Analysis of fouling and breakthrough of process related impurities during depth filtration using confocal microscopy
Sign Up to like & getrecommendations! Published in 2022 at "Biotechnology Progress"
DOI: 10.1002/btpr.3233
Abstract: Titer improvement has driven process intensification in mAb manufacture. However, this has come with the drawback of high cell densities and associated process related impurities such as cell debris, host cell protein (HCP), and DNA.… read more here.
Keywords: related impurities; x0sp; filter; microscopy ... See more keywords
Isolation and characterization of novel process-related impurities in empagliflozin.
Sign Up to like & getrecommendations! Published in 2021 at "Journal of pharmaceutical and biomedical analysis"
DOI: 10.1016/j.jpba.2021.114001
Abstract: Empagliflozin is an effective sodium glucose cotransporter-2 (SGLT2) inhibitor to improve glycemic control in adults with type 2 diabetes. During the manufacture of empagliflozin, three unknown impurities were discovered in pilot batches ranging from 0.05… read more here.
Keywords: characterization novel; isolation characterization; novel process; related impurities ... See more keywords
Isolation, synthesis, identification of new process-related impurities in evocalcet.
Sign Up to like & getrecommendations! Published in 2022 at "Journal of pharmaceutical and biomedical analysis"
DOI: 10.1016/j.jpba.2022.114715
Abstract: Evocalcet is a calcimimetic for the treatment of secondary hyperparathyroidism. In the preparation of evocalcet, eleven process-related impurities were detected in the reaction solution of the last step at levels of 0.05%- 2.50% by a new… read more here.
Keywords: identification new; related impurities; isolation synthesis; synthesis identification ... See more keywords
Identification, characterization, and determination of process-related impurities in Minodronic Acid bulk drug
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DOI: 10.2174/1573412917666210604160621
Abstract: Minodronic acid (MA) is a third-generation nitrogen-containing heterocyclic bisphosphonate used to treat osteoporosis. In the process of starting materials research and preparation, the key intermediate impurities and degradation impurities have a great impact on the… read more here.
Keywords: impurities minodronic; minodronic acid; related impurities; acid bulk ... See more keywords
Chiral recognition of polysaccharide based CSP for separation of enantiomers and regio isomers of Prasugrel and its related impurities
Sign Up to like & getrecommendations! Published in 2017 at "journal of applied pharmaceutical science"
DOI: 10.7324/japs.2017.70732
Abstract: This study focuses on the efficiency of chiral chromatographic conditions for separation of critical enantiomers and regio-isomers of Prasugrel, an antiplatelet drug and its related impurities. Totally, 10 chiral compounds were screened and well resolved… read more here.
Keywords: related impurities; chiral recognition; regio isomers; enantiomers regio ... See more keywords