{"id":542,"date":"2026-08-27T18:00:00","date_gmt":"2026-08-27T18:00:00","guid":{"rendered":"https:\/\/nhdbio.com\/?p=542"},"modified":"2026-10-01T14:55:47","modified_gmt":"2026-10-01T14:55:47","slug":"%d9%86%d9%82%d8%a7%d8%a1-%d9%85%d9%86%d8%b7%d9%82%d8%a9-hplc-%d9%85%d9%82%d8%a7%d8%a8%d9%84-%d8%a7%d9%84%d9%83%d8%b3%d8%b1-%d8%a7%d9%84%d9%83%d8%aa%d9%84%d9%8a-%d9%84%d9%84%d8%a8%d8%a8%d8%aa%d9%8a","status":"publish","type":"post","link":"https:\/\/nhdbio.com\/ar\/hplc-area-purity-vs-assay-mass-fraction-peptide\/","title":{"rendered":"HPLC area purity vs quantitative assay: why does a single 99% peak not mean 99% peptide content?"},"content":{"rendered":"

\"99% pure by HPLC\" \u0647\u064a \u0648\u0627\u062d\u062f\u0629 \u0645\u0646 \u0623\u0643\u062b\u0631 \u0627\u0644\u0639\u0628\u0627\u0631\u0627\u062a \u0627\u0644\u062a\u064a \u064a\u0633\u0627\u0621 \u0641\u0647\u0645\u0647\u0627 \u0641\u064a \u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u0628\u0628\u062a\u064a\u062f. \u0641\u064a \u0633\u064a\u0627\u0642 \u062a\u0637\u0628\u064a\u0639 \u0627\u0644\u0645\u0646\u0637\u0642\u0629 \u0627\u0644\u0645\u0639\u062a\u0627\u062f\u060c \u0641\u0647\u0630\u0627 \u064a\u0639\u0646\u064a \u0623\u0646 \u0627\u0644\u0630\u0631\u0648\u0629 \u0627\u0644\u0631\u0626\u064a\u0633\u064a\u0629 \u0633\u0627\u0647\u0645\u062a \u0628\u062d\u0648\u0627\u0644\u064a 99% \u0645\u0646 \u0627\u0633\u062a\u062c\u0627\u0628\u0629 \u0627\u0644\u0643\u0627\u0634\u0641 \u0627\u0644\u0645\u062a\u0643\u0627\u0645\u0644 \u0628\u064a\u0646 \u0627\u0644\u0642\u0645\u0645 \u0627\u0644\u062a\u064a \u062a\u0645 \u062d\u0633\u0627\u0628\u0647\u0627 \u0628\u0648\u0627\u0633\u0637\u0629 \u062a\u0644\u0643 \u0627\u0644\u0637\u0631\u064a\u0642\u0629 \u0627\u0644\u0643\u0631\u0648\u0645\u0627\u062a\u0648\u063a\u0631\u0627\u0641\u064a\u0629. \u0647\u0630\u0627 \u0644\u0627 \u064a\u0639\u0646\u064a \u0623\u0646 99% \u0645\u0646 \u0643\u062a\u0644\u0629 \u0627\u0644\u0645\u0633\u062d\u0648\u0642 \u0647\u0648 \u0627\u0644\u0628\u0628\u062a\u064a\u062f \u0627\u0644\u0645\u0633\u062a\u0647\u062f\u0641.<\/p>\n

\u064a\u062a\u0628\u0639 \u0647\u0630\u0627 \u0627\u0644\u062a\u0645\u064a\u064a\u0632 \u0642\u0627\u0639\u062f\u0629 \u062a\u062d\u0644\u064a\u0644\u064a\u0629 \u0623\u0633\u0627\u0633\u064a\u0629 \u062a\u0646\u0639\u0643\u0633 \u0641\u064a ICH Q2 (R2)<\/a> \u0648 ICH Q14<\/a>: \u064a\u062c\u0628 \u0641\u0647\u0645 \u0627\u0644\u0625\u062c\u0631\u0627\u0621 \u0641\u064a\u0645\u0627 \u064a\u062a\u0639\u0644\u0642 \u0628\u0627\u0644\u063a\u0631\u0636 \u0627\u0644\u0645\u0642\u0635\u0648\u062f \u0645\u0646\u0647. \u064a\u0645\u0643\u0646 \u0644\u0645\u0644\u0641 \u062a\u0639\u0631\u064a\u0641 \u0627\u0644\u0634\u0648\u0627\u0626\u0628 \u0627\u0644\u0643\u0631\u0648\u0645\u0627\u062a\u0648\u063a\u0631\u0627\u0641\u064a \u0648\u0627\u0644\u0645\u0642\u0627\u064a\u0633\u0629 \u0627\u0644\u0643\u0645\u064a\u0629 \u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0645\u0639\u062f\u0627\u062a \u0645\u0645\u0627\u062b\u0644\u0629 \u0623\u062b\u0646\u0627\u0621 \u0627\u0644\u0625\u062c\u0627\u0628\u0629 \u0639\u0644\u0649 \u0623\u0633\u0626\u0644\u0629 \u0645\u062e\u062a\u0644\u0641\u0629.<\/p>\n

\u0645\u0627 \u0647\u064a \u0627\u0644\u0646\u0633\u0628\u0629 \u0627\u0644\u0645\u0626\u0648\u064a\u0629 \u0644\u0645\u0646\u0637\u0642\u0629 HPLC \u0627\u0644\u062a\u064a \u062a\u0642\u064a\u0633\u0647\u0627 \u0641\u0639\u0644\u064a\u064b\u0627<\/h2>\n

\u0641\u064a \u0627\u0644\u0631\u0633\u0645 \u0627\u0644\u0644\u0648\u0646\u064a UV \u0627\u0644\u0646\u0645\u0648\u0630\u062c\u064a\u060c \u064a\u0642\u0648\u0645 \u0627\u0644\u0628\u0631\u0646\u0627\u0645\u062c \u0628\u062f\u0645\u062c \u0627\u0644\u0642\u0645\u0645 \u0627\u0644\u0645\u062d\u062f\u062f\u0629. \u064a\u062a\u0645 \u062a\u0642\u0633\u064a\u0645 \u0645\u0646\u0637\u0642\u0629 \u0627\u0644\u0630\u0631\u0648\u0629 \u0627\u0644\u0631\u0626\u064a\u0633\u064a\u0629 \u0639\u0644\u0649 \u0625\u062c\u0645\u0627\u0644\u064a \u0627\u0644\u0645\u0633\u0627\u062d\u0629 \u0627\u0644\u0645\u0634\u0645\u0648\u0644\u0629. \u062a\u0639\u062a\u0645\u062f \u0647\u0630\u0647 \u0627\u0644\u0646\u0633\u0628\u0629 \u0639\u0644\u0649 \u0627\u0644\u0637\u0648\u0644 \u0627\u0644\u0645\u0648\u062c\u064a \u0644\u0644\u0643\u0627\u0634\u0641\u060c \u0648\u0625\u0639\u062f\u0627\u062f \u0627\u0644\u0639\u064a\u0646\u0629\u060c \u0648\u0627\u0644\u0639\u0645\u0648\u062f\u060c \u0648\u0627\u0644\u062a\u062f\u0631\u062c\u060c \u0648\u0625\u0639\u062f\u0627\u062f\u0627\u062a \u0627\u0644\u062a\u0643\u0627\u0645\u0644 \u0648\u0627\u0644\u0645\u0631\u0643\u0628\u0627\u062a \u0627\u0644\u062a\u064a \u062a\u0646\u062a\u062c \u0627\u0644\u0627\u0633\u062a\u062c\u0627\u0628\u0629. \u0642\u062f \u064a\u0633\u0627\u0647\u0645 \u0627\u0644\u0645\u0643\u0648\u0646 \u0627\u0644\u0630\u064a \u0644\u0627 \u064a\u062a\u0645 \u0627\u0645\u062a\u0635\u0627\u0635\u0647 \u0639\u0646\u062f \u0627\u0644\u0637\u0648\u0644 \u0627\u0644\u0645\u0648\u062c\u064a \u0627\u0644\u0645\u062d\u062f\u062f \u0641\u064a \u0627\u0644\u0643\u062a\u0644\u0629 \u062f\u0648\u0646 \u0623\u0646 \u064a\u0638\u0647\u0631 \u0643\u0630\u0631\u0648\u0629 \u0642\u0627\u0628\u0644\u0629 \u0644\u0644\u0645\u0642\u0627\u0631\u0646\u0629.<\/p>\n

\u0648\u0645\u0646 \u0627\u0644\u0623\u0645\u062b\u0644\u0629 \u0627\u0644\u0648\u0627\u0636\u062d\u0629 \u0639\u0644\u0649 \u0630\u0644\u0643 \u0627\u0644\u0645\u0627\u0621 \u0648\u0627\u0644\u0639\u062f\u064a\u062f \u0645\u0646 \u0627\u0644\u0623\u0645\u0644\u0627\u062d \u063a\u064a\u0631 \u0627\u0644\u0639\u0636\u0648\u064a\u0629 \u0648\u0628\u0639\u0636 \u0627\u0644\u0645\u0633\u0627\u0647\u0645\u0627\u062a \u0627\u0644\u0645\u0636\u0627\u062f\u0629. \u062d\u062a\u0649 \u0628\u064a\u0646 \u0627\u0644\u0645\u0631\u0643\u0628\u0627\u062a \u0627\u0644\u0646\u0634\u0637\u0629 UV\u060c \u0641\u0625\u0646 \u0627\u0644\u0643\u062a\u0644\u0629 \u0627\u0644\u0645\u062a\u0633\u0627\u0648\u064a\u0629 \u0644\u0627 \u062a\u0636\u0645\u0646 \u0627\u0633\u062a\u062c\u0627\u0628\u0629 \u0645\u062a\u0633\u0627\u0648\u064a\u0629 \u0644\u0644\u0643\u0627\u0634\u0641. \u064a\u0645\u0643\u0646 \u0644\u0644\u0634\u0637\u0641 \u0627\u0644\u0645\u0634\u062a\u0631\u0643 \u0623\u0646 \u064a\u062c\u0645\u0639 \u0627\u0644\u0645\u0643\u0648\u0646\u0627\u062a \u0641\u064a \u0642\u0645\u0629 \u0648\u0627\u062d\u062f\u0629\u061b \u064a\u0645\u0643\u0646 \u0627\u0633\u062a\u0628\u0639\u0627\u062f \u0627\u0644\u0634\u0648\u0627\u0626\u0628 \u0627\u0644\u062a\u064a \u062a\u0642\u0644 \u0639\u0646 \u0639\u062a\u0628\u0629 \u0627\u0644\u0625\u0628\u0644\u0627\u063a\u061b \u0642\u062f \u064a\u062a\u0645 \u062a\u062c\u0627\u0647\u0644 \u062c\u0628\u0647\u0629 \u0627\u0644\u0645\u0630\u064a\u0628\u0627\u062a \u0627\u0644\u0645\u0628\u0643\u0631\u0629 \u062c\u062f\u064b\u0627. \u0648\u0644\u0630\u0644\u0643\u060c \u0641\u0625\u0646 \u062a\u0637\u0628\u064a\u0639 \u0627\u0644\u0645\u0646\u0637\u0642\u0629 \u0647\u0648 \u0645\u0644\u0641 \u062a\u0639\u0631\u064a\u0641 \u0643\u0631\u0648\u0645\u0627\u062a\u0648\u063a\u0631\u0627\u0641\u064a \u0645\u0641\u064a\u062f\u060c \u0648\u0644\u064a\u0633 \u0627\u062e\u062a\u0628\u0627\u0631\u064b\u0627 \u0648\u0632\u0646\u064a\u064b\u0627 \u0639\u0627\u0644\u0645\u064a\u064b\u0627.<\/p>\n

\u0627\u0644\u0646\u0642\u0627\u0621 \u0648\u0627\u0644\u0645\u0642\u0627\u064a\u0633\u0629 \u0648\u0627\u0644\u0645\u062d\u062a\u0648\u0649 \u0647\u064a \u0643\u0645\u064a\u0627\u062a \u0645\u0646\u0641\u0635\u0644\u0629<\/h2>\n
\n\n\n\n\n\n\n\n\n
\u0627\u0644\u0642\u064a\u0645\u0629 \u0627\u0644\u0645\u0628\u0644\u063a \u0639\u0646\u0647\u0627<\/th>\n\u062a\u0645\u062a \u0627\u0644\u0625\u062c\u0627\u0628\u0629 \u0639\u0644\u0649 \u0627\u0644\u0633\u0624\u0627\u0644<\/th>\n\u0645\u0627 \u0644\u0627 \u064a\u062b\u0628\u062a \u0648\u062d\u062f\u0647<\/th>\n<\/tr>\n<\/thead>\n
\u0645\u0646\u0637\u0642\u0629 \u0627\u0644\u0630\u0631\u0648\u0629 \u0627\u0644\u0631\u0626\u064a\u0633\u064a\u0629 HPLC\u066a<\/td>\n\u0645\u0627 \u0645\u062f\u0649 \u0647\u064a\u0645\u0646\u0629 \u0627\u0644\u0630\u0631\u0648\u0629 \u0627\u0644\u0631\u0626\u064a\u0633\u064a\u0629 \u0627\u0644\u0645\u0643\u062a\u0634\u0641\u0629 \u0628\u0645\u0648\u062c\u0628 \u0647\u0630\u0647 \u0627\u0644\u0637\u0631\u064a\u0642\u0629\u061f<\/td>\n\u0627\u0644\u0647\u062f\u0641 \u0647\u0648 \u062c\u0632\u0621 \u0627\u0644\u0643\u062a\u0644\u0629 \u0623\u0648 \u0627\u0644\u0647\u0648\u064a\u0629 \u0623\u0648 \u0627\u0644\u0645\u0627\u0621 \u0623\u0648 \u0643\u0645\u064a\u0629 \u0627\u0644\u0639\u062f\u0627\u062f<\/td>\n<\/tr>\n
\u0641\u062d\u0635<\/td>\n\u0645\u0627 \u0647\u064a \u0643\u0645\u064a\u0629 \u0627\u0644\u0645\u0627\u062f\u0629 \u0627\u0644\u062a\u062d\u0644\u064a\u0644\u064a\u0629 \u0627\u0644\u0645\u0648\u062c\u0648\u062f\u0629 \u0645\u0642\u0627\u0631\u0646\u0629 \u0628\u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0627\u0644\u0645\u0646\u0627\u0633\u0628 \u0648\u0627\u0644\u0623\u0633\u0627\u0633 \u0627\u0644\u0645\u0639\u0644\u0646\u061f<\/td>\n\u0643\u0644 \u0646\u062c\u0627\u0633\u0629 \u0647\u0648\u064a\u0629 \u0623\u0648 \u062a\u0633\u0644\u0633\u0644 \u0643\u0627\u0645\u0644<\/td>\n<\/tr>\n
\u0627\u0644\u0645\u0627\u0621 \/ \u0627\u0644\u0645\u062d\u062a\u0648\u0649 \u0627\u0644\u0645\u062a\u0637\u0627\u064a\u0631<\/td>\n\u0645\u0627 \u0645\u0642\u062f\u0627\u0631 \u0627\u0644\u0643\u062a\u0644\u0629 \u063a\u064a\u0631 \u0627\u0644\u062a\u062d\u0644\u064a\u0644\u064a\u0629 \u0627\u0644\u0645\u062d\u062f\u062f\u0629 \u0627\u0644\u0645\u0648\u062c\u0648\u062f\u0629\u061f<\/td>\n\u0627\u0644\u0646\u0642\u0627\u0621 \u0627\u0644\u0643\u0631\u0648\u0645\u0627\u062a\u0648\u063a\u0631\u0627\u0641\u064a \u0623\u0648 \u0647\u0648\u064a\u0629 \u0627\u0644\u0628\u0628\u062a\u064a\u062f<\/td>\n<\/tr>\n
\u0646\u062a\u064a\u062c\u0629 \u0645\u0636\u0627\u062f\u0629<\/td>\n\u0645\u0627 \u0647\u064a \u0643\u0645\u064a\u0629 \u0627\u0644\u0623\u0633\u064a\u062a\u0627\u062a \u0623\u0648 TFA \u0623\u0648 \u0627\u0644\u0623\u064a\u0648\u0646\u0627\u062a \u0627\u0644\u0623\u062e\u0631\u0649 \u0627\u0644\u062a\u064a \u062a\u0645 \u0642\u064a\u0627\u0633\u0647\u0627\u061f<\/td>\n\u0625\u062c\u0645\u0627\u0644\u064a \u0627\u0644\u0645\u062d\u062a\u0648\u0649 \u0627\u0644\u0645\u0633\u062a\u0647\u062f\u0641 \u0645\u0627 \u0644\u0645 \u064a\u062a\u0645 \u062f\u0645\u062c\u0647 \u0645\u0639 \u0628\u0642\u064a\u0629 \u0627\u0644\u062a\u0643\u0648\u064a\u0646<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

\u0639\u0645\u0644\u064a\u0629 \u062d\u0633\u0627\u0628\u064a\u0629 \u0627\u0641\u062a\u0631\u0627\u0636\u064a\u0629 \u0634\u0641\u0627\u0641\u0629<\/h2>\n

\u0644\u0646\u0641\u062a\u0631\u0636 - \u0648\u0644\u064a\u0633 \u0643\u0646\u062a\u064a\u062c\u0629 \u062d\u0642\u064a\u0642\u064a\u0629 - \u0623\u0646\u0647 \u062a\u0645 \u0627\u0644\u0625\u0628\u0644\u0627\u063a \u0639\u0646 \u0627\u0644\u0645\u0633\u062d\u0648\u0642 \u0639\u0644\u0649 \u0623\u0646\u0647 \u0645\u0646\u0637\u0642\u0629 \u0627\u0644\u0630\u0631\u0648\u0629 \u0627\u0644\u0631\u0626\u064a\u0633\u064a\u0629 99.2% HPLC. \u0642\u064a\u0627\u0633\u0627\u062a \u0645\u0646\u0641\u0635\u0644\u0629 \u062a\u062c\u062f 6.0% \u0627\u0644\u0645\u0627\u0621 \u06488.0% \u0627\u0644\u0639\u062f\u0627\u062f \u0628\u0627\u0644\u0643\u062a\u0644\u0629. \u0633\u064a\u0643\u0648\u0646 \u0645\u0646 \u0627\u0644\u062e\u0637\u0623 \u062a\u0633\u0645\u064a\u0629 \u0627\u0644\u0645\u0633\u062d\u0648\u0642 \u0628\u0645\u062d\u062a\u0648\u0649 \u0627\u0644\u0628\u0628\u062a\u064a\u062f 99.2%. \u0648\u062d\u062a\u0649 \u0642\u0628\u0644 \u062d\u0633\u0627\u0628 \u0627\u0644\u0645\u062e\u0644\u0641\u0627\u062a \u0627\u0644\u0623\u062e\u0631\u0649\u060c \u0641\u0625\u0646 \u0627\u0644\u0643\u062a\u0644\u0629 \u063a\u064a\u0631 \u0627\u0644\u0628\u0628\u062a\u064a\u062f\u064a\u0629 \u062a\u063a\u064a\u0631 \u0628\u0627\u0644\u0641\u0639\u0644 \u0627\u0644\u0645\u062d\u062a\u0648\u0649 \u0627\u0644\u0635\u0627\u0641\u064a \u0627\u0644\u0645\u062d\u062a\u0645\u0644.<\/p>\n

\u064a\u0639\u062a\u0645\u062f \u0627\u0644\u062d\u0633\u0627\u0628 \u0627\u0644\u062f\u0642\u064a\u0642 \u0639\u0644\u0649 \u0643\u064a\u0641\u064a\u0629 \u062a\u0639\u0631\u064a\u0641 \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631: \u0627\u0644\u0623\u0633\u0627\u0633 \u0643\u0645\u0627 \u0647\u0648\u060c \u0627\u0644\u0623\u0633\u0627\u0633 \u0627\u0644\u0644\u0627\u0645\u0627\u0626\u064a\u060c \u0627\u0644\u0623\u0633\u0627\u0633 \u0627\u0644\u0645\u0635\u062d\u062d \u0627\u0644\u0645\u0636\u0627\u062f\u060c \u0645\u0643\u0627\u0641\u0626 \u0627\u0644\u0628\u0628\u062a\u064a\u062f \u0627\u0644\u062d\u0631 \u0623\u0648 \u0645\u0648\u0627\u0635\u0641\u0627\u062a \u0623\u062e\u0631\u0649. \u064a\u062c\u0628 \u0623\u0646 \u062a\u0633\u0645\u064a \u0627\u0644\u0634\u0647\u0627\u062f\u0629 \u0647\u0630\u0627 \u0627\u0644\u0623\u0633\u0627\u0633. \u0628\u062e\u0644\u0627\u0641 \u0630\u0644\u0643\u060c \u064a\u0645\u0643\u0646 \u0623\u0646 \u064a\u0638\u0647\u0631 \u0631\u0642\u0645\u0627\u0646 \u0635\u062d\u064a\u062d\u0627\u0646 \u0631\u064a\u0627\u0636\u064a\u064b\u0627 \u0645\u062a\u0646\u0627\u0642\u0636\u064a\u0646 \u0639\u0646\u062f\u0645\u0627 \u064a\u062a\u0645 \u062a\u0637\u0628\u064a\u0639\u0647\u0645\u0627 \u0628\u0634\u0643\u0644 \u0645\u062e\u062a\u0644\u0641.<\/p>\n

\u0644\u0645\u0627\u0630\u0627 \u062a\u0639\u062a\u0628\u0631 \u0627\u0644\u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u0645\u0631\u062c\u0639\u064a\u0629 \u0648\u0639\u0648\u0627\u0645\u0644 \u0627\u0644\u0627\u0633\u062a\u062c\u0627\u0628\u0629 \u0645\u0647\u0645\u0629\u061f<\/h2>\n

\u064a\u062d\u062a\u0627\u062c \u0627\u0644\u0641\u062d\u0635 \u0627\u0644\u0643\u0645\u064a \u0625\u0644\u0649 \u0645\u0631\u062c\u0639 \u0645\u0646\u0627\u0633\u0628 \u0648\u0639\u0644\u0627\u0642\u0629 \u0645\u062d\u0643\u0648\u0645\u0629 \u0628\u064a\u0646 \u0627\u0644\u0625\u0634\u0627\u0631\u0629 \u0648\u0627\u0644\u0645\u0628\u0644\u063a. \u062a\u0633\u0627\u0647\u0645 \u0647\u0648\u064a\u0629 \u0623\u0648 \u0646\u0642\u0627\u0621 \u0627\u0644\u0645\u0631\u062c\u0639 \u0648\u062f\u0642\u0629 \u0627\u0644\u0625\u0639\u062f\u0627\u062f \u0648\u0646\u0645\u0648\u0630\u062c \u0627\u0644\u0645\u0639\u0627\u064a\u0631\u0629 \u0648\u062a\u0623\u062b\u064a\u0631\u0627\u062a \u0627\u0644\u0645\u0635\u0641\u0648\u0641\u0629 \u0641\u064a \u0639\u062f\u0645 \u0627\u0644\u064a\u0642\u064a\u0646. \u0642\u062f \u062a\u0634\u0645\u0644 \u062e\u0635\u0627\u0626\u0635 \u0627\u0644\u062a\u062d\u0642\u0642 \u0630\u0627\u062a \u0627\u0644\u0635\u0644\u0629 \u0628\u0627\u0644\u0637\u0631\u064a\u0642\u0629 \u0627\u0644\u062e\u0635\u0648\u0635\u064a\u0629 \u0648\u0627\u0644\u062f\u0642\u0629 \u0648\u0627\u0644\u062f\u0642\u0629 \u0648\u0627\u0644\u0645\u062f\u0649 \u0648\u0627\u0644\u0645\u062a\u0627\u0646\u0629. \u0644\u0627 \u064a\u064f\u0638\u0647\u0631 \u0625\u062f\u0631\u0627\u062c \"HPLC\" \u0641\u064a \u062d\u062f \u0630\u0627\u062a\u0647 \u0623\u0646 \u0647\u0630\u0647 \u0627\u0644\u062e\u0635\u0627\u0626\u0635 \u0642\u062f \u062a\u0645 \u062a\u062d\u062f\u064a\u062f\u0647\u0627 \u0644\u0645\u0637\u0627\u0644\u0628\u0629 \u0645\u062d\u062a\u0648\u0649 \u0643\u0645\u064a.<\/p>\n

\u0623\u0633\u0626\u0644\u0629 \u064a\u062c\u0628 \u0637\u0631\u062d\u0647\u0627 \u0639\u0646\u062f\u0645\u0627 \u064a\u0642\u0648\u0644 \u0627\u0644\u0639\u0646\u0648\u0627\u0646 99%<\/h2>\n
    \n
  1. \u0647\u0644 99% \u0647\u064a \u0646\u062a\u064a\u062c\u0629 \u0645\u0646\u0637\u0642\u0629 \u0627\u0644\u0630\u0631\u0648\u0629 \u0627\u0644\u0631\u0626\u064a\u0633\u064a\u0629\u060c \u0623\u0648 \u0627\u062e\u062a\u0628\u0627\u0631 \u0645\u0639\u0627\u064a\u0631\u0629\u060c \u0623\u0648 \u062d\u062f \u0627\u0644\u0645\u0648\u0627\u0635\u0641\u0627\u062a\u061f<\/li>\n
  2. \u0645\u0627 \u0647\u064a \u0642\u0648\u0627\u0639\u062f \u0627\u0644\u0643\u0627\u0634\u0641 \u0648\u0627\u0644\u0637\u0648\u0644 \u0627\u0644\u0645\u0648\u062c\u064a \u0648\u0627\u0644\u062a\u0643\u0627\u0645\u0644 \u0627\u0644\u062a\u064a \u062a\u0645 \u0627\u0633\u062a\u062e\u062f\u0627\u0645\u0647\u0627\u061f<\/li>\n
  3. \u0647\u0644 \u062a\u0645 \u062d\u0644 \u0627\u0644\u0634\u0648\u0627\u0626\u0628 \u0627\u0644\u0645\u0631\u062a\u0628\u0637\u0629 \u0628\u0627\u0644\u0628\u0628\u062a\u064a\u062f \u0639\u0646 \u0643\u062b\u0628 \u0628\u0634\u0643\u0644 \u0645\u0646\u0627\u0633\u0628\u061f<\/li>\n
  4. \u0647\u0644 \u062a\u0645 \u0627\u0644\u0625\u0628\u0644\u0627\u063a \u0639\u0646 \u0627\u0644\u0646\u062a\u064a\u062c\u0629 \u0643\u0645\u0627 \u0647\u064a \u0623\u0645 \u062a\u0645 \u062a\u0635\u062d\u064a\u062d\u0647\u0627 \u0628\u0627\u0644\u0646\u0633\u0628\u0629 \u0644\u0644\u0645\u064a\u0627\u0647 \u0648\u0627\u0644\u0639\u062f\u0627\u062f\u0627\u062a\u061f<\/li>\n
  5. \u0645\u0627 \u0647\u0648 \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0627\u0644\u0645\u0631\u062c\u0639\u064a \u0648\u0635\u064a\u063a\u0629 \u0627\u0644\u062d\u0633\u0627\u0628 \u0627\u0644\u062a\u064a \u062a\u062f\u0639\u0645 \u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631\u061f<\/li>\n
  6. \u0647\u0644 \u062a\u0643\u0645\u0644 \u0646\u062a\u0627\u0626\u062c \u0627\u0644\u0645\u0627\u0621 \u0648\u0627\u0644\u0623\u0643\u0633\u062f\u0629 \u0648\u0627\u0644\u0645\u0630\u064a\u0628\u0627\u062a \u0627\u0644\u0645\u062a\u0628\u0642\u064a\u0629 \u0648\u0627\u0644\u0628\u0642\u0627\u064a\u0627 \u063a\u064a\u0631 \u0627\u0644\u0639\u0636\u0648\u064a\u0629 \u0635\u0648\u0631\u0629 \u062a\u0648\u0627\u0632\u0646 \u0627\u0644\u0643\u062a\u0644\u0629\u061f<\/li>\n<\/ol>\n

    \u0643\u064a\u0641\u064a\u0629 \u0643\u062a\u0627\u0628\u0629 \u0627\u0644\u0645\u0637\u0627\u0644\u0628\u0629 \u0628\u062f\u0642\u0629<\/h2>\n

    \u0625\u0630\u0627 \u0643\u0627\u0646 \u0627\u0644\u062f\u0644\u064a\u0644 \u0627\u0644\u0645\u062a\u0627\u062d \u0639\u0628\u0627\u0631\u0629 \u0639\u0646 \u0645\u062e\u0637\u0637 \u0643\u0631\u0648\u0645\u0627\u062a\u0648\u062c\u0631\u0627\u0645 \u0641\u0642\u0637\u060c \u0641\u0625\u0646 \u0627\u0644\u0635\u064a\u0627\u063a\u0629 \u0627\u0644\u062a\u064a \u064a\u0645\u0643\u0646 \u0627\u0644\u062f\u0641\u0627\u0639 \u0639\u0646\u0647\u0627 \u0647\u064a \"\u0645\u0646\u0637\u0642\u0629 \u0627\u0644\u0630\u0631\u0648\u0629 \u0627\u0644\u0631\u0626\u064a\u0633\u064a\u0629 \u0628\u0648\u0627\u0633\u0637\u0629 \u0637\u0631\u064a\u0642\u0629 HPLC \u0627\u0644\u0645\u0630\u0643\u0648\u0631\u0629\"\u060c \u0645\u0635\u062d\u0648\u0628\u0629 \u0628\u0627\u0644\u0637\u0631\u064a\u0642\u0629 \u0648\u0627\u0644\u062f\u0641\u0639\u0629 \u0648\u0627\u0644\u0646\u062a\u064a\u062c\u0629. \u064a\u062c\u0628 \u062d\u062c\u0632 \"\u0645\u062d\u062a\u0648\u0649 \u0627\u0644\u0628\u0628\u062a\u064a\u062f\" \u0644\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0646\u062a\u064a\u062c\u0629 \u0643\u0645\u064a\u0629 \u064a\u062a\u0645 \u0630\u0643\u0631 \u0623\u0633\u0627\u0633\u0647\u0627. \u064a\u062c\u0628 \u0623\u0646 \u062a\u0643\u0648\u0646 \"\u0627\u0644\u0646\u0642\u0627\u0621\" \u0645\u0624\u0647\u0644\u0629 \u062d\u062a\u0649 \u064a\u0639\u0631\u0641 \u0627\u0644\u0642\u0631\u0627\u0621 \u0645\u0627 \u0625\u0630\u0627 \u0643\u0627\u0646 \u0630\u0644\u0643 \u0645\u0642\u064a\u0627\u0633\u064b\u0627 \u0643\u0631\u0648\u0645\u0627\u062a\u0648\u063a\u0631\u0627\u0641\u064a\u064b\u0627 \u0623\u0648 \u0643\u064a\u0645\u064a\u0627\u0626\u064a\u064b\u0627 \u0623\u0648 \u0623\u064a \u0645\u0642\u064a\u0627\u0633 \u0622\u062e\u0631 \u0645\u062d\u062f\u062f.<\/p>\n

    \u0647\u0630\u0647 \u0627\u0644\u0644\u063a\u0629 \u0627\u0644\u062f\u0642\u064a\u0642\u0629 \u0644\u064a\u0633\u062a \u062a\u062d\u0630\u0644\u0642\u064b\u0627. \u0641\u0647\u0648 \u064a\u0645\u0646\u0639 \u0627\u0644\u0637\u0631\u064a\u0642\u0629 \u0645\u0646 \u0623\u0646 \u064a\u064f\u0637\u0644\u0628 \u0645\u0646\u0647\u0627 \u0625\u062b\u0628\u0627\u062a \u0633\u0645\u0629 \u0644\u0645 \u064a\u062a\u0645 \u062a\u0635\u0645\u064a\u0645\u0647\u0627 \u0644\u0642\u064a\u0627\u0633\u0647\u0627 \u0645\u0637\u0644\u0642\u064b\u0627\u060c \u0643\u0645\u0627 \u0623\u0646\u0647\u0627 \u062a\u062c\u0639\u0644 \u0627\u0644\u0645\u0648\u0631\u062f\u064a\u0646 \u0627\u0644\u0645\u062e\u062a\u0644\u0641\u064a\u0646 \u0623\u0648 \u0627\u0644\u0643\u0645\u064a\u0627\u062a \u0642\u0627\u0628\u0644\u0629 \u0644\u0644\u0645\u0642\u0627\u0631\u0646\u0629 \u0628\u0634\u0643\u0644 \u0645\u0641\u064a\u062f.<\/p>","protected":false},"excerpt":{"rendered":"

    \u0627\u0644\u0646\u0633\u0628\u0629 \u0627\u0644\u0645\u0626\u0648\u064a\u0629 \u0644\u0645\u0633\u0627\u062d\u0629 HPLC \u0648\u0627\u0644\u0645\u0642\u0627\u064a\u0633\u0629 \u0648\u0645\u062d\u062a\u0648\u0649 \u0627\u0644\u0628\u0628\u062a\u064a\u062f \u0627\u0644\u0635\u0627\u0641\u064a \u062a\u062c\u064a\u0628 \u0639\u0644\u0649 \u0623\u0633\u0626\u0644\u0629 \u0645\u062e\u062a\u0644\u0641\u0629. \u0625\u0644\u064a\u0643 \u0643\u064a\u0641\u064a\u0629 \u062a\u063a\u064a\u064a\u0631 \u0627\u0633\u062a\u062c\u0627\u0628\u0629 \u0627\u0644\u0643\u0627\u0634\u0641 \u0648\u0627\u0644\u0645\u0627\u0621 \u0648\u0627\u0644\u0623\u0636\u062f\u0627\u062f \u0641\u064a \u0627\u0644\u062a\u0641\u0633\u064a\u0631.<\/p>","protected":false},"author":1,"featured_media":2787,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"pim_family_ids":"","pim_article_type":"Quality documentation guide","pim_evidence_level":"ICH Q2(R2)\/Q14 analytical principles and FDA synthetic-peptide guidance; no lot-specific result","pim_reviewer":"NHD evidence editorial workflow","pim_reviewed_date":"2026-08-28","pim_editorial_note":"The numerical examples are transparent calculations, not test results for a catalog material. Only a validated lot-specific method and record can establish actual content.","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. This is not independent peer review or evidence that any catalog lot has passed the tests described.","pim_sources":"[{\"title\":\"ICH Q2(R2): Validation of Analytical Procedures\",\"url\":\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q2r2-validation-analytical-procedures\",\"note\":\"Defines validation characteristics and distinguishes quantitative analytical purposes.\"},{\"title\":\"ICH Q14: Analytical Procedure Development\",\"url\":\"https:\/\/database.ich.org\/sites\/default\/files\/ICH_Q14_Guideline_2023_1116.pdf\",\"note\":\"Explains method purpose, performance characteristics and scientifically sound procedure development.\"},{\"title\":\"FDA: Analytical Procedures and Methods Validation for Drugs and Biologics\",\"url\":\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/analytical-procedures-and-methods-validation-drugs-and-biologics\",\"note\":\"Official guidance on analytical method submission and validation expectations.\"},{\"title\":\"FDA: ANDAs for Certain Highly Purified Synthetic Peptide Drug Products\",\"url\":\"https:\/\/www.fda.gov\/media\/107622\/download\",\"note\":\"Discusses peptide-related impurities and why robust analytical characterization matters.\"}]","footnotes":""},"categories":[21],"tags":[],"class_list":["post-542","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-quality-documentation-guides"],"yoast_head":"\nHPLC Area Purity vs Assay: The 99% Peptide Problem<\/title>\n<meta name=\"description\" content=\"Understand why 99% HPLC area purity is not automatically 99% peptide by mass, and which assay, water and counterion data are needed for net content.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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