos como alimentos defumados e grelhados, latic\u00ednios e vegetais; bebidas; amostras biol\u00f3gicas como saliva, sangue e tecidos; agrot\u00f3xicos; produtos advindos de borracha; amostras ambientais como solo, \u00e1gua, efluentes e ar; cosm\u00e9ticos, medicamentos como IFAs dentre outros.\u00a0<\/p><p style=\"margin-bottom: 20px;font-family: Roboto, sans-serif;text-align: left\">As N-nitrosaminas s\u00e3o geralmente formadas ou sintetizadas pela rea\u00e7\u00e3o de uma amina (secund\u00e1ria, terci\u00e1ria ou quatern\u00e1ria) com agentes nitrosantes, como sais de nitrito em condi\u00e7\u00f5es \u00e1cidas ou \u00e1cido nitroso, do tipo NOx. Hoje, sabe-se que seus agentes formadores podem ter origens diversas, como excipientes e solventes. <strong><a href=\"https:\/\/insilicall.com\/controle-impurezas-nitrosaminas-medicamentos\/\">Cliquei aqui<\/a><\/strong> para se aprofundar mais no tema.<\/p><p style=\"margin-bottom: 20px;font-family: Roboto, sans-serif;text-align: left\">Para se aprofundar a respeito da quimica das nitrosaminas, seus procursores, estrutura, forma\u00e7\u00e3o e bioativa\u00e7\u00e3o; <a href=\"https:\/\/insilicall.com\/a-quimica-das-nitrosaminas\/\"><strong>clique aqui<\/strong><\/a> e acesse esse artigo atualizado.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ceb29a8 elementor-widget-divider--separator-type-pattern elementor-widget-divider--no-spacing elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"ceb29a8\" data-element_type=\"widget\" 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.elementor-divider-separator{width:100%;min-height:var(--divider-pattern-height);-webkit-mask-size:var(--divider-pattern-size) 100%;mask-size:var(--divider-pattern-size) 100%;-webkit-mask-repeat:var(--divider-pattern-repeat);mask-repeat:var(--divider-pattern-repeat);background-color:var(--divider-color);-webkit-mask-image:var(--divider-pattern-url);mask-image:var(--divider-pattern-url)}.elementor-widget-divider--no-spacing{--divider-pattern-size:auto}.elementor-widget-divider--bg-round{--divider-pattern-repeat:round}.rtl .elementor-widget-divider .elementor-divider__text{direction:rtl}.e-con-inner>.elementor-widget-divider,.e-con>.elementor-widget-divider{width:var(--container-widget-width,100%);--flex-grow:var(--container-widget-flex-grow)}<\/style>\t\t<div class=\"elementor-divider\" style=\"--divider-pattern-url: url(&quot;data:image\/svg+xml,%3Csvg xmlns=&#039;http:\/\/www.w3.org\/2000\/svg&#039; preserveAspectRatio=&#039;xMidYMid meet&#039; overflow=&#039;visible&#039; height=&#039;100%&#039; viewBox=&#039;0 0 126 26&#039; fill=&#039;black&#039; stroke=&#039;none&#039;%3E%3Cpath d=&#039;M10.7,6l2.5,2.6l-4,4.3l4,5.4l-2.5,1.9l-4.5-5.2l-3.9,4.2L0.7,17L4,13.1L0,8.6l2.3-1.3l3.9,3.9L10.7,6z M23.9,6.6l4.2,4.5L32,7.2l2.3,1.3l-4,4.5l3.2,3.9L32,19.1l-3.9-3.3l-4.5,4.3l-2.5-1.9l4.4-5.1l-4.2-3.9L23.9,6.6zM73.5,6L76,8.6l-4,4.3l4,5.4l-2.5,1.9l-4.5-5.2l-3.9,4.2L63.5,17l4.1-4.7L63.5,8l2.3-1.3l4.1,3.6L73.5,6z M94,6l2.5,2.6l-4,4.3l4,5.4L94,20.1l-3.9-5l-3.9,4.2L84,17l3.2-3.9L84,8.6l2.3-1.3l3.2,3.9L94,6z M106.9,6l4.5,5.1l3.9-3.9l2.3,1.3l-4,4.5l3.2,3.9l-1.6,2.1l-3.9-4.2l-4.5,5.2l-2.5-1.9l4-5.4l-4-4.3L106.9,6z M53.1,6l2.5,2.6l-4,4.3l4,4.6l-2.5,1.9l-4.5-4.5l-3.5,4.5L43.1,17l3.2-3.9l-4-4.5l2.3-1.3l3.9,3.9L53.1,6z&#039;\/%3E%3C\/svg%3E&quot;);\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\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-c5896ae elementor-widget elementor-widget-text-editor\" data-id=\"c5896ae\" data-element_type=\"widget\" data-settings=\"{&quot;ultimate_floating_fx_translate_y&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><em><strong><span style=\"font-family: Roboto, sans-serif;letter-spacing: -0.2px;text-align: justify\">Surgiu alguma d\u00favida ou quer contribuir para o assunto?! Deixe seu coment\u00e1rio abaixo.<\/span><\/strong><\/em><\/p><p><em><strong><span style=\"font-family: Roboto, sans-serif;letter-spacing: -0.2px;text-align: justify\">Nos acompanhe e receba mais informa\u00e7\u00f5es sobre esses e outros temas. E caso esteja em busca de solucionar essa demanda na sua empresa, <span style=\"color: #003366\"><a style=\"color: #003366\" href=\"https:\/\/insilicall.com\/fale-com-especialistas-regulatorio-nitrosaminas\/\">entre em contato<\/a><\/span> ou confira <a href=\"https:\/\/insilicall.com\/produtos-e-servicos-insilicall\/\"><span style=\"color: #003366\">nossas solu\u00e7\u00f5es<\/span>.<\/a><\/span><\/strong><\/em><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b599041 elementor-widget-divider--separator-type-pattern elementor-widget-divider--no-spacing elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"b599041\" data-element_type=\"widget\" data-settings=\"{&quot;ultimate_floating_fx_translate_y&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\" style=\"--divider-pattern-url: url(&quot;data:image\/svg+xml,%3Csvg xmlns=&#039;http:\/\/www.w3.org\/2000\/svg&#039; preserveAspectRatio=&#039;xMidYMid meet&#039; overflow=&#039;visible&#039; height=&#039;100%&#039; viewBox=&#039;0 0 126 26&#039; fill=&#039;black&#039; stroke=&#039;none&#039;%3E%3Cpath d=&#039;M10.7,6l2.5,2.6l-4,4.3l4,5.4l-2.5,1.9l-4.5-5.2l-3.9,4.2L0.7,17L4,13.1L0,8.6l2.3-1.3l3.9,3.9L10.7,6z M23.9,6.6l4.2,4.5L32,7.2l2.3,1.3l-4,4.5l3.2,3.9L32,19.1l-3.9-3.3l-4.5,4.3l-2.5-1.9l4.4-5.1l-4.2-3.9L23.9,6.6zM73.5,6L76,8.6l-4,4.3l4,5.4l-2.5,1.9l-4.5-5.2l-3.9,4.2L63.5,17l4.1-4.7L63.5,8l2.3-1.3l4.1,3.6L73.5,6z M94,6l2.5,2.6l-4,4.3l4,5.4L94,20.1l-3.9-5l-3.9,4.2L84,17l3.2-3.9L84,8.6l2.3-1.3l3.2,3.9L94,6z M106.9,6l4.5,5.1l3.9-3.9l2.3,1.3l-4,4.5l3.2,3.9l-1.6,2.1l-3.9-4.2l-4.5,5.2l-2.5-1.9l4-5.4l-4-4.3L106.9,6z M53.1,6l2.5,2.6l-4,4.3l4,4.6l-2.5,1.9l-4.5-4.5l-3.5,4.5L43.1,17l3.2-3.9l-4-4.5l2.3-1.3l3.9,3.9L53.1,6z&#039;\/%3E%3C\/svg%3E&quot;);\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\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-2fe27ea elementor-widget elementor-widget-text-editor\" data-id=\"2fe27ea\" data-element_type=\"widget\" data-settings=\"{&quot;ultimate_floating_fx_translate_y&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>Indice de links utilizados:<\/strong><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fd9b2e9 elementor-align-left elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"fd9b2e9\" data-element_type=\"widget\" data-settings=\"{&quot;ultimate_floating_fx_translate_y&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/insilicall.com\/wp-content\/plugins\/elementor\/assets\/css\/widget-icon-list.min.css\">\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/insilicall.com\/controle-impurezas-nitrosaminas-medicamentos\/\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-double-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M224.3 273l-136 136c-9.4 9.4-24.6 9.4-33.9 0l-22.6-22.6c-9.4-9.4-9.4-24.6 0-33.9l96.4-96.4-96.4-96.4c-9.4-9.4-9.4-24.6 0-33.9L54.3 103c9.4-9.4 24.6-9.4 33.9 0l136 136c9.5 9.4 9.5 24.6.1 34zm192-34l-136-136c-9.4-9.4-24.6-9.4-33.9 0l-22.6 22.6c-9.4 9.4-9.4 24.6 0 33.9l96.4 96.4-96.4 96.4c-9.4 9.4-9.4 24.6 0 33.9l22.6 22.6c9.4 9.4 24.6 9.4 33.9 0l136-136c9.4-9.2 9.4-24.4 0-33.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Controle de impurezas de nitrosaminas em medicamentos<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/insilicall.com\/legislacao-anvisa-e-nitrosaminas\/\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-double-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M224.3 273l-136 136c-9.4 9.4-24.6 9.4-33.9 0l-22.6-22.6c-9.4-9.4-9.4-24.6 0-33.9l96.4-96.4-96.4-96.4c-9.4-9.4-9.4-24.6 0-33.9L54.3 103c9.4-9.4 24.6-9.4 33.9 0l136 136c9.5 9.4 9.5 24.6.1 34zm192-34l-136-136c-9.4-9.4-24.6-9.4-33.9 0l-22.6 22.6c-9.4 9.4-9.4 24.6 0 33.9l96.4 96.4-96.4 96.4c-9.4 9.4-9.4 24.6 0 33.9l22.6 22.6c9.4 9.4 24.6 9.4 33.9 0l136-136c9.4-9.2 9.4-24.4 0-33.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Leisla\u00e7\u00e3o, ANVISA e nitrosaminas<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/insilicall.com\/nitrosaminas-toxicologia-regulatoria-e-sanidade\/\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-double-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M224.3 273l-136 136c-9.4 9.4-24.6 9.4-33.9 0l-22.6-22.6c-9.4-9.4-9.4-24.6 0-33.9l96.4-96.4-96.4-96.4c-9.4-9.4-9.4-24.6 0-33.9L54.3 103c9.4-9.4 24.6-9.4 33.9 0l136 136c9.5 9.4 9.5 24.6.1 34zm192-34l-136-136c-9.4-9.4-24.6-9.4-33.9 0l-22.6 22.6c-9.4 9.4-9.4 24.6 0 33.9l96.4 96.4-96.4 96.4c-9.4 9.4-9.4 24.6 0 33.9l22.6 22.6c9.4 9.4 24.6 9.4 33.9 0l136-136c9.4-9.2 9.4-24.4 0-33.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Nitrosaminas, toxicologia regulat\u00f3ria e sanidade.<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/insilicall.com\/fluxo-insilicall-qualificacao-nitrosaminas\/\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-double-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M224.3 273l-136 136c-9.4 9.4-24.6 9.4-33.9 0l-22.6-22.6c-9.4-9.4-9.4-24.6 0-33.9l96.4-96.4-96.4-96.4c-9.4-9.4-9.4-24.6 0-33.9L54.3 103c9.4-9.4 24.6-9.4 33.9 0l136 136c9.5 9.4 9.5 24.6.1 34zm192-34l-136-136c-9.4-9.4-24.6-9.4-33.9 0l-22.6 22.6c-9.4 9.4-9.4 24.6 0 33.9l96.4 96.4-96.4 96.4c-9.4 9.4-9.4 24.6 0 33.9l22.6 22.6c9.4 9.4 24.6 9.4 33.9 0l136-136c9.4-9.2 9.4-24.4 0-33.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Fluxo InsilicAll para qualifica\u00e7\u00e3o de nitrosaminas<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/insilicall.com\/a-quimica-das-nitrosaminas\/\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-double-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M224.3 273l-136 136c-9.4 9.4-24.6 9.4-33.9 0l-22.6-22.6c-9.4-9.4-9.4-24.6 0-33.9l96.4-96.4-96.4-96.4c-9.4-9.4-9.4-24.6 0-33.9L54.3 103c9.4-9.4 24.6-9.4 33.9 0l136 136c9.5 9.4 9.5 24.6.1 34zm192-34l-136-136c-9.4-9.4-24.6-9.4-33.9 0l-22.6 22.6c-9.4 9.4-9.4 24.6 0 33.9l96.4 96.4-96.4 96.4c-9.4 9.4-9.4 24.6 0 33.9l22.6 22.6c9.4 9.4 24.6 9.4 33.9 0l136-136c9.4-9.2 9.4-24.4 0-33.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">A quimica das nitrosaminas<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.in.gov.br\/web\/dou\/-\/resolucao-rdc-n-283-de-17-de-maio-de-2019-118357341\" target=\"_blank\" rel=\"noopener\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-double-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M224.3 273l-136 136c-9.4 9.4-24.6 9.4-33.9 0l-22.6-22.6c-9.4-9.4-9.4-24.6 0-33.9l96.4-96.4-96.4-96.4c-9.4-9.4-9.4-24.6 0-33.9L54.3 103c9.4-9.4 24.6-9.4 33.9 0l136 136c9.5 9.4 9.5 24.6.1 34zm192-34l-136-136c-9.4-9.4-24.6-9.4-33.9 0l-22.6 22.6c-9.4 9.4-9.4 24.6 0 33.9l96.4 96.4-96.4 96.4c-9.4 9.4-9.4 24.6 0 33.9l22.6 22.6c9.4 9.4 24.6 9.4 33.9 0l136-136c9.4-9.2 9.4-24.4 0-33.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">RDC 283\/2019<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.in.gov.br\/en\/web\/dou\/-\/resolucao-rdc-n-494-de-15-de-abril-de-2021-315224985\" target=\"_blank\" rel=\"noopener\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-double-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M224.3 273l-136 136c-9.4 9.4-24.6 9.4-33.9 0l-22.6-22.6c-9.4-9.4-9.4-24.6 0-33.9l96.4-96.4-96.4-96.4c-9.4-9.4-9.4-24.6 0-33.9L54.3 103c9.4-9.4 24.6-9.4 33.9 0l136 136c9.5 9.4 9.5 24.6.1 34zm192-34l-136-136c-9.4-9.4-24.6-9.4-33.9 0l-22.6 22.6c-9.4 9.4-9.4 24.6 0 33.9l96.4 96.4-96.4 96.4c-9.4 9.4-9.4 24.6 0 33.9l22.6 22.6c9.4 9.4 24.6 9.4 33.9 0l136-136c9.4-9.2 9.4-24.4 0-33.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">RDC 494\/2021<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"http:\/\/antigo.anvisa.gov.br\/documents\/10181\/6279847\/(1)Guia_50_Nitrosaminas_rev_final_para+publica%C3%A7%C3%A3o.pdf\/12af2904-e5a7-4774-9528-f4f633cac2bf\" target=\"_blank\" rel=\"noopener\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-double-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M224.3 273l-136 136c-9.4 9.4-24.6 9.4-33.9 0l-22.6-22.6c-9.4-9.4-9.4-24.6 0-33.9l96.4-96.4-96.4-96.4c-9.4-9.4-9.4-24.6 0-33.9L54.3 103c9.4-9.4 24.6-9.4 33.9 0l136 136c9.5 9.4 9.5 24.6.1 34zm192-34l-136-136c-9.4-9.4-24.6-9.4-33.9 0l-22.6 22.6c-9.4 9.4-9.4 24.6 0 33.9l96.4 96.4-96.4 96.4c-9.4 9.4-9.4 24.6 0 33.9l22.6 22.6c9.4 9.4 24.6 9.4 33.9 0l136-136c9.4-9.2 9.4-24.4 0-33.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Guia 50: sobre o controle de nitrosaminas em insumos farmac\u00eauticos ativos e medicamentos<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\" target=\"_blank\" rel=\"noopener\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-double-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M224.3 273l-136 136c-9.4 9.4-24.6 9.4-33.9 0l-22.6-22.6c-9.4-9.4-9.4-24.6 0-33.9l96.4-96.4-96.4-96.4c-9.4-9.4-9.4-24.6 0-33.9L54.3 103c9.4-9.4 24.6-9.4 33.9 0l136 136c9.5 9.4 9.5 24.6.1 34zm192-34l-136-136c-9.4-9.4-24.6-9.4-33.9 0l-22.6 22.6c-9.4 9.4-9.4 24.6 0 33.9l96.4 96.4-96.4 96.4c-9.4 9.4-9.4 24.6 0 33.9l22.6 22.6c9.4 9.4 24.6 9.4 33.9 0l136-136c9.4-9.2 9.4-24.4 0-33.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">ANVISA - Ag\u00eancia Nacional de Vigil\u00eancia Sanit\u00e1ria<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.ema.europa.eu\/en\" target=\"_blank\" rel=\"noopener\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-double-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M224.3 273l-136 136c-9.4 9.4-24.6 9.4-33.9 0l-22.6-22.6c-9.4-9.4-9.4-24.6 0-33.9l96.4-96.4-96.4-96.4c-9.4-9.4-9.4-24.6 0-33.9L54.3 103c9.4-9.4 24.6-9.4 33.9 0l136 136c9.5 9.4 9.5 24.6.1 34zm192-34l-136-136c-9.4-9.4-24.6-9.4-33.9 0l-22.6 22.6c-9.4 9.4-9.4 24.6 0 33.9l96.4 96.4-96.4 96.4c-9.4 9.4-9.4 24.6 0 33.9l22.6 22.6c9.4 9.4 24.6 9.4 33.9 0l136-136c9.4-9.2 9.4-24.4 0-33.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">EMA - European Medicines Agency<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-angle-double-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M224.3 273l-136 136c-9.4 9.4-24.6 9.4-33.9 0l-22.6-22.6c-9.4-9.4-9.4-24.6 0-33.9l96.4-96.4-96.4-96.4c-9.4-9.4-9.4-24.6 0-33.9L54.3 103c9.4-9.4 24.6-9.4 33.9 0l136 136c9.5 9.4 9.5 24.6.1 34zm192-34l-136-136c-9.4-9.4-24.6-9.4-33.9 0l-22.6 22.6c-9.4 9.4-9.4 24.6 0 33.9l96.4 96.4-96.4 96.4c-9.4 9.4-9.4 24.6 0 33.9l22.6 22.6c9.4 9.4 24.6 9.4 33.9 0l136-136c9.4-9.2 9.4-24.4 0-33.8z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">FDA - Food and Drugs Administration<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eda2d9b elementor-widget-divider--separator-type-pattern elementor-widget-divider--no-spacing elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"eda2d9b\" data-element_type=\"widget\" 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data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400\">Somos a primeira empresa LATAM que empodera a ind\u00fastria farmac\u00eautica em seus desafios de drug discovery e em toxicologia regulat\u00f3ria aplicando IA e automa\u00e7\u00e3o biol\u00f3gica. Com nosso modelo SaaS aumentamos a taxa de sucesso de nossos clientes levando medicamentos inovadores para os pacientes de forma mais r\u00e1pida e garantindo a seguran\u00e7a toxicol\u00f3gica de sua produ\u00e7\u00e3o. Nossa miss\u00e3o de entregar a melhor tecnologia com o menor impacto (ESG) nos permite garantir para nossos clientes a otimiza\u00e7\u00e3o de tempo, custos e experimenta\u00e7\u00e3o animal em seus processos.<\/span><\/p><p><span style=\"font-weight: 400\">Trabalhamos para aumentar a taxa de sucesso em levar medicamentos inovadores para as necessidades dos pacientes, diminuindo o cronograma, os custos e o tempo para que um novo produto chegue \u00e0 sociedade. Para isso, nossa empresa integra IA, computa\u00e7\u00e3o e automa\u00e7\u00e3o biol\u00f3gica para acelerar o design de novas mol\u00e9culas e prote\u00ednas terap\u00eauticas.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>As N-nitrosaminas possuem elevada toxicidade, gerando grave risco \u00e0 sa\u00fade. A toxicologia regulat\u00f3ria faz a ponte entre laborat\u00f3rios e a Anvisa.<\/p>\n","protected":false},"author":6,"featured_media":10682,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rank_math_lock_modified_date":false,"footnotes":""},"categories":[110,79],"tags":[78,116,115,111,124,112,117,61,113,123],"class_list":["post-9059","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-atualidades","category-noticias","tag-anvisa","tag-farmacos","tag-ifas","tag-n-nitrosaminas","tag-nitrosamina","tag-nitrosaminas","tag-nitrosamines","tag-pharmaceutical-rd-pt-br","tag-toxicologia","tag-toxicologia-regulatoria","no-social-count","single-post-item mb40"],"_links":{"self":[{"href":"https:\/\/insilicall.com\/wp-json\/wp\/v2\/posts\/9059"}],"collection":[{"href":"https:\/\/insilicall.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/insilicall.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/insilicall.com\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/insilicall.com\/wp-json\/wp\/v2\/comments?post=9059"}],"version-history":[{"count":98,"href":"https:\/\/insilicall.com\/wp-json\/wp\/v2\/posts\/9059\/revisions"}],"predecessor-version":[{"id":15224,"href":"https:\/\/insilicall.com\/wp-json\/wp\/v2\/posts\/9059\/revisions\/15224"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/insilicall.com\/wp-json\/wp\/v2\/media\/10682"}],"wp:attachment":[{"href":"https:\/\/insilicall.com\/wp-json\/wp\/v2\/media?parent=9059"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/insilicall.com\/wp-json\/wp\/v2\/categories?post=9059"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/insilicall.com\/wp-json\/wp\/v2\/tags?post=9059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}