PT  - JOURNAL ARTICLE
AU  - Frances Degrazio
AU  - Joseph Runkle
AU  - Jeff Smythe
AU  - Amy Miller
TI  - Analysis of Biopharmaceutical Market-Appropriate Plastic Syringe Barrel for Extractables
DP  - 2009 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 360--367
VI  - 63
IP  - 4
4099  - http://journal.pda.org/content/63/4/360.short
4100  - http://journal.pda.org/content/63/4/360.full
SO  - PDA J Pharm Sci Technol2009 Jul 01; 63
AB  - A study was designed to evaluate a new syringe system developed specifically for sensitive pharmaceutical and biopharmaceutical drug products. An in-depth review of the extractables portion of this program is presented and includes data generated by liquid chromatography-mass spectroscopy, gas chromatography-mass spectroscopy, ion chromatography, and inductively coupled plasma of the Crystal Zenith® barrel before and after sterilization. One leachable was identified after e-beam irradiation processing. This leachable, identified as an organic acid species, was then evaluated from a safety assessment viewpoint. The details of this program and associated results are explained in this report.