{"id":16,"date":"2020-02-03T13:29:14","date_gmt":"2020-02-03T13:29:14","guid":{"rendered":"https:\/\/www.almacgroup.com\/analytical-solid-state\/?page_id=16"},"modified":"2025-09-30T14:35:36","modified_gmt":"2025-09-30T13:35:36","slug":"analytical-method-development-and-validation","status":"publish","type":"page","link":"https:\/\/almacgroup.jp\/analytical-solid-state\/analytical-method-development-and-validation\/","title":{"rendered":"\u30e1\u30bd\u30c3\u30c9\u958b\u767a\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3"},"content":{"rendered":"\n<h3 class=\"wp-block-heading\" id=\"h-\u6bce\u5e74300\u3092\u8d85\u3048\u308b\u539f\u85ac\u3068\u88fd\u5264\u6cd5\u306e\u958b\u767a\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\">\u6bce\u5e74300\u3092\u8d85\u3048\u308b\u539f\u85ac\u3068\u88fd\u5264\u6cd5\u306e\u958b\u767a\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3<\/h3>\n\n\n\n<p>\u5206\u6790\u6cd5\u306e\u958b\u767a\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306f\u3001\u305d\u306e\u65b9\u6cd5\u304c\u5341\u5206\u306b\u5b9a\u7fa9\u3055\u308c\u3001\u76ee\u7684\u306b\u9069\u5408\u3057\u3001\u5f97\u3089\u308c\u305f\u7d50\u679c\u304c\u5805\u7262\u304b\u3064\u4fe1\u983c\u6027\u304c\u9ad8\u304f\u3001\u6b21\u306e\u958b\u767a\u30de\u30a4\u30eb\u30b9\u30c8\u30fc\u30f3\u306b\u9032\u3080\u305f\u3081\u306e\u696d\u754c\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5f93\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u3001\u533b\u85ac\u54c1\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u306b\u306f\u4e0d\u53ef\u6b20\u3067\u3059\u3002<\/p>\n\n\n\n<p>Almac\u306b\u306f\u8c4a\u5bcc\u306a\u7d4c\u9a13\u304c\u3042\u308a\u3001\u5148\u9032\u7684\u306a\u6a5f\u5668\u3068\u3068\u3082\u306b\u3001\u52b9\u7387\u7684\u304b\u3064\u6b63\u78ba\u3001\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u5805\u7262\u306a\u5206\u6790\u30e1\u30bd\u30c3\u30c9\u306e\u958b\u767a\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u304c\u53ef\u80fd\u3067\u3059\u3002<\/p>\n\n\n\n<p><strong>\u30e1\u30bd\u30c3\u30c9\u958b\u767a &nbsp; &nbsp;<\/strong><\/p>\n\n\n\n<p>\u5f53\u793e\u306e\u719f\u7df4\u3057\u305f\u30e1\u30bd\u30c3\u30c9\u958b\u767a\u306b\u643a\u308f\u308b\u79d1\u5b66\u8005\u306f\u3001\u3055\u307e\u3056\u307e\u306a\u7a2e\u985e\u306e\u88fd\u54c1\u3001\u5206\u6790\u6cd5\u3001\u5206\u6790\u6280\u8853\u3067\u696d\u52d9\u3092\u884c\u3044\u3001\u9577\u5e74\u306b\u308f\u305f\u3063\u3066\u7d4c\u9a13\u3092\u7a4d\u307f\u3001\u6210\u529f\u3092\u7bc9\u3044\u3066\u304d\u307e\u3057\u305f\u3002\u9ad8\u5ea6\u306a\u5206\u6790\u6a5f\u5668\u3092\u5099\u3048\u305f\u30e9\u30dc\u3092\u5229\u7528\u3057\u3001\u304a\u5ba2\u69d8\u306e\u3042\u3089\u3086\u308b\u30cb\u30fc\u30ba\u306b\u5408\u3046\u5206\u6790\u30e1\u30bd\u30c3\u30c9\u306e\u958b\u767a\u304c\u53ef\u80fd\u3067\u3059\u3002<\/p>\n\n\n\n<p><strong>\u30e1\u30bd\u30c3\u30c9\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3<\/strong><\/p>\n\n\n\n<p>Almac\u306e\u5206\u6790\u30c1\u30fc\u30e0\u306f\u3001\u81e8\u5e8a\u958b\u767a\u306e\u69d8\u3005\u306a\u6bb5\u968e\u306b\u5408\u308f\u305b\u305f\u30e1\u30bd\u30c3\u30c9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u5fc5\u8981\u6027\u3092\u719f\u77e5\u3057\u3066\u3044\u307e\u3059\u3002\u30e1\u30bd\u30c3\u30c9\u304c\u898f\u5236\u8981\u4ef6\u3092\u78ba\u5b9f\u306b\u6e80\u305f\u3059\u3088\u3046\u3001\u304a\u5ba2\u69d8\u56fa\u6709\u306e\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8\u3068\u4f75\u305b\u3066\u3001ICH Q2\uff08R1\uff09\u3084\u516c\u5b9a\u66f8\u30ac\u30a4\u30c0\u30f3\u30b9\u306a\u3069\u3001\u95a2\u9023\u3059\u308bICH\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u9075\u5b88\u3057\u307e\u3059\u3002\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u5b8c\u4e86\u6642\u306b\u306f\u5305\u62ec\u7684\u306a\u5831\u544a\u66f8\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002<\/p>\n\n\n\t<article class=\"o-grid o-grid--full\">\n\n\t\t<div class=\"o-grid__item u-width-full u-m-t6 u-m-t4@m u-m-b4\">\n\t\t\t<h2 class=\"u-normal u-a-center\">\u95a2\u9023\u30ea\u30bd\u30fc\u30b9<\/h2>\n\t\t<\/div>\n\n\t\t<div class=\"u-flex u-flex-justify-center u-flex-wrap u-width-full c-news-panels__slider js-news-panels\">\n\t\t\t\t\t\t\t<article class=\"u-width-1\/4 u-width-half@l u-width-full@m\">\n\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2024\/09\/Almac_Analytical_Equipment_List.pdf\">\n\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"c-news-panels u-a-center\">\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__img\" style=\"background-image: url('https:\/\/almacgroup.jp\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2021\/03\/4.jpeg');\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-meta\">\u5206\u6790\u6a5f\u5668\u30ea\u30b9\u30c8<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__content u-width-full u-p-x2 u-p-y2 u-bg-white\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-18 u-normal\">\u5206\u6790\u6a5f\u5668\u30ea\u30b9\u30c8<\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t\t\t<article class=\"u-width-1\/4 u-width-half@l u-width-full@m\">\n\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/outsourcing-analytical-services-because-its-worth-it\/\">\n\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"c-news-panels u-a-center\">\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__img\" style=\"background-image: url('https:\/\/almacgroup.jp\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2021\/08\/SI-KC-image-1.png');\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-meta\">\u8ad6\u6587<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__content u-width-full u-p-x2 u-p-y2 u-bg-white\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-18 u-normal\">\u5206\u6790\u30b5\u30fc\u30d3\u30b9\u306e\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0&#8230;\u305d\u308c\u3060\u3051\u306e\u4fa1\u5024\u304c\u3042\u308b<\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t\t\t<article class=\"u-width-1\/4 u-width-half@l u-width-full@m\">\n\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/analytical-method-development-for-synthetic-peptide-for-purity-and-impurities-content-by-uhplc\/\">\n\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"c-news-panels u-a-center\">\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__img\" style=\"background-image: url('https:\/\/almacgroup.jp\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2023\/09\/Peptides.png');\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-meta\">\u30b1\u30fc\u30b9\u30b9\u30bf\u30c7\u30a3<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__content u-width-full u-p-x2 u-p-y2 u-bg-white\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-18 u-normal\">UHPLC\u306b\u3088\u308b\u5408\u6210\u30da\u30d7\u30c1\u30c9\u304a\u3088\u3073\u7d14\u5ea6\u3084\u4e0d\u7d14\u7269\u542b\u91cf\u306e\u5206\u6790\u6cd5\u306e\u958b\u767a<\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t<\/div>\n\t<\/article>\n\n\n<!-- <article id=\"related\">\n\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full u-a-center\">\n\t\t\t\t\t\t\t<h3 class=\"u-normal u-m-b4\">\u95a2\u9023\u30ea\u30bd\u30fc\u30b9<\/h3>\n\t\t\t\t\t<\/div>\n\t\n\t\t<div class=\"u-flex u-flex-justify-center u-flex-wrap u-width-full c-resources__slider js-resources-panels\">\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t<article class=\"c-resources__grid u-width-4\/12 u-width-half@l u-width-full@m\">\n\t\t\t\t\n\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2024\/09\/Almac_Analytical_Equipment_List.pdf\" target=\"\">\n\t\t\t\t\t\t<div class=\"c-resources c-overlay__ u-a-center\" style=\"background-image: url('https:\/\/almacgroup.jp\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2021\/03\/4.jpeg');\">\n\t\t\t\t\t\t\t<div class=\"c-resources__gradient-inner\">\n\t\t\t\t\t\t\t\t<p class=\"c-resources__type u-text-small u-bold u-m-b1\">\u5206\u6790\u6a5f\u5668\u30ea\u30b9\u30c8<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"u-normal\">\u5206\u6790\u6a5f\u5668\u30ea\u30b9\u30c8<\/h3>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\n\t\t\t\t\t\t\t\t\t<article class=\"c-resources__grid u-width-4\/12 u-width-half@l u-width-full@m\">\n\t\t\t\t\n\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/outsourcing-analytical-services-because-its-worth-it\/\" target=\"\">\n\t\t\t\t\t\t<div class=\"c-resources c-overlay__ u-a-center\" style=\"background-image: url('https:\/\/almacgroup.jp\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2021\/08\/SI-KC-image-1.png');\">\n\t\t\t\t\t\t\t<div class=\"c-resources__gradient-inner\">\n\t\t\t\t\t\t\t\t<p class=\"c-resources__type u-text-small u-bold u-m-b1\">\u8ad6\u6587<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"u-normal\">\u5206\u6790\u30b5\u30fc\u30d3\u30b9\u306e\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0...\u305d\u308c\u3060\u3051\u306e\u4fa1\u5024\u304c\u3042\u308b<\/h3>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\n\t\t\t\t\t\t\t\t\t<article class=\"c-resources__grid u-width-4\/12 u-width-half@l u-width-full@m\">\n\t\t\t\t\n\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/analytical-method-development-for-synthetic-peptide-for-purity-and-impurities-content-by-uhplc\/\" target=\"\">\n\t\t\t\t\t\t<div class=\"c-resources c-overlay__ u-a-center\" style=\"background-image: url('https:\/\/almacgroup.jp\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2023\/09\/Peptides.png');\">\n\t\t\t\t\t\t\t<div class=\"c-resources__gradient-inner\">\n\t\t\t\t\t\t\t\t<p class=\"c-resources__type u-text-small u-bold u-m-b1\">\u30b1\u30fc\u30b9\u30b9\u30bf\u30c7\u30a3<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"u-normal\">UHPLC\u306b\u3088\u308b\u5408\u6210\u30da\u30d7\u30c1\u30c9\u304a\u3088\u3073\u7d14\u5ea6\u3084\u4e0d\u7d14\u7269\u542b\u91cf\u306e\u5206\u6790\u6cd5\u306e\u958b\u767a<\/h3>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t<\/div>\n\t<\/div>\n<\/article> -->\n","protected":false},"excerpt":{"rendered":"<p>\u6bce\u5e74300\u3092\u8d85\u3048\u308b\u539f\u85ac\u3068\u88fd\u5264\u6cd5\u306e\u958b\u767a\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3 \u5206\u6790\u6cd5\u306e\u958b\u767a\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306f\u3001\u305d\u306e\u65b9\u6cd5\u304c\u5341\u5206\u306b\u5b9a\u7fa9\u3055\u308c\u3001\u76ee\u7684\u306b\u9069\u5408\u3057\u3001\u5f97\u3089\u308c\u305f\u7d50\u679c\u304c\u5805\u7262\u304b\u3064\u4fe1\u983c\u6027\u304c\u9ad8\u304f\u3001\u6b21\u306e\u958b\u767a\u30de\u30a4\u30eb\u30b9\u30c8\u30fc\u30f3\u306b\u9032\u3080\u305f\u3081\u306e\u696d\u754c\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5f93\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u3001\u533b\u85ac\u54c1\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u306b\u306f\u4e0d\u53ef\u6b20\u3067\u3059\u3002 Almac\u306b\u306f\u8c4a\u5bcc\u306a\u7d4c\u9a13\u304c\u3042\u308a\u3001\u5148\u9032\u7684\u306a\u6a5f\u5668\u3068\u3068\u3082\u306b\u3001\u52b9\u7387\u7684\u304b\u3064\u6b63\u78ba\u3001\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u5805\u7262\u306a\u5206\u6790\u30e1\u30bd\u30c3\u30c9\u306e\u958b\u767a\u3068\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u304c\u53ef\u80fd\u3067\u3059\u3002 \u30e1\u30bd\u30c3\u30c9\u958b\u767a &nbsp; &nbsp; 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