Extractables/leachables from plastic tubing used in product manufacturing

International Journal of Pharmaceutics

Volumn 315, Issue 1-2, 2006, Pages 75-92

  Jenke, Dennis R ^a   Story, James ^a   Lalani, Rukhsana ^a  

^a BAXTER HEALTHCARE CORPORATION   (United States)

Author keywords

Extractables; Leachables; Plastic processing materials; Tubing

Indexed keywords

ADIPIC ACID; ANTIOXIDANT; BORON; CALCIUM; ELASTOMER; MAGNESIUM; OLIGOMER; ORGANIC CARBON; PHENOL DERIVATIVE; PHTHALIC ACID; PHTHALIC ACID DIOCTYL ESTER; PLASTIC; POLYMER; RUBBER; SILICONE; STABILIZING AGENT; ZINC;

ARTICLE; CHEMICAL ANALYSIS; CONTAINER; DECOMPOSITION; DRUG CONTAMINATION; DRUG MANUFACTURE; DRUG PACKAGING; DRUG STORAGE; DYNAMICS; FILTER; FLOW KINETICS; LEACHING; MATERIALS; PRIORITY JOURNAL; SEPARATION TECHNIQUE; SIMULATION; TARGET VARIABLE; TUBE;

DRUG CONTAMINATION; DRUG INDUSTRY; METALS; ORGANIC CHEMICALS; PLASTICS; SILICONES;

EID: 33646373432     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2006.02.011     Document Type: Article

References (15)

1. Arbin A., Jacobsson S., Hanninen K., Hagman A., and Ostelius J. Studies on the contamination of intravenous solutions from PVC-bags with dynamic headspace GC-MS and LC-diode array techniques. Int. J. Pharm. 28 (1986) 211-218
2. Berg B.E., Hegna N., Orlien N., and Greibrokk T. Determination of low levels of polymer additives migrating from polypropylene to food simulated liquids by capillary SFC and solvent venting injection. Chromatographia 37 (1993) 271-276
3. Cruz L., Jenke M., Kenley R., Chen M., and Jenke D. Influence of solute degradation on the accumulation of solutes migrating into solution from polymeric parenteral containers. Pharm. Res. 7 (1990) 967-972
4. Danielson D.M., Oxborrow G.S., and Placencia A.M. Chemical leaching of rubber stoppers into parenteral solutions. J. Parent. Sci. Technol. 37 (1983) 89-92
5. Goydan R., Schwope A.D., Redi R.C., and Cramer G. High-temperature migration of anti-oxidants from polyolefins. Food Additiv. Contam. 7 (1990) 323-337
6. Haider N., and Karlsson S. Loss and transformation products of the aromatic antioxidants in MDPE film under long-term exposure to biotic and abiotic conditions. J. Appl. Poly. Sci. 85 (2002) 974-988
7. Jenke D., Poss M., Story J., Odufu A., Zietlow D., and Tsilipetros T. Development and validation of liquid chromatographic methods for the identification and quantitation of organic compounds extracted from a polyolefin container material. J. Chromatogr. Sci. 42 (2004) 388-395
8. Jenke D. Extractable/leachable substances from plastic materials used as pharmaceutical product containers/devices. PDA J. Pharm. Sci. Technol. 56 (2002) 332-371
9. Kim-Kang H., and Gilbert S.G. Isolation and identification of potential migrants in gamma-irradiated and non-irradiated plastic laminates for unit dose injection device. Appl. Spectrosc. 45 (1991) 572-580
10. Kim H., Gilbert S.G., and Johnson J.B. Determination of potential migrants from commercial amber polyethylene terephthalate bottle wall. Pharm. Res. 7 (1990) 176-179
11. Reif A.W., Solkner P., and Rupp J. Analysis and evaluation of filter cartridge extracatables for validation in pharmaceutical downstream processing. PDA J. Pharm. Sci. Technol. 50 (1996) 399-410
12. Sarbach C., Yagoubi N., Sauzieres J., Renaux C., Ferrier D., and Postaire E. Migration of impurities from a multi-layer plastic container into a parenteral infusion solution. Int. J. Pharm. 140 (1996) 169-174
13. Snell R.P. Solid phase extraction and liquid chromatographic determination of monophthalates and phthalide extracted from solution administration sets. JAOAC 76 (1993) 531-534
14. Ulsaker G.A., and Hoem R.M. Determination by gas chromatography-single-ion monitoring mass spectrometry of phthalate contaiminants in intravenous solutions stored in PVC containers. Analyst 103 (1978) 1080-1085
15. Yu K., Block E., and Balogh M. LC-MS analysis of polymer additives by electron and atmospheric-pressure ionization: identification and quantification. LG-GC 18 (2000) 162, 164, 166, 168, 170, 172, 176, 178.