Zobrazeno 1 - 10
of 13
pro vyhledávání: '"Van D. Reif"'
Autor:
David P. Elder, Steve Eyley, Karine Jacq, Kevin L. Facchine, Pat Sandra, Ed Delaney, Rolf Schulte Oestrich, Frank David, Van D. Reif, Andrew Teasdale
Publikováno v:
Journal of Pharmaceutical Sciences. 99:2948-2961
The issue of controlling genotoxic impurities in novel active pharmaceutical ingredients (APIs) is a significant challenge. Much of the current regulatory concern, has been focused on the formation and control of genotoxic sulfonate esters. This is l
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::795e815538531bc50cdb1e68836dfc44
https://doi.org/10.1002/jps.22058
https://doi.org/10.1002/jps.22058
Autor:
Van D. Reif, Stephen C. Eyley, Andrew M. Lipczynski, Simon Golec, Pat Sandra, Kevin L. Facchine, Edward J. Delaney, David P. Elder, Rolf Schulte Oestrich, Wilfried Hoffmann, Andrew Teasdale, Karine Jacq, Karen Taylor-Worth, Frank David
Publikováno v:
Organic Process Research & Development. 14:999-1007
Sulfonate esters of lower alcohols possess the capacity to react with DNA and cause mutagenic events, which in turn may be cancer inducing. Consequently, the control of residues of such substances in products that may be ingested by man (in food or p
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8af6b7af883b282822a8ed29dbad9358
https://doi.org/10.1021/op900301n
https://doi.org/10.1021/op900301n
Autor:
Stephen C. Eyley, Rolf Schulte Oestrich, David P. Elder, Andrew Teasdale, Karen Taylor-Worth, Ed Delaney, Andrew M. Lipczynski, Frank David, Kevin L. Facchine, Patrick Sandra, Van D. Reif, Karine Jacq, Simon Golec
Publikováno v:
Organic Process Research & Development. 13:429-433
Sulfonate salts offer useful modification of physicochemical properties of active pharmaceutical ingredients (APIs) containing basic groups, but there are regulatory concerns over the presence of sulfonate esters as potential genotoxic impurities (PG
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::2d3c327caa459db72ecf8eb84632a21e
https://doi.org/10.1021/op800192a
https://doi.org/10.1021/op800192a
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 24:405-412
A simple reversed phase high performance liquid chromatographic method was developed for the analysis of isepamicin sulfate. The use of evaporative light scattering detection eliminates the need for sample derivatization. Separation of the isepamicin
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::830c8d973809dda6693453e0d7cc9476
https://doi.org/10.1016/s0731-7085(00)00465-9
https://doi.org/10.1016/s0731-7085(00)00465-9
Publikováno v:
Journal of Chromatography A. 891:115-127
SCH 201781 is a synthetic argininal peptide containing two chiral centers and an aromatic sulfonamide group. It can exist as four reversible forms, the aldehyde, the hydrate, and two diastereomeric aminals. Capillary zone electrophoresis (CZE) and re
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8b0468f3ab0ef10604bc2baba147dba0
https://doi.org/10.1016/s0021-9673(00)00621-x
https://doi.org/10.1016/s0021-9673(00)00621-x
Autor:
Andrew M. Lipczynski, Pat Sandra, Andrew Teasdale, Simon Golec, Kevin L. Facchine, Karine Jacq, Ed Delaney, Karen Taylor-Worth, Steve Eyley, Van D. Reif, Rolf Schulte Oestrich, Frank David, David P. Elder
Publikováno v:
Journal of pharmaceutical and biomedical analysis. 48(5)
An automated sample preparation and analysis procedure was developed to monitor the formation of ethyl methane sulfonate from reaction mixtures containing ethanol and methane sulfonic acid. The system is based on a liquid handling robot combined with
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cee6ebcd0cd82c42e9dd1635e28fbd4a
https://pubmed.ncbi.nlm.nih.gov/18996665
https://pubmed.ncbi.nlm.nih.gov/18996665
Autor:
Ronald L. Mueller, Brian Scarlett, William H. Doub, Frank M. Etzler, Richard N. Kelly, Sharon M. Snorek, John F. Bauer, Hullahalli R. Prasanna, Justin J. Lane, Joseph G. Stowell, Eric P. Duffy, Pascal H. Toma, Van D. Reif, Nallaperumal Chidambaram, Chetan P. Pujara
Publikováno v:
Journal of pharmaceutical sciences. 96(6)
This document provides information for the Pharmaceutical Industry and the Federal Drug Administration (FDA) regarding the selection of suitable particle-size analysis techniques, development and validation of particle-size methods, and the establish
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ba50c85b166abc421cec62d61cec81aa
https://pubmed.ncbi.nlm.nih.gov/17238204
https://pubmed.ncbi.nlm.nih.gov/17238204
Publikováno v:
Journal of Pharmaceutical Sciences. 66:1112-1116
TLC and high-pressure liquid chromatographic (HPLC) assays for folic acid were developed. In the TLC procedure, the folic acid band was extracted from the silica gel after development and determined spectrophotometrically by an oxidation and Bratton-
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6108d60c825075d34badcc1df230b87a
https://doi.org/10.1002/jps.2600660815
https://doi.org/10.1002/jps.2600660815
Autor:
Van D. Reif
Publikováno v:
Drug Development and Industrial Pharmacy. 5:447-458
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::033692fd62825710528bf6f79502a805
https://doi.org/10.3109/03639047909069233
https://doi.org/10.3109/03639047909069233
Publikováno v:
Journal of pharmaceutical sciences. 75(7)
Precise, rugged, stability-indicating HPLC assays were developed for phenobarbital, pentobarbital, and secobarbital sodium injections. Degradation products of the three barbiturates were prepared and chromatographed to demonstrate method specificity.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5f7313f9a45a257543fcf5489e5bc4f0
https://pubmed.ncbi.nlm.nih.gov/3761174
https://pubmed.ncbi.nlm.nih.gov/3761174