{"id":543,"date":"2026-08-27T18:00:00","date_gmt":"2026-08-27T18:00:00","guid":{"rendered":"https:\/\/nhdbio.com\/?p=543"},"modified":"2026-08-28T08:41:50","modified_gmt":"2026-08-28T08:41:50","slug":"lc-ms-peptide-identity-exact-mass-isotopes-msms","status":"publish","type":"post","link":"https:\/\/nhdbio.com\/ja\/lc-ms-peptide-identity-exact-mass-isotopes-msms\/","title":{"rendered":"LC-MS \u30da\u30d7\u30c1\u30c9\u306e\u30a2\u30a4\u30c7\u30f3\u30c6\u30a3\u30c6\u30a3\u306e\u8aad\u307f\u53d6\u308a: \u6b63\u78ba\u306a\u8cea\u91cf\u3001\u540c\u4f4d\u4f53\u30a8\u30f3\u30d9\u30ed\u30fc\u30d7\u3001\u304a\u3088\u3073 MS\/MS"},"content":{"rendered":"

\u8cea\u91cf\u5206\u6790\u306f\u30da\u30d7\u30c1\u30c9\u306e\u540c\u4e00\u6027\u306b\u95a2\u3059\u308b\u5f37\u529b\u306a\u8a3c\u62e0\u3092\u63d0\u4f9b\u3057\u307e\u3059\u304c\u3001\u300c\u8cea\u91cf\u304c\u4e00\u81f4\u3059\u308b\u300d\u3068\u3044\u3046\u6587\u306f\u4e0d\u5b8c\u5168\u3067\u3059\u3002\u6709\u7528\u306a\u89e3\u91c8\u3068\u3057\u3066\u306f\u3001\u3069\u306e\u30a4\u30aa\u30f3\u304c\u6e2c\u5b9a\u3055\u308c\u305f\u304b\u3001\u96fb\u8377\u72b6\u614b\u304c\u3069\u306e\u3088\u3046\u306b\u5272\u308a\u5f53\u3066\u3089\u308c\u305f\u304b\u3001\u4e2d\u6027\u8cea\u91cf\u304c\u6b63\u3057\u304f\u30c7\u30b3\u30f3\u30dc\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3055\u308c\u305f\u304b\u3069\u3046\u304b\u3001\u3069\u306e\u3088\u3046\u306a\u8cea\u91cf\u8a31\u5bb9\u8aa4\u5dee\u304c\u4f7f\u7528\u3055\u308c\u305f\u304b\u3001\u304a\u3088\u3073\u30d5\u30e9\u30b0\u30e1\u30f3\u30c8\u306e\u8a3c\u62e0\u304c\u63d0\u6848\u3055\u308c\u305f\u30b7\u30fc\u30b1\u30f3\u30b9\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u304c\u554f\u308f\u308c\u307e\u3059\u3002<\/p>\n

ICH Q6B<\/a> \u306f\u3001\u76f8\u88dc\u7684\u306a\u7279\u6027\u8a55\u4fa1\u30c4\u30fc\u30eb\u3068\u3057\u3066\u306e\u8cea\u91cf\u5206\u6790\u6cd5\u3068\u30da\u30d7\u30c1\u30c9\u30de\u30c3\u30d4\u30f3\u30b0\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002 FDA \u306e\u5408\u6210\u30da\u30d7\u30c1\u30c9\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306f\u3001\u30da\u30d7\u30c1\u30c9\u95a2\u9023\u306e\u4e0d\u7d14\u7269\u306e\u7ba1\u7406\u306b\u3082\u91cd\u70b9\u3092\u7f6e\u3044\u3066\u3044\u307e\u3059\u3002\u5b9f\u969b\u306e\u6559\u8a13\u306f\u3001\u5358\u4e00\u306e\u4e38\u3081\u3089\u308c\u305f\u5206\u5b50\u91cf\u5024\u304c\u8a3c\u660e\u66f8\u306b\u30b3\u30d4\u30fc\u3055\u308c\u308b\u5834\u5408\u3067\u306f\u306a\u304f\u3001\u76f4\u4ea4\u3059\u308b\u89b3\u5bdf\u304c\u53ce\u675f\u3059\u308b\u5834\u5408\u306b\u540c\u4e00\u6027\u304c\u3088\u308a\u5f37\u529b\u306b\u306a\u308b\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002<\/p>\n

\u30da\u30d7\u30c1\u30c9\u304c\u8907\u6570\u306e m\/z \u5024\u3067\u73fe\u308c\u308b\u7406\u7531<\/h2>\n

\u30a8\u30ec\u30af\u30c8\u30ed\u30b9\u30d7\u30ec\u30fc \u30a4\u30aa\u30f3\u5316\u3067\u306f\u901a\u5e38\u3001\u8907\u6570\u306e\u96fb\u8377\u72b6\u614b\u304c\u751f\u6210\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u6a5f\u5668\u306f\u3001\u4e2d\u6027\u5206\u5b50\u91cf\u3092\u76f4\u63a5\u6e2c\u5b9a\u3059\u308b\u306e\u3067\u306f\u306a\u304f\u3001m\/z \u3067\u66f8\u304b\u308c\u305f\u8cea\u91cf\u96fb\u8377\u6bd4\u3092\u6e2c\u5b9a\u3057\u307e\u3059\u3002 3 \u3064\u306e\u30d7\u30ed\u30c8\u30f3\u3092\u6301\u3064\u30da\u30d7\u30c1\u30c9\u306f\u30014 \u3064\u306e\u30d7\u30ed\u30c8\u30f3\u3092\u6301\u3064\u540c\u3058\u5206\u5b50\u3068\u306f\u7570\u306a\u308b m\/z \u3067\u73fe\u308c\u307e\u3059\u3002\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306f\u96fb\u8377\u72b6\u614b\u30a8\u30f3\u30d9\u30ed\u30fc\u30d7\u3092\u30c7\u30b3\u30f3\u30dc\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3055\u308c\u305f\u8cea\u91cf\u306b\u7d50\u5408\u3067\u304d\u307e\u3059\u304c\u3001\u57fa\u790e\u3068\u306a\u308b\u30b9\u30da\u30af\u30c8\u30eb\u3068\u96fb\u8377\u306e\u5272\u308a\u5f53\u3066\u306f\u30ec\u30d3\u30e5\u30fc\u53ef\u80fd\u306a\u307e\u307e\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n

\u4ed8\u52a0\u7269\u3001\u5bfe\u30a4\u30aa\u30f3\u3001\u9178\u5316\u3001\u8131\u6c34\u3001\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u4fee\u98fe\u306b\u3088\u308a\u3001\u89b3\u5bdf\u3055\u308c\u308b\u30a4\u30aa\u30f3\u304c\u5909\u5316\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u4e88\u60f3\u3055\u308c\u308b\u30a4\u30aa\u30f3\u306e\u5f0f\u3092\u8a18\u8f09\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059: \u5e73\u5747\u8cea\u91cf\u307e\u305f\u306f\u5358\u540c\u4f4d\u4f53\u8cea\u91cf\u3001\u4e2d\u6027\u5206\u5b50\u307e\u305f\u306f\u30d7\u30ed\u30c8\u30f3\u5316\u30a4\u30aa\u30f3\u3001\u304a\u3088\u3073\u672b\u7aef\u4fee\u98fe\u304c\u542b\u307e\u308c\u308b\u304b\u3069\u3046\u304b\u3002<\/p>\n

\u6b63\u78ba\u306a\u8cea\u91cf\u306f\u53ef\u80fd\u6027\u3092\u72ed\u3081\u307e\u3059\u3002\u305d\u308c\u306f\u9806\u5e8f\u3092\u8a3c\u660e\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093<\/h2>\n

\u9ad8\u89e3\u50cf\u5ea6\u306e\u7121\u50b7\u8cea\u91cf\u4e00\u81f4\u306b\u3088\u308a\u3001\u591a\u304f\u306e\u9593\u9055\u3063\u305f\u7d44\u6210\u3092\u6392\u9664\u3067\u304d\u307e\u3059\u3002\u30ed\u30a4\u30b7\u30f3\u3068\u30a4\u30bd\u30ed\u30a4\u30b7\u30f3\u3001\u4f4d\u7f6e\u7570\u6027\u4f53\u3001\u307e\u305f\u306f\u540c\u3058\u5143\u7d20\u7d44\u6210\u3092\u6301\u3064 2 \u3064\u306e\u914d\u5217\u3092\u5fc5\u305a\u3057\u3082\u533a\u5225\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002\u30b7\u30fc\u30b1\u30f3\u30b9\u306e\u9806\u5217\u306f\u3001\u5b8c\u5168\u306a\u8cea\u91cf\u3092\u5171\u6709\u3067\u304d\u307e\u3059\u3002\u3053\u306e\u305f\u3081\u3001\u8cea\u91cf\u4e00\u81f4\u306f\u540c\u4e00\u6027\u3092\u88cf\u4ed8\u3051\u307e\u3059\u304c\u3001\u305d\u308c\u81ea\u4f53\u3092\u5b8c\u5168\u306a\u914d\u5217\u78ba\u8a8d\u3068\u3057\u3066\u8aac\u660e\u3059\u3079\u304d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n

\n\n\n\n\n\n\n\n\n\n
\u8a3c\u62e0\u5c64<\/th>\n\u5f79\u7acb\u3064\u8cea\u554f<\/th>\n\u91cd\u8981\u306a\u5236\u9650\u4e8b\u9805<\/th>\n<\/tr>\n<\/thead>\n
\u7121\u50b7\u306e m\/z \u30a8\u30f3\u30d9\u30ed\u30fc\u30d7<\/td>\n\u30b3\u30d2\u30fc\u30ec\u30f3\u30c8\u306a\u96fb\u8377\u72b6\u614b\u306f\u5b58\u5728\u3057\u307e\u3059\u304b?<\/td>\n\u4ed8\u52a0\u7269\u3084\u91cd\u8907\u3059\u308b\u7a2e\u306f\u5272\u308a\u5f53\u3066\u3092\u8907\u96d1\u306b\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059<\/td>\n<\/tr>\n
\u30c7\u30b3\u30f3\u30dc\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3055\u308c\u305f\u8cea\u91cf<\/td>\n\u89b3\u6e2c\u3055\u308c\u305f\u4e2d\u6027\u8cea\u91cf\u306f\u898f\u5b9a\u306e\u8a31\u5bb9\u7bc4\u56f2\u5185\u3067\u4e00\u81f4\u3057\u307e\u3059\u304b?<\/td>\n\u540c\u91cd\u4f53\u69cb\u9020\u307e\u305f\u306f\u7570\u6027\u4f53\u69cb\u9020\u304c\u6b8b\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b<\/td>\n<\/tr>\n
\u540c\u4f4d\u4f53\u30a8\u30f3\u30d9\u30ed\u30fc\u30d7<\/td>\n\u5fae\u7d30\u69cb\u9020\u306f\u63d0\u6848\u3055\u308c\u305f\u7d44\u6210\u306b\u9069\u5408\u3057\u307e\u3059\u304b?<\/td>\n\u89e3\u50cf\u5ea6\u3068\u4fe1\u53f7\u54c1\u8cea\u306b\u3088\u3063\u3066\u8b58\u5225\u529b\u304c\u6c7a\u307e\u308a\u307e\u3059<\/td>\n<\/tr>\n
MS\/MS \u30d5\u30e9\u30b0\u30e1\u30f3\u30c8<\/td>\nb\/y \u307e\u305f\u306f\u4ed6\u306e\u30d5\u30e9\u30b0\u30e1\u30f3\u30c8 \u30b7\u30ea\u30fc\u30ba\u306f\u30b7\u30fc\u30b1\u30f3\u30b9\u9818\u57df\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3066\u3044\u307e\u3059\u304b?<\/td>\n\u30ab\u30d0\u30ec\u30c3\u30b8\u30ae\u30e3\u30c3\u30d7\u3084\u66d6\u6627\u306a\u6b8b\u7559\u7269\u304c\u6b8b\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b<\/td>\n<\/tr>\n
\u30af\u30ed\u30de\u30c8\u30b0\u30e9\u30d5\u30a3\u30fc + MS<\/td>\n\u8cea\u91cf\u4fe1\u53f7\u306f\u5206\u89e3\u3055\u308c\u305f\u6210\u5206\u306b\u95a2\u9023\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u304b?<\/td>\n\u5171\u6eb6\u51fa\u3068\u30a4\u30aa\u30f3\u6291\u5236\u306b\u3088\u308a\u7a2e\u304c\u96a0\u853d\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

MS\/MS \u304c\u8ffd\u52a0\u3059\u308b\u3082\u306e<\/h2>\n

\u30bf\u30f3\u30c7\u30e0 MS \u306f\u524d\u99c6\u4f53\u3092\u5358\u96e2\u3057\u3001\u65ad\u7247\u5316\u3057\u307e\u3059\u3002\u4e00\u9023\u306e\u30d7\u30ed\u30c0\u30af\u30c8 \u30a4\u30aa\u30f3\u306f\u3001\u914d\u5217\u306e\u5404\u90e8\u5206\u306b\u308f\u305f\u308b\u6b8b\u57fa\u306e\u9806\u5e8f\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3001\u7279\u5b9a\u306e\u4fee\u98fe\u3092\u5c40\u5728\u5316\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u30ec\u30d3\u30e5\u30fc\u3067\u306f\u3001\u5358\u306b\u300c\u5408\u683c\u300d\u3068\u30de\u30fc\u30af\u3059\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u914d\u5217\u30ab\u30d0\u30ec\u30c3\u30b8\u3001\u8cea\u91cf\u30a8\u30e9\u30fc\u3001\u304a\u3088\u3073\u3042\u3044\u307e\u3044\u306a\u9818\u57df\u3092\u5831\u544a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u9ad8\u3044\u88ab\u8986\u7387\u306f\u5b8c\u5168\u306a\u69cb\u9020\u8a3c\u660e\u3068\u540c\u3058\u3067\u306f\u306a\u304f\u3001\u4e00\u90e8\u306e\u6b8b\u57fa\u307e\u305f\u306f\u4e0d\u5b89\u5b9a\u306a\u4fee\u98fe\u306b\u306f\u4ed6\u306e\u65b9\u6cd5\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n

\u96e3\u3057\u3044\u914d\u5217\u306e\u5834\u5408\u306f\u3001\u76f8\u88dc\u7684\u65ad\u7247\u5316\u3001\u30da\u30d7\u30c1\u30c9\u30de\u30c3\u30d4\u30f3\u30b0\u3001\u30a2\u30df\u30ce\u9178\u5206\u6790\u3001\u307e\u305f\u306f\u5225\u306e\u76f4\u4ea4\u3059\u308b\u6280\u8853\u304c\u9069\u5207\u306a\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u30e1\u30bd\u30c3\u30c9\u30bb\u30c3\u30c8\u306f\u3001\u56fa\u5b9a\u3055\u308c\u305f\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3067\u306f\u306a\u304f\u3001\u30a2\u30a4\u30c7\u30f3\u30c6\u30a3\u30c6\u30a3\u30ea\u30b9\u30af\u3068\u4ed5\u69d8\u306b\u5f93\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

\u30ed\u30c3\u30c8\u56fa\u6709\u306e LC-MS \u30ec\u30b3\u30fc\u30c9\u3092\u691c\u67fb\u3059\u308b\u65b9\u6cd5<\/h2>\n
    \n
  1. \u30b5\u30f3\u30d7\u30eb\u540d\u3068\u30ed\u30c3\u30c8\u3092COA\u3068\u53d6\u5f97\u8a18\u9332\u3068\u7167\u5408\u3057\u307e\u3059\u3002<\/li>\n
  2. \u6a5f\u5668\u306e\u30e2\u30fc\u30c9\u3001\u30a4\u30aa\u30f3\u5316\u3001\u8cea\u91cf\u7bc4\u56f2\u3001\u5206\u89e3\u80fd\u3092\u7279\u5b9a\u3057\u307e\u3059\u3002<\/li>\n
  3. \u5831\u544a\u3055\u308c\u305f\u5024\u304c\u30e2\u30ce\u30a2\u30a4\u30bd\u30c8\u30d4\u30c3\u30af\u3067\u3042\u308b\u304b\u5e73\u5747\u3067\u3042\u308b\u304b\u3001\u304a\u3088\u3073\u3069\u306e\u30a4\u30aa\u30f3\u5f0f\u304c\u8a08\u7b97\u3055\u308c\u305f\u304b\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/li>\n
  4. \u30c7\u30b3\u30f3\u30dc\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3055\u308c\u305f\u30b9\u30af\u30ea\u30fc\u30f3\u30b7\u30e7\u30c3\u30c8\u3060\u3051\u3067\u306a\u304f\u3001\u751f\u306e\u5145\u96fb\u72b6\u614b\u30a8\u30f3\u30d9\u30ed\u30fc\u30d7\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/li>\n
  5. \u6570\u5024\u4e0a\u306e\u89b3\u6e2c\u8cea\u91cf\u3001\u7406\u8ad6\u4e0a\u306e\u8cea\u91cf\u3001\u7d76\u5bfe\u8aa4\u5dee\u307e\u305f\u306f ppm \u8aa4\u5dee\u3001\u304a\u3088\u3073\u8a31\u5bb9\u57fa\u6e96\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/li>\n
  6. \u914d\u5217\u306e\u78ba\u8a8d\u304c\u4e3b\u5f35\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u306f\u3001\u30d5\u30e9\u30b0\u30e1\u30f3\u30c8\u306e\u5272\u308a\u5f53\u3066\u3001\u30ab\u30d0\u30ec\u30c3\u30b8\u3001\u304a\u3088\u3073\u672a\u89e3\u6c7a\u306e\u66d6\u6627\u3055\u3092\u691c\u67fb\u3057\u307e\u3059\u3002<\/li>\n
  7. \u30af\u30ed\u30de\u30c8\u30b0\u30e9\u30d5\u30a3\u30fc\u306e\u30b3\u30f3\u30c6\u30ad\u30b9\u30c8\u3092\u4f7f\u7528\u3057\u3066\u3001\u8ffd\u52a0\u306e\u6210\u5206\u307e\u305f\u306f\u5171\u6eb6\u51fa\u304c\u89b3\u5bdf\u3055\u308c\u305f\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3057\u307e\u3059\u3002<\/li>\n<\/ol>\n

    \u8eab\u5143\u8a3c\u62e0\u306f\u7d14\u5ea6\u3084\u5185\u5bb9\u3067\u306f\u3042\u308a\u307e\u305b\u3093<\/h2>\n

    \u6df7\u5408\u30b5\u30f3\u30d7\u30eb\u4e2d\u306e\u5fae\u91cf\u6210\u5206\u304b\u3089\u3001\u7d0d\u5f97\u306e\u3044\u304f\u30b9\u30da\u30af\u30c8\u30eb\u304c\u5f97\u3089\u308c\u307e\u3059\u3002\u9006\u306b\u3001\u652f\u914d\u7684\u306a HPLC \u30d4\u30fc\u30af\u306f\u305d\u308c\u81ea\u4f53\u3092\u8b58\u5225\u3057\u307e\u305b\u3093\u3002\u5b9a\u91cf\u7684\u306a\u5185\u5bb9\u306b\u306f\u9069\u5207\u306a\u30a2\u30c3\u30bb\u30a4\u304c\u5fc5\u8981\u3067\u3059\u3002\u30af\u30ed\u30de\u30c8\u30b0\u30e9\u30d5\u30a3\u30fc\u306e\u7d14\u5ea6\u306b\u306f\u3001\u5b9a\u7fa9\u3055\u308c\u305f\u5206\u96e2\u304a\u3088\u3073\u7d71\u5408\u65b9\u6cd5\u304c\u5fc5\u8981\u3067\u3059\u3002\u3053\u308c\u3089\u306e\u8a18\u9332\u306f\u3001\u305d\u308c\u305e\u308c\u306e\u500b\u5225\u306e\u610f\u5473\u3092\u4fdd\u6301\u3057\u306a\u304c\u3089\u4e00\u81f4\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n

    \u6700\u3082\u5f37\u529b\u306a\u77ed\u3044\u4e3b\u5f35\u306f\u5177\u4f53\u7684\u3067\u3059\u3002\u300c\u30d0\u30c3\u30c1\u8a18\u9332\u306f\u3001\u65b9\u6cd5 Y \u3067\u3001\u57fa\u6e96 Z \u5185\u3067\u89b3\u5bdf\u3055\u308c\u305f\u7121\u50b7\u306e X \u306e\u8cea\u91cf\u3092\u6dfb\u4ed8\u306e\u30b9\u30da\u30af\u30c8\u30eb\u3068\u3068\u3082\u306b\u5831\u544a\u3057\u307e\u3059\u3002\u300d\u3053\u308c\u3089\u306e\u30ed\u30c3\u30c8\u56fa\u6709\u306e\u8981\u7d20\u304c\u306a\u3051\u308c\u3070\u3001\u4e00\u822c\u7684\u306a LC-MS \u8aac\u660e\u8005\u306f\u89e3\u91c8\u3092\u6559\u3048\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u3059\u304c\u3001\u88fd\u54c1\u3092\u8a8d\u8a3c\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002<\/p>","protected":false},"excerpt":{"rendered":"

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This guide does not authenticate a sequence or catalog lot; interpretation requires the original method, raw data and sample traceability.","pim_review_status":"reviewed","pim_review_reason":"Primary regulatory guidance and peer-reviewed analytical sources with explicit lot-evidence boundaries.","pim_creation_method":"The editorial workflow starts with linked regulatory guidance and peer-reviewed analytical-method records; extracts scope, definitions, required fields and limitations; and separates general method principles from product- and lot-specific claims. AI-assisted drafting was used to structure the first version. Claims, examples and boundaries were checked against the linked records in the site editorial workflow. 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