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1.
Comparison of the Levels of Rubber Stopper-Related Organic Leachables in Commercially Available Vialed Liquid and Lyophilized Drug Products.
Pharm Res
; 37(4): 76, 2020 Mar 30.
Artículo
en Inglés
| MEDLINE | ID: mdl-32232571
2.
A Commentary on Several Study Design Considerations Pertaining to the Screening of Substances Extracted and/or Leached from Pharmaceutical Contact Materials.
PDA J Pharm Sci Technol
; 75(6): 536-552, 2021.
Artículo
en Inglés
| MEDLINE | ID: mdl-33990421
3.
Comparison of the Extraction Properties of Binary Polysorbate 80/Water and Isopropanol/Water Solutions for Organic Substances Originating from a Parenteral Infusion Pump.
PDA J Pharm Sci Technol
; 73(6): 588-614, 2019.
Artículo
en Inglés
| MEDLINE | ID: mdl-31420503
4.
Assessment of Patient Exposure to Leachables From Lyophilized Drug Formulations Following Reconstitution, Storage, and Administration via Polymeric Packaging/Delivery Systems.
J Pharm Sci
; 107(11): 2837-2846, 2018 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-30005987
5.
Establishment of a reference standard database for use in the qualitative and semi-quantitative analysis of pharmaceutical contact materials within an extractables survey by GC-MS.
J Pharm Biomed Anal
; 151: 49-60, 2018 Mar 20.
Artículo
en Inglés
| MEDLINE | ID: mdl-29306734
6.
Comparison of a Lyophilized Drug Product to Other Solid and Liquid Media for the Extraction of Elastomeric Oligomers from a Butyl Rubber Stopper.
PDA J Pharm Sci Technol
; 71(6): 488-501, 2017.
Artículo
en Inglés
| MEDLINE | ID: mdl-28928293
7.
Assessment of Extractable and Leachable Substances from Pharmaceutical Contact Materials: Where Are We and Where Do We Go from Here?
PDA J Pharm Sci Technol
; 75(1): 1-3, 2021.
Artículo
en Inglés
| MEDLINE | ID: mdl-33619224
8.
Comparison of the Solubilization Properties of Polysorbate 80 and Isopropanol/Water Solvent Systems for Organic Compounds Extracted from Three Pharmaceutical Packaging Configurations.
Eur J Pharm Sci
; 93: 475-83, 2016 Oct 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-27586022
9.
Solid phase extraction in tandem with GC/MS for the determination of semi-volatile organic substances extracted from pharmaceutical packaging/delivery systems via aqueous solvent systems.
J Pharm Biomed Anal
; 112: 126-38, 2015 Aug 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-25978495
10.
A Method Utilizing Ultra-High Performance Liquid Chromatography with Ultraviolet and Mass Spectrometric Detection for the Analysis of Material Extracts Produced during a Controlled Extraction Study.
PDA J Pharm Sci Technol
; 68(5): 504-26, 2014.
Artículo
en Inglés
| MEDLINE | ID: mdl-25336421
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