{"id":20411,"date":"2023-09-19T11:55:56","date_gmt":"2023-09-19T09:55:56","guid":{"rendered":"https:\/\/ichp.lukasiewicz.gov.pl\/pharmaceutical-analysis-laboratory\/"},"modified":"2026-01-26T10:34:03","modified_gmt":"2026-01-26T09:34:03","slug":"pharmaceutical-analysis-laboratory","status":"publish","type":"page","link":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/pharmaceutical-analysis-laboratory\/","title":{"rendered":"Pharmaceutical Analysis LABORATORY"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"20411\" class=\"elementor elementor-20411 elementor-12196\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-e9912a2 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e9912a2\" data-element_type=\"section\" data-e-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-cc59ac9\" data-id=\"cc59ac9\" data-element_type=\"column\" data-e-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-3f95713 elementor-widget elementor-widget-spacer\" data-id=\"3f95713\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\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\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9b8e12d elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"9b8e12d\" 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<h3 class=\"elementor-heading-title elementor-size-default\">Pharmacy and Biotechnology Center<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-33772b2 elementor-widget elementor-widget-spacer\" data-id=\"33772b2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\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\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-268e871 elementor-widget elementor-widget-heading\" data-id=\"268e871\" 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\">Pharmaceutical Analysis LABORATORY<\/h2>\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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-72f3f9a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"72f3f9a\" data-element_type=\"section\" data-e-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-cc1e186\" data-id=\"cc1e186\" data-element_type=\"column\" data-e-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-4443c90 elementor-widget elementor-widget-spacer\" data-id=\"4443c90\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\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\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-22ad0f2 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"22ad0f2\" data-element_type=\"section\" data-e-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-50 elementor-inner-column elementor-element elementor-element-11bc10b\" data-id=\"11bc10b\" data-element_type=\"column\" data-e-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-2efb79e elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"2efb79e\" 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<h5 style=\"padding-left: 40px\"> <\/h5><h5> <\/h5><h5> <\/h5><h5> <\/h5><h5> <\/h5><h5 style=\"padding-left: 40px\"><strong>Head<\/strong><\/h5><h5 style=\"padding-left: 40px\"><strong>Aneta \u0141ukomska, PhD Sc.<\/strong><\/h5><h5 style=\"padding-left: 40px\">phone +48 453 056 148<\/h5><h5 style=\"padding-left: 40px\"><a href=\"mailto:aneta.lukomska@ichp.lukasiewicz.gov.pl\" target=\"_blank\" rel=\"noopener\">aneta.lukomska@ichp.lukasiewicz.gov.pl<\/a><\/h5>\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<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-9e86a90\" data-id=\"9e86a90\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\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-69883d9 elementor-widget elementor-widget-image\" data-id=\"69883d9\" 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\t<a href=\"https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2023\/09\/OFERTA-wspolpracy-w-dziedzinie-ANALITYKI-farmaceutycznej_IChP.jpg\" data-elementor-open-lightbox=\"yes\" data-elementor-lightbox-title=\"Adobe Photoshop PDF\" data-e-action-hash=\"#elementor-action%3Aaction%3Dlightbox%26settings%3DeyJpZCI6IjEyMzYxIiwidXJsIjoiaHR0cHM6XC9cL2ljaHAubHVrYXNpZXdpY3ouZ292LnBsXC93cC1jb250ZW50XC91cGxvYWRzXC9zaXRlc1wvMjNcLzIwMjNcLzA5XC9PRkVSVEEtd3Nwb2xwcmFjeS13LWR6aWVkemluaWUtQU5BTElUWUtJLWZhcm1hY2V1dHljem5lal9JQ2hQLmpwZyJ9\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"580\" height=\"417\" src=\"https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2023\/09\/OFERTA-wspolpracy-w-dziedzinie-ANALITYKI-farmaceutycznej_IChP-1024x737.jpg\" class=\"attachment-large size-large wp-image-12361\" alt=\"\" srcset=\"https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2023\/09\/OFERTA-wspolpracy-w-dziedzinie-ANALITYKI-farmaceutycznej_IChP-1024x737.jpg 1024w, https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2023\/09\/OFERTA-wspolpracy-w-dziedzinie-ANALITYKI-farmaceutycznej_IChP-300x216.jpg 300w, https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2023\/09\/OFERTA-wspolpracy-w-dziedzinie-ANALITYKI-farmaceutycznej_IChP-768x553.jpg 768w, https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2023\/09\/OFERTA-wspolpracy-w-dziedzinie-ANALITYKI-farmaceutycznej_IChP-1536x1106.jpg 1536w, https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2023\/09\/OFERTA-wspolpracy-w-dziedzinie-ANALITYKI-farmaceutycznej_IChP-2048x1474.jpg 2048w, https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2023\/09\/OFERTA-wspolpracy-w-dziedzinie-ANALITYKI-farmaceutycznej_IChP-1200x864.jpg 1200w, https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2023\/09\/OFERTA-wspolpracy-w-dziedzinie-ANALITYKI-farmaceutycznej_IChP-1980x1425.jpg 1980w\" sizes=\"(max-width: 580px) 100vw, 580px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\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\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-45c9ab1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"45c9ab1\" data-element_type=\"section\" data-e-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-inner-column elementor-element elementor-element-0cea0e3\" data-id=\"0cea0e3\" data-element_type=\"column\" data-e-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-ecc1923 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"ecc1923\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\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\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0024fef elementor-widget elementor-widget-toggle\" data-id=\"0024fef\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1511\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1511\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-caret-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-caret-up\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Quality Control Section<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1511\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1511\"><h6><strong>Head<\/strong><\/h6>\n<h6>Agnieszka Zieli\u0144ska, M. Sc.<\/h6>\n<h6>phone +48 601 991 900<\/h6>\n<h6><a href=\"mailto:agnieszka.zielinska@ichp.lukasiewicz.gov.pl\" target=\"_blank\" rel=\"noopener\">agnieszka.zielinska@ichp.lukasiewicz.gov.pl<\/a><\/h6>\n<\/p>\n<p><strong>The Quality Control Section carries out analyses in the field of control:<\/strong><\/p>\n<ul>\n<li>starting materials used in the manufacture of active substances and medicinal products<\/li>\n<li>intermediates manufactured in the production process (in-process testing)<\/li>\n<li>final products &#8211; active substances<\/li>\n<li>medicinal products<\/li>\n<li>packaging materials in which active substances are stored<\/li>\n<li>manufacturing conditions, including cleaning processes of process equipment<\/li>\n<\/ul>\n<p>according to Ph. Eur., USP, FP under GMP standard.<\/p>\n<p><strong>The scope of the team&#8217;s activities also includes:<\/strong><\/p>\n<ul>\n<li>stability studies (long-term, accelerated, intermediate) carried out in accordance with the principles laid down in the ICH International Guideline: &#8216;Stability&#8217; Q1A-Q1F;<\/li>\n<li>ageing tests of both active substances produced by the \u0141ukasiewicz Research Network &#8211; Industrial Chemistry Institute of Industrial and medicinal products commissioned by contractors.<\/li>\n<li>standardisation of standards for active substances and their impurities used in the various projects carried out at the Institute and offered for commercial purposes<\/li>\n<\/ul>\n<ul>\n<li>development and validation of analytical methods in accordance with current ICH requirements.<\/li>\n<li>transfer of analytical methods<\/li>\n<li>development and validation of analytical methods for cleaning process equipment used in the manufacture of active substances and medicinal products.<\/li>\n<li>determination of residual solvents in active substances by classical and Head Space methods.<\/li>\n<li>pharmaceutical availability studies (release profiles).<\/li>\n<\/ul>\n<p>On the basis of regular inspections carried out by the Main Pharmaceutical Inspectorate, the \u0141ukasiewicz Research Network &#8211; Industrial Chemistry Institute is in possession of <strong>Certificates <\/strong>which confirm compliance of production conditions of active substances with the requirements of <strong>GMP.<\/strong><\/p>\n<p>In addition, the Quality Control Section authorised by the GIF to manufacture the Medicinal Product in the scope of manufacturing operations: physicochemical tests in quality control. The team accepts analyses on request using available techniques and after signing the relevant quality agreements. <\/p>\n<p><strong>Research potential:<\/strong><\/p>\n<p>Research is carried out using high-end apparatus based on a broad spectrum of separation, isolation and identification techniques:<\/p>\n<ul>\n<li>High-performance liquid chromatography (HPLC, UPLC)<\/li>\n<li>Gas chromatography (GC-FID, GC-HS)<\/li>\n<li>Thin-layer chromatography (TLC)<\/li>\n<li>Infrared spectroscopy IR<\/li>\n<li>Spectroscopy in ultraviolet and visible light (UV-VIS)<\/li>\n<li>Instrumental and classical analysis<\/li>\n<\/ul>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1512\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-1512\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-caret-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-caret-up\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Chemical Analysis Section<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1512\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-1512\"><h6><strong>Head<\/strong><\/h6>\n<h6>Eng. Anna Chor\u0105\u017cy<\/h6>\n<h6>phone +48 668 427 668<\/h6>\n<h6><a href=\"mailto:anna.chorazy@ichp.lukasiewicz.gov.pl\" target=\"_blank\" rel=\"noopener\">anna.chorazy@ichp.lukasiewicz.gov.pl<\/a><\/h6>\n<\/p>\n<p>\u0141ukasiewicz &#8211; ICI, Pharmaceutical Analytical Laboratory, Chemical Analysis Section has again been awarded an ISO 9001 compliant <a href=\"https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2024\/02\/ISO-9001-253644-2018-AQ-POL-RvA-4-pl-PL-20240131-20240131062700.pdf\" target=\"_blank\" rel=\"noopener\"><strong><span style=\"text-decoration: underline\">Management System Certificate<\/span><\/strong><\/a> valid until 31.01.2027 as part of a recertification audit<\/p>\n<p>The Chemical Analysis Section carries out analyses of active substances, medicinal products, excipients, pharmaceutical raw materials according to Ph. Eur., USP, FP in accordance with the GMP standard.<\/p>\n<p><strong>Areas of operate<\/strong><\/p>\n<ul>\n<li>Development and optimisation of analytical methods<\/li>\n<li>Validation of analytical methods<\/li>\n<li>Validation of methods for the determination of residues of substances in the process of cleaning the production line<\/li>\n<li>Verification of analytical<\/li>\n<li>Transfer of analytical methods<\/li>\n<li>Batch certification for GMP compliance (certificate) for quality control of medicinal products, active substances and excipients and raw materials<\/li>\n<li>Pharmaceutical availability studies for various pharmaceutical forms<\/li>\n<li>Stability testing of active substances and medicinal products in qualified climate chambers under long-term conditions<\/li>\n<li>Impurity profile testing &#8211; detection, identification and quantification of impurities according to the requirements of pharmacopoeial monographs (USP, Ph. Eur., FP), recommendations of the International Conference on Pharmacopoeia (ICIP), and the International Conference on Pharmacopoeia (ICP). Harmonizacji (ICH), wymaganiami Europejskiej Agencji ds. Lek\u00f3w (EMA) oraz ameryka\u0144skiej Agencji ds. Lek\u00f3w i \u017bywno\u015bci (FDA)  <\/li>\n<li>Standardization of standards for active substances and their impurities.<\/li>\n<\/ul>\n<p><strong>Areas of operate<\/strong><\/p>\n<p>Research is carried out using high-end apparatus based on a broad spectrum of separation, isolation and identification techniques.<\/p>\n<ul>\n<li>Liquid chromatography &#8211; HPLC (UV\/PDA\/RI\/Fluorescence\/Electrochemical) on analytical, preparative and semi-preparative columns, UPLC, SEC, IEC<\/li>\n<li>Gas chromatography &#8211; GC with Headspace and FID detection<\/li>\n<li>Spectroscopy \u2013 IR, NIR, FTIR, UV-VIS<\/li>\n<li>AAS\/AES spectrometry flame and electrothermal excitation<\/li>\n<li>Analysis of particle distribution, size and shape &#8211; laser diffraction, microscopic method<\/li>\n<li>Potentiometry<\/li>\n<li>Classical methods: weight analysis, titration analysis<\/li>\n<\/ul>\n<p>For many years, the Chemical Analysis Section has been cooperating with pharmaceutical companies and research centres in Poland and abroad in the field of quality control of medicinal products and raw materials, development studies, expert opinions and consultancy in the drug registration process.<\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1513\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-1513\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-caret-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-caret-up\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Research Analytical Section<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1513\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-1513\"><h6><strong>Head<\/strong><\/h6>\n<h6>PhD. Sc. Eng. Marta Zezula<\/h6>\n<h6>phone +48 601 333 919<\/h6>\n<h6><a href=\"mailto:marta.zezula@ichp.lukasiewicz.gov.pl\" target=\"_blank\" rel=\"noopener\">marta.zezula@ichp.lukasiewicz.gov.pl<\/a><\/h6>\n<\/p>\n<p>In the Research Analytics Section, research work is carried out on the full analytical characterisation of chemicals and pharmaceuticals, as well as analytical work for various pharmaceutical forms (tablets, capsules, solutions, eye drops in solution and suspension form, emulsions and ointments). On the basis of the research conducted, documentation is prepared that meets the requirements of the committees creating quality criteria for medicines, including the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the European and US registration authorities.<\/p>\n<p>The Research Analytics team cooperates with scientific and industrial units by carrying out analytical work as part of scientific projects. The results of research work are presented in national and international journals and at scientific conferences. <\/p>\n<p><strong>Areas of operate<\/strong><\/p>\n<p><strong>Expertise, method development and validation in:<\/strong><\/p>\n<ul>\n<li>determination of chemical and enantiomeric purity and content of chemical and pharmaceutical substances (HPLC, UHPLC with UV\/VIS detection, PDA, Corona CAD, MS)<\/li>\n<li>determination of complete contaminant profiles, including genotoxic ones<\/li>\n<li>determination of release profiles for the active substance(s) in drug form (HPLC, UHPLC with UV\/VIS detection, PDA)<\/li>\n<li>studies on the compatibility of the active substance with excipients at the development stage<\/li>\n<li>determination of residual solvent content (GC-FID, GC-HS, GC-MS)<\/li>\n<li>determination of substance content by potentiometric titrations<\/li>\n<li>determination of trace elements (ICP-MS)<\/li>\n<li>determination of water content using the volumetric and coulometric Karl Fischer methods,<\/li>\n<li>chemical structure determination (NMR, IR and Raman spectroscopies, X-ray mono-crystalline and powder diffraction)<\/li>\n<li>qualitative and quantitative analyses of phase transformations in solids, including polymorphic transformations (e.g. quantitative analysis using the Rietveld method) and calculation of the degree of crystallinity<\/li>\n<li>determination of particle size and shape distribution profiles<\/li>\n<li>determination of solubility and determination of pKa (UV-Vis)<\/li>\n<li>stability studies under accelerated and long-term conditions.<\/li>\n<\/ul>\n<p><strong>Polymorphism studies<\/strong><\/p>\n<ul>\n<li>X-ray powder diffraction (XRPD)<\/li>\n<li>X-ray monocrystalline diffraction<\/li>\n<li>differential scanning calorimetry (DSC)<\/li>\n<li>infrared spectroscopy (FTIR\/ATR)<\/li>\n<li>Raman spectroscopy<\/li>\n<\/ul>\n<p><strong>Preformulation studies<\/strong><\/p>\n<ul>\n<li>laser diffraction<\/li>\n<li>automated microscopic analysis<\/li>\n<li>PH solubility test of active substances. Eu. <\/li>\n<\/ul>\n<p><strong>GMP analyses<\/strong><\/p>\n<ul>\n<li>X-ray powder diffraction (XRPD)<\/li>\n<li>gas chromatography with mass spectrometry detection (GC-MS)<\/li>\n<li>nuclear magnetic resonance (NMR 500 MHz)<\/li>\n<li>trace element analysis (ICP-MS)<\/li>\n<\/ul>\n<p><strong>Drug form analysis<\/strong><\/p>\n<ul>\n<li>preformulation testing: solubility testing and release profiles<\/li>\n<li>physico-chemical tests and pharmaceutical availability tests for different pharmaceutical forms<\/li>\n<li>analysis of food supplements (identity, content, heavy metals)<\/li>\n<li>analysis of natural products (identity, content and release) and veterinary products (identity, content, release and chemical purity).<\/li>\n<\/ul>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1514\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-1514\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-caret-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-caret-up\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Pharmacokinetics Section<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1514\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-1514\"><h6><strong>Head<\/strong><\/h6>\n<h6>Edyta Pesta, M. Sc.<\/h6>\n<h6>phone +48 453 056 167<\/h6>\n<h6><a href=\"mailto:edyta.pesta@ichp.lukasiewicz.gov.pl\" target=\"_blank\" rel=\"noopener\">edyta.pesta@ichp.lukasiewicz.gov.pl<\/a><\/h6>\n<\/p>\n<p>Zesp\u00f3\u0142 Farmakokinetyki prowadzi prace w zakresie bada\u0144 bior\u00f3wnowa\u017cno\u015bci (od 1993 r.) i dost\u0119pno\u015bci biologicznej produkt\u00f3w leczniczych. Since 2003, the team has been working according to the principles of Good Laboratory Practice (Certificate No. 25\/2020\/DPL). The team has performed more than 400 validations of analytical methods and pharmacokinetic studies in collaboration with national and international pharmaceutical companies and clinical centres.<\/p>\n<p><strong>Areas of operate<\/strong><\/p>\n<ul>\n<li>Study design preparation<\/li>\n<li>Development or adaptation of a bioanalytical method for the determination of a medicinal substance and\/or metabolites in biological material<\/li>\n<li>Validation of the bioanalytical method in accordance with EMA requirements<\/li>\n<li>Performance of assays in a biological material (HPLC, LC\/MS\/MS)<\/li>\n<li>Pharmacokinetic calculations (WinNonlin)<\/li>\n<li>Study documentation in CTD format Module 5:<\/li>\n<li>Archiving of biological material samples (\u2264-14\u00b0C and \u2264 -60\u00b0C)<\/li>\n<li>Preparation of expert opinions<\/li>\n<li>Management of pharmacokinetic studies (including clinical part)<\/li>\n<li>Preparation of application for funding<\/li>\n<\/ul>\n<p><strong>Research equipment and capacity:<\/strong><\/p>\n<ul>\n<li>Quattro PREMIER tandem mass spectrometer (Waters) coupled to HPLC (LC\/MS\/MS)<\/li>\n<li>LCMS-2010 mass spectrometer (Shimadzu) coupled to HPLC (LC\/MS)<\/li>\n<li>UHPLC and HPLC with UV-VIS, electrochemical and fluorimetric detectors<\/li>\n<li>XEVO TQ-XS mass spectrometer connected to Acquity Class I UPLC<\/li>\n<li>SOLO Version 8.37 sample preparation machine for analysis, from Hudson Robotics, Inc.<\/li>\n<li>Free online tool for the presentation of Incurred sample reanalysis (ISR) results prepared in collaboration with the Warsaw University of Technology, available at <a href=\"https:\/\/modelvis.shinyapps.io\/isrVis\/\">https:\/\/modelvis.shinyapps.io\/isrVis\/<\/a>. The tool was presented in the journal <a href=\"https:\/\/www.future-science.com\/doi\/full\/10.4155\/bio-2017-0038\" target=\"_blank\" rel=\"noopener noreferrer\">Bioanalysis, Vol.9, No.12<\/a>. <\/li>\n<li>A free online tool to help find the cause of ISR results not meeting acceptance criteria, prepared in collaboration with the Warsaw University of Technology: <a href=\"https:\/\/modelvis.shinyapps.io\/isr3d\/\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/modelvis.shinyapps.io\/isr3d\/<\/a> . The tool was presented in the journal <a href=\"https:\/\/www.future-science.com\/doi\/full\/10.4155\/bio-2017-0038\" target=\"_blank\" rel=\"noopener noreferrer\">Bioanalysis, Vol.10, No.3<\/a> <\/li>\n<\/ul>\n<p><strong><a href=\"https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2024\/02\/certyfikat-GLP-6_2022.pdf\" target=\"_blank\" rel=\"noopener\">GOOD LABORATORY PRACTICE CERTIFICATE<\/a> <\/strong><\/p>\n<p><strong>(<a href=\"https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2024\/02\/Certyfikat-GLP-6_2022-ang.pdf\" target=\"_blank\" rel=\"noopener\">GOOD LABORATORY PRACTICE CERTIFICATE<\/a>)<\/strong><\/p>\n<h6><a href=\"https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2024\/02\/Portfolio-Sekcja-Farmakokinetyki.pdf\" target=\"_blank\" rel=\"noopener\"><strong>List of bioanalytical methods in GLP system<\/strong><\/a><\/h6>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1515\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-1515\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-caret-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-caret-up\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Microbiological Analysis Section<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1515\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-1515\"><h6><strong>Head<\/strong><\/h6>\n<h6>Bogna Pi\u0105tkowska, M. Sc.<\/h6>\n<h6>phone +48 507 333 379<\/h6>\n<h6><a href=\"mailto:bogna.piatkowska@ichp.lukasiewicz.gov.pl\" target=\"_blank\" rel=\"noopener\">bogna.piatkowska@ichp.lukasiewicz.gov.pl<\/a><\/h6>\n<\/p>\n<p>The Microbiological Analysis Section carries out microbiological testing work for industrial clients and as part of \u0141ukasiewicz- ICHP&#8217;s internal co-operation. The Microbiological Analysis Section is GMP-certified and is regularly audited by contract research companies and the General Pharmaceutical Inspectorate. In addition to standard tests in quality control, the team also develops test methods for specific pharmaceutical and non-drug products.  <\/p>\n<p><strong>Areas of operate<\/strong><\/p>\n<ul>\n<li>sterility testing<\/li>\n<li>microbiological purity testing<\/li>\n<li>testing of bacterial endotoxins (gel method: limit test)<\/li>\n<li>antimicrobial efficacy testing<\/li>\n<li>effectiveness of disinfectants<\/li>\n<li>microbiological monitoring of clean rooms<\/li>\n<li>testing of the fertility and sterility of microbiological media<\/li>\n<li>validation and transfer of microbiological methods &#8211; confirmation of the suitability of a method for a given application.<\/li>\n<\/ul>\n<p><strong> Research potential:<\/strong><\/p>\n<ul>\n<li>premises of appropriate cleanliness classes, including Class B, <\/li>\n<li>cabinets with laminar air flow,<\/li>\n<li>heaters, autoclave, steriliser, water bath, analytical balances, steritest and other necessary equipment for analyses<\/li>\n<\/ul>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1516\" class=\"elementor-tab-title\" data-tab=\"6\" role=\"button\" aria-controls=\"elementor-tab-content-1516\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><i class=\"fas fa-caret-right\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><i class=\"elementor-toggle-icon-opened fas fa-caret-up\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">ISO-9001 CERTIFICATE<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1516\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"region\" aria-labelledby=\"elementor-tab-title-1516\"><p><a href=\"https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2024\/02\/ISO-9001-253644-2018-AQ-POL-RvA-4-pl-PL-20240131-20240131062700.pdf\">ISO-9001-253644-2018-AQ-POL-RvA-4-en-PL-20240131-20240131062700<\/a> \u0141ukasiewicz Research Network &#8211; ICI, Pharmaceutical Analytical Laboratory, Chemical Analysis Section has again received an <a href=\"https:\/\/ichp.lukasiewicz.gov.pl\/wp-content\/uploads\/sites\/23\/2024\/02\/ISO-9001-253644-2018-AQ-POL-RvA-4-pl-PL-20240131-20240131062700.pdf\" target=\"_blank\" rel=\"noopener\"><strong><span style=\"text-decoration: underline\">ISO 9001 compliant Management System Certificate <\/span><\/strong><\/a>valid until 31.01.2027\/ as part of a recertification audit.<\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\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\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7000f21 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"7000f21\" data-element_type=\"section\" data-e-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-734b293\" data-id=\"734b293\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\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>Pharmacy and Biotechnology Center Pharmaceutical Analysis LABORATORY Head Aneta \u0141ukomska, PhD Sc. phone +48 453 056 148 aneta.lukomska@ichp.lukasiewicz.gov.pl Quality Control Section Head Agnieszka Zieli\u0144ska, M. Sc. phone +48 601 991 900 agnieszka.zielinska@ichp.lukasiewicz.gov.pl The Quality Control Section carries out analyses in the field of control: starting materials used in the manufacture of active substances and medicinal [&hellip;]<\/p>\n","protected":false},"author":125,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_seopress_robots_primary_cat":"","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","inline_featured_image":false,"footnotes":""},"class_list":["post-20411","page","type-page","status-publish","hentry"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-02-15 20:12:10","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"translation_priority","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/wp-json\/wp\/v2\/pages\/20411","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/wp-json\/wp\/v2\/users\/125"}],"replies":[{"embeddable":true,"href":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/wp-json\/wp\/v2\/comments?post=20411"}],"version-history":[{"count":5,"href":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/wp-json\/wp\/v2\/pages\/20411\/revisions"}],"predecessor-version":[{"id":29669,"href":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/wp-json\/wp\/v2\/pages\/20411\/revisions\/29669"}],"wp:attachment":[{"href":"https:\/\/ichp.lukasiewicz.gov.pl\/en\/wp-json\/wp\/v2\/media?parent=20411"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}