Automated solid phase extraction (SPE) LC/NMR applied to the structural analysis of extractable compounds from a pharmaceutical packaging material of construction
DL Norwood, JO Mullis, M Davis, S Pennino… - PDA Journal of …, 2013 - journal.pda.org
The structural analysis (ie, identification) of organic chemical entities leached into drug
product formulations has traditionally been accomplished with techniques involving the …
product formulations has traditionally been accomplished with techniques involving the …
7 Hyphenated techniques
DL Norwood, JO Mullis, TN Feinberg - Separation Science and Technology, 2007 - Elsevier
This chapter discusses the combination of high performance liquid chromatography (HPLC)
with compound specific detection by mass spectrometry (HPLC/MS or LC/MS), and …
with compound specific detection by mass spectrometry (HPLC/MS or LC/MS), and …
Planar chromatography coupled to mass spectrometry
KL Busch, JO Mullis, RE Carlson - Journal of Liquid …, 1993 - Taylor & Francis
Applications of thin-layer chromatography/mass spectrometry are expanding rapidly due to
commercial availability of the devices, and improved understanding of the procedures …
commercial availability of the devices, and improved understanding of the procedures …
N-nitrosamines as “special case” leachables in a metered dose inhaler drug product
DL Norwood, JO Mullis, TN Feinberg… - PDA Journal of …, 2009 - journal.pda.org
N-nitrosamines are chemical entities, some of which are considered to be possible human
carcinogens, which can be found at trace levels in some types of foods, tobacco smoke, …
carcinogens, which can be found at trace levels in some types of foods, tobacco smoke, …
Recognition of quaternary ammonium compounds using mass spectrometry
DL Fisher, M Arthur Moseley, JO Mullis… - … in mass spectrometry, 1994 - Wiley Online Library
Liquid secondary‐ion mass spectrometry (LSIMS) experiments were performed on a series
of model quaternary ammonium chlorides [M Cl − ] in order to develop a strategy, via an …
of model quaternary ammonium chlorides [M Cl − ] in order to develop a strategy, via an …
The Analytical Evaluation Threshold (AET) and its Relationship to Safety Thresholds
DL Norwood, JO Mullis… - … , Qualification, and Best …, 2012 - Wiley Online Library
The proposed safety thresholds for patient exposure to individual organic leachables in orally
inhaled and nasal drug products (OINDPs, or “inhalation drug products”), the qualification …
inhaled and nasal drug products (OINDPs, or “inhalation drug products”), the qualification …
Fluid regimes during late stages of a continental collision: Physical, chemical, and stable isotope measurements of fluid inclusions in fissure quartz from a geotraverse …
J Mullis, J Dubessy, B Poty, J O'Neil - Geochimica et cosmochimica Acta, 1994 - Elsevier
Fluid evolution during neo-alpine metamorphism during late stages of the continental collision
between Europe and Africa was studied by analyzing fluid inclusions in alpine fissure …
between Europe and Africa was studied by analyzing fluid inclusions in alpine fissure …
Analytical Techniques for Identification and Quantitation of Extractables and Leachables
DL Norwood, TN Feinberg, JO Mullis… - … , and Best Practices …, 2012 - Wiley Online Library
As detailed in earlier chapters of this volume, organic extractables and leachables can
represent a wide variety of chemical types and classes and be present in both container closure …
represent a wide variety of chemical types and classes and be present in both container closure …
Trace level impurity analysis
DL Norwood, F Qiu, JO Mullis - … of Pharmaceutical Technology …, 2006 - api.taylorfrancis.com
The issue of trace-level impurities in active pharmaceutical ingredients (APIs, also termed “Drug
Substances”) and formulations developed for APIs (termed “Drug Products”) is a broad …
Substances”) and formulations developed for APIs (termed “Drug Products”) is a broad …
Extractables: Case Study of a Sulfur‐Cured Elastomer
…, F Qiu, JR Coleman, JO Mullis… - … , and Best Practices …, 2012 - Wiley Online Library
Chapter 14 of this book addressed controlled extraction studies (CES s) in detail, including
the philosophy of designing and accomplishing CESs in the modern pharmaceutical …
the philosophy of designing and accomplishing CESs in the modern pharmaceutical …