Establishment of Quality Standard for Metaiodobenzylguanidine as Radiopharmaceutical Precursor
Meta-iodobenzylguanidine (MIBG) is used as a chemical precursor of radioiodinated (123I or 131I) MIBG preparation. In order to control the quality of MIBG, in this study, Infrared identification of self-made MIBG was carried out, the physical and chemical properties of solubility, pH, melting point...
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| Format: | Article |
| Language: | zho |
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Editorial Board of Journal of Isotopes
2023-02-01
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| Series: | Journal of Isotopes |
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| Online Access: | http://www.tws.org.cn/CN/10.7538/tws.2022.youxian.042 |
| _version_ | 1797830918601179136 |
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| author | CHEN Mengyi;DONG Ruilin;XING Yu;ZHOU Jiajun;QIU Shanshan;SUN Mingyue;WANG Xiaoming;WU Fuhai;HU Ji |
| author_facet | CHEN Mengyi;DONG Ruilin;XING Yu;ZHOU Jiajun;QIU Shanshan;SUN Mingyue;WANG Xiaoming;WU Fuhai;HU Ji |
| author_sort | CHEN Mengyi;DONG Ruilin;XING Yu;ZHOU Jiajun;QIU Shanshan;SUN Mingyue;WANG Xiaoming;WU Fuhai;HU Ji |
| collection | DOAJ |
| description | Meta-iodobenzylguanidine (MIBG) is used as a chemical precursor of radioiodinated (123I or 131I) MIBG preparation. In order to control the quality of MIBG, in this study, Infrared identification of self-made MIBG was carried out, the physical and chemical properties of solubility, pH, melting point and drying weight loss were determined, the content of elemental impurities was determined by ICP-MS, the headspace gas chromatography of residual solvent was established, and the content and related substances were determined by HPLC were established. The results for multiple batches of MIBG analysis showed that they met the requirements for medicinal precursors, the infrared spectrum of MIBG was consistent with that of the reference substance, the pH was in the range of 4.0-6.0, the melting point was 167-170 ℃, and the drying weight loss was less than 0.3%; ethanol residue was less than 0.5%, the content of elemental impurities was lower than the control threshold, together with no related impurities detected, and the contents of MIBG were 98.0%-102.0%. The quality standard of MIBG established in this study provides and provided basis for the quality control of MIBG. |
| first_indexed | 2024-04-09T13:43:58Z |
| format | Article |
| id | doaj.art-6339a988adeb4a53a2506ec15150da21 |
| institution | Directory Open Access Journal |
| issn | 1000-7512 |
| language | zho |
| last_indexed | 2024-04-09T13:43:58Z |
| publishDate | 2023-02-01 |
| publisher | Editorial Board of Journal of Isotopes |
| record_format | Article |
| series | Journal of Isotopes |
| spelling | doaj.art-6339a988adeb4a53a2506ec15150da212023-05-09T06:29:06ZzhoEditorial Board of Journal of IsotopesJournal of Isotopes1000-75122023-02-0136220321110.7538/tws.2022.youxian.042Establishment of Quality Standard for Metaiodobenzylguanidine as Radiopharmaceutical PrecursorCHEN Mengyi;DONG Ruilin;XING Yu;ZHOU Jiajun;QIU Shanshan;SUN Mingyue;WANG Xiaoming;WU Fuhai;HU Ji 0HTA Co., Ltd., BeijingMeta-iodobenzylguanidine (MIBG) is used as a chemical precursor of radioiodinated (123I or 131I) MIBG preparation. In order to control the quality of MIBG, in this study, Infrared identification of self-made MIBG was carried out, the physical and chemical properties of solubility, pH, melting point and drying weight loss were determined, the content of elemental impurities was determined by ICP-MS, the headspace gas chromatography of residual solvent was established, and the content and related substances were determined by HPLC were established. The results for multiple batches of MIBG analysis showed that they met the requirements for medicinal precursors, the infrared spectrum of MIBG was consistent with that of the reference substance, the pH was in the range of 4.0-6.0, the melting point was 167-170 ℃, and the drying weight loss was less than 0.3%; ethanol residue was less than 0.5%, the content of elemental impurities was lower than the control threshold, together with no related impurities detected, and the contents of MIBG were 98.0%-102.0%. The quality standard of MIBG established in this study provides and provided basis for the quality control of MIBG.http://www.tws.org.cn/CN/10.7538/tws.2022.youxian.042metaiodobenzylguanidineradiopharmaceutical precursorquality standardhplc |
| spellingShingle | CHEN Mengyi;DONG Ruilin;XING Yu;ZHOU Jiajun;QIU Shanshan;SUN Mingyue;WANG Xiaoming;WU Fuhai;HU Ji Establishment of Quality Standard for Metaiodobenzylguanidine as Radiopharmaceutical Precursor Journal of Isotopes metaiodobenzylguanidine radiopharmaceutical precursor quality standard hplc |
| title | Establishment of Quality Standard for Metaiodobenzylguanidine as Radiopharmaceutical Precursor |
| title_full | Establishment of Quality Standard for Metaiodobenzylguanidine as Radiopharmaceutical Precursor |
| title_fullStr | Establishment of Quality Standard for Metaiodobenzylguanidine as Radiopharmaceutical Precursor |
| title_full_unstemmed | Establishment of Quality Standard for Metaiodobenzylguanidine as Radiopharmaceutical Precursor |
| title_short | Establishment of Quality Standard for Metaiodobenzylguanidine as Radiopharmaceutical Precursor |
| title_sort | establishment of quality standard for metaiodobenzylguanidine as radiopharmaceutical precursor |
| topic | metaiodobenzylguanidine radiopharmaceutical precursor quality standard hplc |
| url | http://www.tws.org.cn/CN/10.7538/tws.2022.youxian.042 |
| work_keys_str_mv | AT chenmengyidongruilinxingyuzhoujiajunqiushanshansunmingyuewangxiaomingwufuhaihuji establishmentofqualitystandardformetaiodobenzylguanidineasradiopharmaceuticalprecursor |