Matches in SemOpenAlex for { <https://semopenalex.org/work/W3048251145> ?p ?o ?g. }
Showing items 1 to 54 of
54
with 100 items per page.
- W3048251145 abstract "Abstract Chapters 9, 10, and 11 present general concepts of assay and impurity analysis of drug substances and drug products. Discussion of current analytical methodologies for evaluation of impurities and assay and validation of method are presented in Chapters 10 and 11 Chapter 10 Chapter 11 , along with respective calculations and concepts for analysis of samples. This chapter summarizes the general approaches to the development of acceptance criteria required for assay and impurities. The concept of qualification of impurities is presented in view of current regulatory thinking, ordinary and mutagenic impurities (presented in detail in Chapter 12 ), and impurities in clinical development, followed by case studies on different scenarios for qualification of impurities. The chapter is supplemented by Appendix 1 on the rules of rounding significant figures and use of spreadsheets and Appendix 2 on the averaging and outliers such that both have great importance in correct interpretation, presentation, and reporting of data in pharmaceutical analysis." @default.
- W3048251145 created "2020-08-13" @default.
- W3048251145 creator A5025508156 @default.
- W3048251145 creator A5037127741 @default.
- W3048251145 creator A5037491229 @default.
- W3048251145 creator A5060666331 @default.
- W3048251145 date "2020-01-01" @default.
- W3048251145 modified "2023-10-16" @default.
- W3048251145 title "Assay and impurities: specifications" @default.
- W3048251145 doi "https://doi.org/10.1016/b978-0-08-102824-7.00009-9" @default.
- W3048251145 hasPublicationYear "2020" @default.
- W3048251145 type Work @default.
- W3048251145 sameAs 3048251145 @default.
- W3048251145 citedByCount "0" @default.
- W3048251145 crossrefType "book-chapter" @default.
- W3048251145 hasAuthorship W3048251145A5025508156 @default.
- W3048251145 hasAuthorship W3048251145A5037127741 @default.
- W3048251145 hasAuthorship W3048251145A5037491229 @default.
- W3048251145 hasAuthorship W3048251145A5060666331 @default.
- W3048251145 hasConcept C127413603 @default.
- W3048251145 hasConcept C178790620 @default.
- W3048251145 hasConcept C183696295 @default.
- W3048251145 hasConcept C185592680 @default.
- W3048251145 hasConcept C199360897 @default.
- W3048251145 hasConcept C41008148 @default.
- W3048251145 hasConcept C527412718 @default.
- W3048251145 hasConcept C539667460 @default.
- W3048251145 hasConcept C71987851 @default.
- W3048251145 hasConceptScore W3048251145C127413603 @default.
- W3048251145 hasConceptScore W3048251145C178790620 @default.
- W3048251145 hasConceptScore W3048251145C183696295 @default.
- W3048251145 hasConceptScore W3048251145C185592680 @default.
- W3048251145 hasConceptScore W3048251145C199360897 @default.
- W3048251145 hasConceptScore W3048251145C41008148 @default.
- W3048251145 hasConceptScore W3048251145C527412718 @default.
- W3048251145 hasConceptScore W3048251145C539667460 @default.
- W3048251145 hasConceptScore W3048251145C71987851 @default.
- W3048251145 hasLocation W30482511451 @default.
- W3048251145 hasOpenAccess W3048251145 @default.
- W3048251145 hasPrimaryLocation W30482511451 @default.
- W3048251145 hasRelatedWork W1702080 @default.
- W3048251145 hasRelatedWork W4476502 @default.
- W3048251145 hasRelatedWork W5350381 @default.
- W3048251145 hasRelatedWork W5703791 @default.
- W3048251145 hasRelatedWork W5788774 @default.
- W3048251145 hasRelatedWork W5836922 @default.
- W3048251145 hasRelatedWork W5963193 @default.
- W3048251145 hasRelatedWork W693961 @default.
- W3048251145 hasRelatedWork W7298372 @default.
- W3048251145 hasRelatedWork W907471 @default.
- W3048251145 isParatext "false" @default.
- W3048251145 isRetracted "false" @default.
- W3048251145 magId "3048251145" @default.
- W3048251145 workType "book-chapter" @default.