Validation of an Analytical HPLC Method for a New Diagnostic Octreotide Derivative for Neuroendocrine Tumors
| Parent link: | Pharmaceutical Chemistry Journal Vol. 53, iss. 9.— 2019.— [P. 865-870] |
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| Andre forfattere: | , , , , , , , , |
| Summary: | Title screen Preclinical studies of a new octreotide derivative with a chelate (DPAH-octreotide) that binds 99mTc for radiological diagnosis of neuroendocrine tumors are currently in progress. A method for preparing DPAH-octreotide is based on forming an amide bond between the amine of D-phenylalanine and the bifunctional chelate succinimid-1-yl 6-[bis(pyridin-2-ylmethyl)amino]hexanoate. An HPLC method for determining the identity, impurities, and quantitative content is proposed for DPAH-octreotide quality assurance. The validationprotocol established that the HPLC analytical method for determining DPAH-octreotide had quality parameters for specificity, detection limit, linearity, accuracy, precision, and intralaboratory precision that met requirements for analytical methods and could be used for quality control of the finished product during manufacturing of reagents for preparation of related radiopharmaceuticals. Режим доступа: по договору с организацией-держателем ресурса |
| Udgivet: |
2019
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| Fag: | |
| Online adgang: | https://doi.org/10.1007/s11094-019-02091-z |
| Format: | Electronisk Book Chapter |
| KOHA link: | https://koha.lib.tpu.ru/cgi-bin/koha/opac-detail.pl?biblionumber=662001 |
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| 200 | 1 | |a Validation of an Analytical HPLC Method for a New Diagnostic Octreotide Derivative for Neuroendocrine Tumors |f M. S. Larkina, S. V. Krivoshchekov, E. V. Podrezova [et al.] | |
| 203 | |a Text |c electronic | ||
| 300 | |a Title screen | ||
| 320 | |a [References: 10 tit.] | ||
| 330 | |a Preclinical studies of a new octreotide derivative with a chelate (DPAH-octreotide) that binds 99mTc for radiological diagnosis of neuroendocrine tumors are currently in progress. A method for preparing DPAH-octreotide is based on forming an amide bond between the amine of D-phenylalanine and the bifunctional chelate succinimid-1-yl 6-[bis(pyridin-2-ylmethyl)amino]hexanoate. An HPLC method for determining the identity, impurities, and quantitative content is proposed for DPAH-octreotide quality assurance. The validationprotocol established that the HPLC analytical method for determining DPAH-octreotide had quality parameters for specificity, detection limit, linearity, accuracy, precision, and intralaboratory precision that met requirements for analytical methods and could be used for quality control of the finished product during manufacturing of reagents for preparation of related radiopharmaceuticals. | ||
| 333 | |a Режим доступа: по договору с организацией-держателем ресурса | ||
| 461 | |t Pharmaceutical Chemistry Journal | ||
| 463 | |t Vol. 53, iss. 9 |v [P. 865-870] |d 2019 | ||
| 610 | 1 | |a электронный ресурс | |
| 610 | 1 | |a труды учёных ТПУ | |
| 610 | 1 | |a octreotide derivative | |
| 610 | 1 | |a chelate | |
| 610 | 1 | |a technetium-99m | |
| 610 | 1 | |a HPLC | |
| 610 | 1 | |a validation | |
| 610 | 1 | |a хелаты | |
| 610 | 1 | |a технеций | |
| 610 | 1 | |a технеций-99м | |
| 701 | 1 | |a Larkina |b M. S. |g Mariya Sergeevna |f 1984- |c pharmacist |c Professor; Senior Researcher of the Tomsk Polytechnic University, Doctor of Pharmaceutical Sciences |3 (RuTPU)RU\TPU\pers\46781 |9 22417 | |
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| 701 | 1 | |a Podrezova |b E. V. |c Chemist |c Engineer of Tomsk Polytechnic University |f 1992- |g Ekaterina Vladimirovna |y Tomsk |3 (RuTPU)RU\TPU\pers\40301 |9 21290 | |
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