A method utilizing ultra-high performance liquid chromatography with ultraviolet and mass spectrometric detection for the analysis of material extracts produced during …

SA Zdravkovic, MD Bruss, RF Piccoli… - PDA Journal of …, 2014 - journal.pda.org
Pharmaceutical packaging/delivery systems and medical devices are characterized via a
controlled extraction study as part of the development process for new pharmaceutical …

Solid phase extraction in tandem with GC/MS for the determination of semi-volatile organic substances extracted from pharmaceutical packaging/delivery systems via …

SA Zdravkovic - Journal of pharmaceutical and biomedical analysis, 2015 - Elsevier
An extractable survey is one of several studies performed on a pharmaceutical
storage/delivery system as part of the process of demonstrating that the system is suitable for …

Analysis and evaluation of single-use bag extractables for validation in biopharmaceutical applications

I Pahl, S Dorey, M Barbaroux, B Lagrange… - PDA Journal of …, 2014 - journal.pda.org
This paper describes an approach of extractables determination and gives information on
extractables profiles for gamma-sterilized single-use bags with polyethylene inner contact …

Non-volatile extractable analysis of prefilled syringes for parenteral administration of drug products

N Dorival-García, I Larsson, J Bones - Journal of Pharmaceutical and …, 2017 - Elsevier
The determination of extractable profiles for single-use technologies represents an important
aspect of pharmaceutical production to minimize any possible compromise in drug product …

Controlled extraction studies applied to polyvinyl chloride and polyethylene materials: conclusions from the ELSIE controlled extraction pilot study

A Teasdale, M Jahn, S Bailey, A Feilden, G Taylor… - AAPS …, 2015 - Springer
The effective management of leachables in pharmaceutical products is a critical aspect of
their development. This can be facilitated if extractables information on the materials used in …

Extractables characterization for five materials of construction representative of packaging systems used for parenteral and ophthalmic drug products

D Jenke, J Castner, T Egert, T Feinberg… - PDA Journal of …, 2013 - journal.pda.org
Polymeric and elastomeric materials are commonly encountered in medical devices and
packaging systems used to manufacture, store, deliver, and/or administer drug products …

Extractables analysis of single-use flexible plastic biocontainers

L Marghitoiu, J Liu, H Lee, L Perez… - PDA Journal of …, 2015 - journal.pda.org
Studies of the extractable profiles of bioprocessing components have become an integral
part of drug development efforts to minimize possible compromise in process performance …

Sample preparation methods for the analysis of pharmaceutical materials

DT Rossi, KG Miller - Separation Science and Technology, 2004 - Elsevier
This chapter provides practical guidance on the use of six widely used extraction and
isolation techniques from the sample preparation perspective. The first two sections, solid …

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 …

How sterilization of primary packaging influences the results of E&L studies: as the demands that are being placed on the quality and stability of medications continue …

T Sogding, D Canton, D Haines, U Rothhaar - Contract Pharma, 2015 - go.gale.com
Even primary packaging that has been manufactured and stored properly can release
substances into the drug formulation. For this reason, pharmaceutical manufacturers are …