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Isolation, Identification, and Characterization of an Unknown Impurity in Lovastatin EP

An unknown impurity in the fermentation-based drug substance lovastatin at 0.52 RRT was observed invariably in all batches when analyzed by HPLC as per the PhEur monograph. This impurity was isolated from the impurity-enriched sample using reversed-phase preparative HPLC and characterized by using s...

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Detalhes bibliográficos
Main Authors: Belwal, Chandrakant, Goyal, Praveen Kumar, Balte, Anup, Kolhe, Sandeep, Chauhan, Kamlesh, Rawat, Ajay Singh, Vardhan, Anand
Formato: Artigo
Idioma:Inglês
Publicado em: Österreichische Apotheker-Verlagsgesellschaft 2014
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3951232/
https://ncbi.nlm.nih.gov/pubmed/24634841
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3797/scipharm.1305-04
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