The Model Stream Approach: Defining the Worst-Case Conditions

Pharmaceutical Technology

Volumn 20, Issue 2, 1996, Pages 34-51

  Stone, Thomas E ^a   Goel, Vinay ^a   Leszczak, Jackie ^b   Chrai, Suggy ^b,c  

^a MILLIPORE CORPORATION   (United States)

^b Liposome Company Incorporated   (United States)

^c Liposome Company ^*

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0003091595     PISSN: 01478087     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (13)

1. T. Stone et al., "Methodology for Analysis of Filter Extractables: A Model Stream Approach," Pharm. Technol. 18 (10), 116-130 (1994).
2. D.R. Jenke et al., "Influence of Solute Degradation on the Accumulation of Solutes Migrating into Solution from Polymeric Parenteral Containers," Pharm. Res. 7 (9), 967-972 (1990).
3. D.S. Hayward and D.R. Jenke, "Interactions between Polymer Containers and Parenteral Solutions: Correlating Equilibrium Polymer-Water Interaction Constants with Solute Partition Coefficients," Int. J. Pharm. 66, 87-96 (1990).
4. P.P. DeLuca et al., "The Application of Proposed Procedures for Testing for Extractables in Plastic Containers," J. Paren. Sci. Technol. 36 (1), 28-34 (1982).
5. Y.J. Wang and Y.W. Chien, "Sterile Pharmaceutical Packaging, Compatibility and Stability," Parentera! Drug Association, Technical Report No. 5, 1984.
6. J.B. Boyett and K.E. Avis, "Extraction Rates of Marker Compounds from Rubber Closures for Parenteral Use," Bulletin of the Parenteral Drug Association 29 (1), 1-17 (1975).
7. "Extractables from Elastomeric Closures: Analytical Procedures for Functional Group Characterization and Identification," Parenteral Drug Association, Technical Methods Bulletin No. 1, 1980.
8. C.E. Wells et al., "Contaminants Leached from Rubber Stoppers into a Water Soluble Vitamin E Intravenous Injectable Product," J. Pharm. Sci. 75 (7), 724-725 (1986).
9. J. Autian, "Interaction between Medicaments and Plastics," J. Mond. Pharm. 4, 276-288 (1966).
10. D.R. Jenke et al., "Accumulation Model for Solutes Leaching from Polymeric Containers," J. Paren. Sci. Tech. 47, 172-176 (1993).
11. L.D Butler et al., "Effect of Inline Filtration on the Potency of Low-Dose Drugs," Am. J. Hosp. Pharmacy 37 (July), 935-941 (1980).
12. R.A. Kenley et al., "Determination of Solute-Polymer Interaction Properties and Their Application to Parenteral Product Container Compatibility Evaluations," Pharm. Res. 7 (9), 911-918 (1990).
13. T. Stone, unpublished correspondence, 1995.