{"id":4211,"date":"2022-10-13T12:41:17","date_gmt":"2022-10-13T16:41:17","guid":{"rendered":"https:\/\/web.uri.edu\/pdi\/?page_id=4211"},"modified":"2026-10-23T11:20:41","modified_gmt":"2026-10-23T15:20:41","slug":"analyticalservices","status":"publish","type":"page","link":"https:\/\/web.uri.edu\/pdi\/analyticalservices\/","title":{"rendered":"Analytical Services"},"content":{"rendered":"<section class=\"cl-wrapper cl-hero-wrapper\"><div class=\"cl-hero fullwidth   cl-has-accessibility-controls\"><div class=\"cl-hero-proper\"><div class=\"overlay\"><div class=\"block\"><h1>Reliable Science.\nConfident Decisions.<\/h1><\/div><\/div><div class=\"still\" style=\"background-image:url(https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/pdianalytical2-scaled.jpg);background-position:50% 26%;\"><\/div><div class=\"cl-accessibility-controls-container\"><div class=\"cl-accessibility-controls\"><div class=\"cl-accessibility-icon\" title=\"Accessibility controls\">Accessibility controls<\/div><div class=\"cl-accessibility-control cl-accessibility-motion-control cl-accessibility-control-hidden\"><div class=\"cl-accessibility-control-default\"><div class=\"cl-accessibility-control-button\" title=\"Pause motion\">Pause motion<\/div><div class=\"cl-accessibility-control-label\">Motion: <span class=\"cl-accessibility-syntax\">On<\/span><\/div><\/div><div class=\"cl-accessibility-control-alternate\"><div class=\"cl-accessibility-control-button\" title=\"Play motion\">Play motion<\/div><div class=\"cl-accessibility-control-label\">Motion: <span class=\"cl-accessibility-syntax\">Off<\/span><\/div><\/div><\/div><div class=\"cl-accessibility-control cl-accessibility-contrast-control\"><div class=\"cl-accessibility-control-default\"><div class=\"cl-accessibility-control-button\" title=\"Increase text contrast\">Increase text contrast<\/div><div class=\"cl-accessibility-control-label\">Contrast: <span class=\"cl-accessibility-syntax\">Standard<\/span><\/div><\/div><div class=\"cl-accessibility-control-alternate\"><div class=\"cl-accessibility-control-button\" title=\"Reset text contrast\">Reset text contrast<\/div><div class=\"cl-accessibility-control-label\">Contrast: <span class=\"cl-accessibility-syntax\">High<\/span><\/div><\/div><\/div><div class=\"cl-accessibility-system-setting\"><div class=\"cl-accessibility-toggle\" title=\"Apply my preferences site-wide\"><\/div><div class=\"cl-accessibility-toggle-label\">Apply site-wide<\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n\n\n<h3 class=\"wp-block-heading\"><strong>Analytical Development &amp; Pharmaceutical Consulting<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The Pharmaceutical Development Institute (PDI) provides specialized analytical development, testing, and consulting services to support pharmaceutical research and drug development. Drawing on extensive pharmaceutical industry experience in analytical development, cGMP laboratory operations, method validation, and stability programs, our scientists provide practical, scientifically rigorous solutions to complex analytical challenges.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">PDI combines industry expertise, advanced analytical technologies, and access to the University of Rhode Island&#8217;s research resources to help pharmaceutical and biotechnology companies advance their drug development programs efficiently and cost-effectively.&nbsp;<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Analytical Method Development &amp; Optimization<\/strong>&nbsp;<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">PDI specializes in the development of robust, fit-for-purpose analytical methods for drug substances and drug products. Our approach incorporates modern analytical development principles, including Analytical Quality by Design (AQbD), Design of Experiments (DoE), and the enhanced analytical procedure development concepts described in ICH Q14.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Our capabilities include:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Analytical method development, evaluation, qualification, and optimization&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>DoE-based method development and optimization using Fusion software&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Application of ICH Q14 principles to analytical procedure development&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Development and optimization of stability-indicating analytical methods&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Forced degradation studies to assess degradation pathways and method specificity&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Analytical method troubleshooting and performance improvement&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Analytical testing to support drug substance characterization and formulation development&nbsp;<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Stability &amp; Degradation Studies<\/strong>&nbsp;<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">PDI provides stability and degradation studies to support early-stage drug development, formulation optimization, and assessment of pharmaceutical product quality.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Services include:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Accelerated and controlled-condition stability studies&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Forced degradation studies&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Drug substance and drug product stability evaluation&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Stability-indicating analytical method development&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Excipient compatibility studies&nbsp;<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Investigation of degradation products and stability-related analytical challenges&nbsp;<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Pharmaceutical Analytical Consulting<\/strong>&nbsp;<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">PDI offers specialized scientific and technical consulting informed by extensive pharmaceutical industry experience in cGMP analytical testing, laboratory management, method development and validation, and drug substance and drug product stability programs.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Our scientists work collaboratively with pharmaceutical and biotechnology companies to develop effective analytical strategies, solve technical challenges, and provide expert guidance for analytical activities performed internally or through contracted laboratories.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Consulting services include:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Analytical development strategies and method lifecycle management&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Technical guidance on ICH Q14, ICH Q2(R2), and analytical method validation approaches&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Analytical method qualification and validation strategy development&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Independent technical review of analytical methods, protocols, and data&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Analytical method troubleshooting and investigation of method performance issues&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Technical support for analytical method transfer to contract laboratories&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Scientific guidance and collaboration with contracted testing laboratories&nbsp;<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Stability study design, analytical strategy, and interpretation of stability data&nbsp;<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Analytical Testing &amp; Instrumentation<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">PDI maintains analytical instrumentation and pharmaceutical testing capabilities to support method development, product characterization, and stability studies.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Core capabilities include:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>High-performance and ultra-performance liquid chromatography (HPLC and UPLC)&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Gas chromatography (GC)&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Dissolution testing&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Disintegration testing&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Moisture determination&nbsp;<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Controlled-temperature and humidity stability chambers&nbsp;<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Advanced Analytical Capabilities Through URI Core Facilities<\/strong>&nbsp;<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">PDI&#8217;s capabilities are complemented by access to sophisticated analytical instrumentation and specialized scientific expertise through the University of Rhode Island&#8217;s shared research core facilities.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Depending on project requirements and facility availability, these resources provide opportunities to incorporate advanced analytical technologies, including:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Liquid chromatography\u2013mass spectrometry (LC-MS\/MS)&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Gas chromatography\u2013mass spectrometry (GC-MS\/MS)&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Inductively coupled plasma mass spectrometry (ICP-MS)&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Advanced spectroscopic and chromatographic techniques&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Differential scanning calorimetry (DSC)&nbsp;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Additional specialized analytical and materials characterization capabilities&nbsp;<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">By leveraging PDI&#8217;s pharmaceutical development expertise and URI&#8217;s broader research infrastructure, we can offer flexible, collaborative approaches to challenging analytical development projects.&nbsp;<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\" \/>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<h1 class=\"wp-block-heading\">Partner with PDI<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">Whether developing a new analytical method, optimizing a formulation, investigating stability concerns, or seeking expert technical guidance for work performed at a contract laboratory, PDI provides the scientific expertise and collaborative approach needed to support your pharmaceutical development program.&nbsp;<\/p>\n\n\n<a class=\"cl-button   prominent\" href=\"https:\/\/web.uri.edu\/pdi\/partner\/\" title=\"\">DISCUSS YOUR ANALYTICAL NEEDS<\/a><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"769\" src=\"https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/shutterstock_1026567136_chrom-1024x769.jpg\" alt=\"\" class=\"wp-image-3547\" srcset=\"https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/shutterstock_1026567136_chrom-1024x769.jpg 1024w, https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/shutterstock_1026567136_chrom-300x225.jpg 300w, https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/shutterstock_1026567136_chrom-768x577.jpg 768w, https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/shutterstock_1026567136_chrom-1536x1153.jpg 1536w, https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/shutterstock_1026567136_chrom-2048x1538.jpg 2048w, https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/shutterstock_1026567136_chrom-364x273.jpg 364w, https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/shutterstock_1026567136_chrom-500x375.jpg 500w, https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/shutterstock_1026567136_chrom-1000x751.jpg 1000w, https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/shutterstock_1026567136_chrom-1280x961.jpg 1280w, https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/shutterstock_1026567136_chrom-2000x1502.jpg 2000w, https:\/\/web.uri.edu\/pdi\/wp-content\/uploads\/sites\/1340\/shutterstock_1026567136_chrom-scaled.jpg 2560w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n<\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Analytical Development &amp; Pharmaceutical Consulting The Pharmaceutical Development Institute (PDI) provides specialized analytical development, testing, and consulting services to support pharmaceutical research and drug development. Drawing on extensive pharmaceutical industry experience in analytical development, cGMP laboratory operations, method validation, and stability programs, our scientists provide practical, scientifically rigorous solutions to complex analytical challenges.&nbsp; PDI combines [&hellip;]<\/p>\n","protected":false},"author":639,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-4211","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/pages\/4211","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/users\/639"}],"replies":[{"embeddable":true,"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/comments?post=4211"}],"version-history":[{"count":5,"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/pages\/4211\/revisions"}],"predecessor-version":[{"id":4846,"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/pages\/4211\/revisions\/4846"}],"wp:attachment":[{"href":"https:\/\/web.uri.edu\/pdi\/wp-json\/wp\/v2\/media?parent=4211"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}