The role of mass spectrometry and related techniques in the analysis of extractable and leachable chemicals

A multi-detector chromatographic approach for characterization and quantitation of botanical constituents to enable in silico safety assessments

(2018) Timothy R. Baker et al.   ANALYTICAL AND BIOANALYTICAL CHEMISTRY

Theoretical and Practical Considerations When Selecting Solvents for Use in Extractables Studies of Polymeric Contact Materials in Single-Use Systems Applied in the Production of Biopharmaceuticals

(2018) Samuel Dorey et al.   INDUSTRIAL & ENGINEERING CHEMISTRY RESEARCH

Qualitative assessment of extractables from single-use components and the impact of reference standard selection

(2018) Mark Anderson Jordi et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Identification, analysis and safety assessment of leachables and extractables

(2018) Dennis Jenke   TRAC-TRENDS IN ANALYTICAL CHEMISTRY

Universal response quantification approach using a Corona Charged Aerosol Detector (CAD) – Application on linear and cyclic oligomers extractable from polycondensate plastics polyesters, polyamides and polyarylsulfones

(2018) Martin Eckardt et al.   JOURNAL OF CHROMATOGRAPHY A

Multi-Detector Characterization of Grape Seed Extract to Enable in silico Safety Assessment

(2018) Vincent P. Sica et al.   Frontiers in Chemistry

In silico approach to safety of botanical dietary supplement ingredients utilizing constituent-level characterization

(2017) Jason G. Little et al.   FOOD AND CHEMICAL TOXICOLOGY

Evaluation of solvent systems for optimized extractables studies of single use bioprocessing solutions

(2017) Noemí Dorival-García et al.   JOURNAL OF CHROMATOGRAPHY A

Development and validation of an ultra-performance liquid chromatography method for the determination of bis(2,4-di- tert -butylphenyl)phosphate and related extractable compounds from single-use plastic films

(2017) Christine Ta et al.   JOURNAL OF CHROMATOGRAPHY A

Identification of UV-absorbing extractables from rubber closures used in containers of injectable powder and safety assessment of leachables in the drug

(2017) Yulei Wei et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Identification of leachables observed in the size exclusion chromatograms of a low concentration product stored in prefilled syringes

(2017) Joseph J. Valente et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

A tutorial in small molecule identification via electrospray ionization-mass spectrometry: The practical art of structural elucidation

(2017) Thomas De Vijlder et al.   MASS SPECTROMETRY REVIEWS

Detection and Identification of Leachables in Vaccine from Plastic Packaging Materials Using UPLC-QTOF MS with Self-Built Polymer Additives Library

(2016) Yun Zhang et al.   ANALYTICAL CHEMISTRY

Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics – Current challenges and approaches

(2016) Thomas H. Broschard et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Single-use in the biopharmaceutical industry: A review of current technology impact, challenges and limitations

(2015) Adriana G. Lopes   FOOD AND BIOPRODUCTS PROCESSING

Extractables and leachables issues with the application of single use technology in the biopharmaceutical industry

(2015) Ying Gao et al.   JOURNAL OF CHEMICAL TECHNOLOGY AND BIOTECHNOLOGY

Determination of plastic additives in packaging by liquid chromatography coupled to high resolution mass spectrometry

(2015) Cristina Moreta et al.   JOURNAL OF CHROMATOGRAPHY A

Controlled Extraction Studies Applied to Polyvinyl Chloride and Polyethylene Materials: Conclusions from the ELSIE Controlled Extraction Pilot Study

(2014) Andrew Teasdale et al.   AAPS PHARMSCITECH

A cytotoxic leachable compound from single-use bioprocess equipment that causes poor cell growth performance

(2014) Matthew Hammond et al.   BIOTECHNOLOGY PROGRESS

Development and application of a non-targeted extraction method for the analysis of migrating compounds from plastic baby bottles by GC-MS

(2014) Matthias Onghena et al.   Food Additives and Contaminants Part A-Chemistry Analysis Control Exposure & Risk Assessment

Ambient analysis of leachable compounds from single-use bioreactors with desorption electrospray ionization time-of-flight mass spectrometry

(2014) Jian Liu et al.   RAPID COMMUNICATIONS IN MASS SPECTROMETRY

Rapid identification of polymer additives by atmospheric solid analysis probe with quadrupole time-of-flight mass spectrometry

(2014) Zhenxia Du et al.   RAPID COMMUNICATIONS IN MASS SPECTROMETRY

Monitoring the extraction of additives and additive degradation products from polymer packaging into solutions by multi-residue method including solid phase extraction and ultra-high performance liquid chromatography-tandem mass spectrometry analysis

(2013) Charlène Pouech et al.   ANALYTICAL AND BIOANALYTICAL CHEMISTRY

Direct Monitoring of the Role Played by a Stabilizer in a Solid Sample of Polymer Using Direct Analysis in Real Time Mass Spectrometry: The Case of Irgafos 168 in Polyethylene

(2012) Kevin Fouyer et al.   ANALYTICAL CHEMISTRY

Utilization of Internal Standard Response Factors to Estimate the Concentration of Organic Compounds Leached from Pharmaceutical Packaging Systems and Application of Such Estimated Concentrations to Safety Assessment

(2012) D. Jenke et al.   JOURNAL OF CHROMATOGRAPHIC SCIENCE

Charged aerosol detection in pharmaceutical analysis

(2012) Stefan Almeling et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

A critical review on the use of modern sophisticated hyphenated tools in the characterization of impurities and degradation products

(2012) Saranjit Singh et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Terminology for biorelated polymers and applications (IUPAC Recommendations 2012)

(2012) Michel Vert et al.   PURE AND APPLIED CHEMISTRY

Rapid identification and semi-quantitative determination of polymer additives by desorption electrospray ionization/time-of-flight mass spectrometry

(2010) Silke M. Reiter et al.   ANALYTICAL AND BIOANALYTICAL CHEMISTRY

Universal response model for a corona charged aerosol detector

(2010) Joseph P. Hutchinson et al.   JOURNAL OF CHROMATOGRAPHY A

Comparison between evaporative light scattering detection and charged aerosol detection for the analysis of saikosaponins

(2010) Han Young Eom et al.   JOURNAL OF CHROMATOGRAPHY A

Review of operating principle and applications of the charged aerosol detector

(2010) Tanja Vehovec et al.   JOURNAL OF CHROMATOGRAPHY A

Leachables from Saline-Containing IV Bags Can Alter Therapeutic Protein Properties

(2010) Judy Y. Chang et al.   PHARMACEUTICAL RESEARCH

Rapid identification of stabilisers in polypropylene using time-of-flight mass spectrometry and DART as ion source

(2009) Manuela Haunschmidt et al.   ANALYST

Migration of bisphenol A from plastic baby bottles, baby bottle liners and reusable polycarbonate drinking bottles

(2009) C. Kubwabo et al.   Food Additives and Contaminants Part A-Chemistry Analysis Control Exposure & Risk Assessment

HPLC and LC/MS Analysis of Pharmaceutical Container Closure System Leachables and Extractables

(2009) Daniel L. Norwood et al.   JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES

On Developing a Process for Conducting Extractable–Leachable Assessment of Components Used for Storage of Biopharmaceuticals

(2009) Aditya A. Wakankar et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products: An Overview of the PQRI Recommendations

(2008) Daniel L. Norwood et al.   PHARMACEUTICAL RESEARCH