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1دورية أكاديمية
المؤلفون: Hemanth P.R. Vikram, Tegginamath Pramod Kumar, Gunjan Kumar, Narasimha M. Beeraka, Rajashree Deka, Sheik Mohammed Suhail, Sandeep Jat, Namitha Bannimath, Gayatiri Padmanabhan, Ravandur S. Chandan, Pramod Kumar, Bannimath Gurupadayya
المصدر: Journal of Pharmaceutical Analysis, Vol 14, Iss 5, Pp 100919- (2024)
مصطلحات موضوعية: Carcinogenicity, Genotoxicity, Mutagenicity, Molecular toxicity, Nitrosamine impurities, Nitrosamine drug substance-related impurities, Therapeutics. Pharmacology, RM1-950
وصف الملف: electronic resource
العلاقة: http://www.sciencedirect.com/science/article/pii/S2095177923002927Test; https://doaj.org/toc/2095-1779Test
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2دورية أكاديمية
المؤلفون: Kiichi Hirohata, Yuki Yamaguchi, Takahiro Maruno, Risa Shibuya, Tetsuo Torisu, Takayuki Onishi, Hideto Chono, Junichi Mineno, Yuan Yuzhe, Kiyoko Higashiyama, Kyoko Masumi-Koizumi, Kazuhisa Uchida, Takenori Yamamoto, Eriko Uchida, Takashi Okada, Susumu Uchiyama
مصطلحات موضوعية: Biophysics, Microbiology, Cell Biology, Genetics, Molecular Biology, Ecology, Immunology, Marine Biology, Cancer, Infectious Diseases, Space Science, Biological Sciences not elsewhere classified, Chemical Sciences not elsewhere classified, Physical Sciences not elsewhere classified, sedimentation velocity auc, modern auc instrument, band sedimentation auc, different dna lengths, particle without dna, designed dna, different serotypes, auc experiments, auc enabled, full particle, empty particle, desired particle, separated peaks, reliable assessment, related impurities, quantitative ability
الإتاحة: https://doi.org/10.1021/acs.analchem.3c01955.s001Test
https://figshare.com/articles/journal_contribution/Applications_and_Limitations_of_Equilibrium_Density_Gradient_Analytical_Ultracentrifugation_for_the_Quantitative_Characterization_of_Adeno-Associated_Virus_Vectors/24925762Test -
3دورية أكاديمية
المؤلفون: Zezhou Ding, Ruijie Quan, Bibo Jiang, Jingjing Xiang, Qian Wang, Anjiang Yang, Tao Zhang, Fuli Zhang
مصطلحات موضوعية: Biochemistry, Medicine, Cell Biology, Genetics, Molecular Biology, Biotechnology, Developmental Biology, Biological Sciences not elsewhere classified, Physical Sciences not elsewhere classified, Information Systems not elsewhere classified, impurity control strategy, purity penehyclidine hydrochloride, penehyclidine hydrochloride, impurity profile, successfully explored, related impurities, potentially boost, independently synthesized, impurities reported, fractional distillation, drug standard, critical parameters, could promote
الإتاحة: https://doi.org/10.1021/acs.oprd.3c00297.s001Test
https://figshare.com/articles/journal_contribution/Improved_Synthesis_and_Impurity_Control_Strategy_of_Penehyclidine_Hydrochloride/24947355Test -
4دورية أكاديمية
المؤلفون: Pranavkumar Shah, Sanjay Hadiyal, Bhavin Dhaduk
المصدر: Results in Chemistry, Vol 6, Iss , Pp 101022- (2023)
مصطلحات موضوعية: Selexipag, Pulmonary arterial hypertension (PHA), Related impurities, LC-MS/MS, Chemistry, QD1-999
وصف الملف: electronic resource
العلاقة: http://www.sciencedirect.com/science/article/pii/S2211715623002618Test; https://doaj.org/toc/2211-7156Test
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5دورية أكاديمية
المؤلفون: Laurent Larivière, Julia Eva Krüger, Thomas von Hirschheydt, Tilman Schlothauer, Katharine Bray-French, Martin Bader, Valeria Runza
المصدر: International Journal of Pharmaceutics: X, Vol 5, Iss , Pp 100157- (2023)
مصطلحات موضوعية: Antibody manufacturing process, Product-related impurities control, Functional characterization, End-to-end approach, Pharmacy and materia medica, RS1-441
وصف الملف: electronic resource
العلاقة: http://www.sciencedirect.com/science/article/pii/S2590156723000014Test; https://doaj.org/toc/2590-1567Test
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6دورية أكاديمية
المؤلفون: Hoda M. Marzouk, Nada S. Ayish, Badr A. El-Zeany, Ahmed S. Fayed
المصدر: BMC Chemistry, Vol 17, Iss 1, Pp 1-13 (2023)
مصطلحات موضوعية: HPTLC-densitometry, Capillary zone electrophoresis (CZE), Amiloride hydrochloride, Hydrochlorothiazide, Timolol maleate, Hydrochlorothiazide related impurities, Chemistry, QD1-999
وصف الملف: electronic resource
العلاقة: https://doaj.org/toc/2661-801XTest
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7دورية أكاديمية
المؤلفون: Serene W. Chen, Kong Meng Hoi, Farouq Bin Mahfut, Yuansheng Yang, Wei Zhang
المصدر: Bioresources and Bioprocessing, Vol 9, Iss 1, Pp 1-13 (2022)
مصطلحات موضوعية: Bispecific antibody, Knob-into-hole, Chromatography purification, Low-pH wash, Product-related impurities, Hole–hole homodimer, Technology, Chemical technology, TP1-1185, Biotechnology, TP248.13-248.65
وصف الملف: electronic resource
العلاقة: https://doaj.org/toc/2197-4365Test
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8دورية أكاديمية
المؤلفون: Derouicha Matmour, Nadjib Hamoum, Khalil Fateh Eddine Hassam, Yassine Merad, Nassima Hamdi Ziani
المصدر: Journal of Trace Elements and Minerals, Vol 3, Iss , Pp 100048- (2023)
مصطلحات موضوعية: Drug related impurities, Related substances, Unspecified impurities, HPLC-UV, Metronidazole, Chemistry, QD1-999
وصف الملف: electronic resource
العلاقة: http://www.sciencedirect.com/science/article/pii/S2773050623000034Test; https://doaj.org/toc/2773-0506Test
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9دورية أكاديمية
المؤلفون: Gaddam, Kishore1, 1, Kumbam, Srinivas1, Gundala, Trivikram Reddy1, Reddiwary, Surendranath Reddy1, Chinna, Gangi Reddy Nallagondu2
المصدر: Research Journal of Pharmacy and Technology 14(11):5618-5624. 2021
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10دورية أكاديمية
المؤلفون: Yu. E. Generalova, I. I. Terninko, A. B. Zelentsova, Ю. Э. Генералова, И. И. Тернинко, А. Б. Зеленцова
المساهمون: The results of the work were obtained using equipment the Сore Shared Research Facilities «Analytical Center» of the Saint Petersburg State Chemical and Pharmaceutical University, with financial support from the Ministry of Science and Higher Education of the Russian Federation (Agreement No. 075-15-2021-685, dated 26 July 2021 on the provision of the Federal budget grants)., Результаты работы получены с использованием оборудования ЦКП «Аналитический центр ФГБОУ ВО СПХФУ Минздрава России» в рамках соглашения № 075-15-2021-685 от 26 июля 2021 года при финансовой поддержке Минобрнауки России.
المصدر: Drug development & registration; Том 12, № 4 (2023); 209-216 ; Разработка и регистрация лекарственных средств; Том 12, № 4 (2023); 209-216 ; 2658-5049 ; 2305-2066
مصطلحات موضوعية: валидация, original drugs, related impurities, HPLC, validation, оригинальные ЛС, родственные примеси, ВЭЖХ
وصف الملف: application/pdf
العلاقة: https://www.pharmjournal.ru/jour/article/view/1647/1188Test; https://www.pharmjournal.ru/jour/article/downloadSuppFile/1647/1891Test; Graham J. C., Powley M. W., Udovic E., Glowienke S., Nicolette J., Parris P., Kenyon M., White A., Maisey A., Harvey J., Martin E. A., Dowdy E., Masuda-Herrera M., Trejo-Martin A., Bercu J. Calculating qualified non-mutagenic impurity levels: Harmonization of approaches. Regulatory Toxicology and Pharmacology. 2021;126:105023. DOI:10.1016/j.yrtph.2021.105023.; Vanavi P. J., Rajput S. J. Impurity profiling of first line anti-tb drug-terizidone using chromatographic and related techniques. International Journal of Pharmacy and Pharmaceutical Sciences. 2021;13(5):83–95. DOI:10.22159/ijpps.2021v13i5.40918.; Swaina D., Singh Yadava A., Sasapua C., Akulab V., Samanthula G. Debasish Swaina. UPLC Separation of forced degradation and process related impurities of Velpatasvir and structure elucidation by online LC-Quadrupole-Time of Fight-Tandem mass Spectrometry. Microchemical Journal. 2020;155:104657. DOI:10.1016/j.microc.2020.104657.; Rajana N., Devi D. R., Kumar Reddy D. N., Babu J. M., Basavaiah K., Balakumaran K. Characterization of five oxidative degradation impurities and one process impurity of suvorexant drug substance by LC-MS/MS, HR-MS and 1D, 2D NMR: validation of suvorexant drug substance and process impurities by HPLC and UPLC. Journal of Chromatographic Science. 2020;58(5):433–444. DOI:10.1093/chromsci/bmaa003; Wu P., Ye S., Li M., Li H., Kan Y., Yang Z. Impurity identification and quantification for arginine vasopressin by liquid chromatography/high-resolution mass spectrometry. Rapid Communications in Mass Spectrometry. 2020;34:e8799. DOI:10.1002/rcm.8799.; Gabriele J. W. M., Livia B. P., Camila M. B., Julia F. A. G. Determination of empagliflozin in the presence of its organic impurities and identification of two degradation products using UHPLC-QTOF/MS. Microchemical Journal. 2021;161:105795.; Huang Y., Lu H., Zhang F., Min C. Identification, isolation, characterization, and UHPLC quantification of potential genotoxic impurities in linagliptin. Journal of Separation Science. 2018;41(21):3985–3994.; Юсковец В. Н., Чернов Н. М., Яковлев И. П., Наркевич И. А. Способ получения 4,4'-(пропандиамидо)дибензоата натрия. Патент РФ на изобретение № 2624729 C1 от 21.06.2016.; Юсковец В. Н., Яковлев И. П., Наркевич И. А. Способ получения 4-[(3-этокси-3-оксопропаноил)амино]бензойной кислоты. Патент России № 2515245 C1 от 07.02.2013.; Generalova Yu., Sipkina N., Alekseeva G. Determination of related impurities in a new active pharmaceutical ingredient – Sodium 4,4'-(propanediamido)dibenzoate. Microchemical Journal. 2021;168:106498. DOI:10.1016/j.microc.2021.106498.; Миронов А. Н., Бондарев В. П. Руководство по экспертизе лекарственных средств. Т. II. М.: Гриф и К.; 2019. 280 с.; Эпштейн Н. А. Валидация аналитических методик: графические и расчетные критерии для оценки линейности методик на практике. Разработка и регистрация лекарственных средств. 2019;8(2):122–130.; https://www.pharmjournal.ru/jour/article/view/1647Test
الإتاحة: https://doi.org/10.33380/2305-2066-2023-12-4-1573Test
https://doi.org/10.1016/j.yrtph.2021.105023Test
https://doi.org/10.22159/ijpps.2021v13i5.40918Test
https://doi.org/10.1016/j.microc.2020.104657Test
https://doi.org/10.1093/chromsci/bmaa003Test
https://doi.org/10.1002/rcm.8799Test
https://doi.org/10.1016/j.microc.2021.106498Test
https://www.pharmjournal.ru/jour/article/view/1647Test