Comprehensive Determination of Extractables from Five Different Brands of Stoppers Used for Injectable Products

References

1. 1.↵
   1. Nassar M. N.,
   2. Nesarikar V. V.,
   3. Lozano R.

   Degradation of a lyophilized formulation of BMS-204352: identification of degradants and role of elastomeric closures. Pharm. Dev. Technol. 2005, 10 ( 2) 227– 232.

   OpenUrlPubMedGoogle Scholar
2. 2.↵
   1. Primeau M.-N.,
   2. Adkinson N. F.,
   3. Hamilton R. G.

   Natural rubber pharmaceutical vial closures release latex allergens that produce skin reactions. J. Allergy Clin. Immunol. 2001, 107 ( 6) 958– 962.

   OpenUrlCrossRefPubMedGoogle Scholar
3. 3.↵
   1. Zhao X.,
   2. Jin S.-H.,
   3. Hu C.-Q.

   The effect of rubber closures on the haze state of ceftriaxone sodium for injection. Drug Dev. Ind. Pharm. 2007, 33 ( 1), 35– 44.

   OpenUrlPubMedGoogle Scholar
4. 4.↵
   1. Zhang F.,
   2. Chang A.,
   3. Karaisz K.,
   4. Feng R.,
   5. Cai J.

   Structural identification of extractables from rubber closures used for pre-filled semisolid drug applicator by chromatography, mass spectrometry, and organic synthesis. J. Pharm. Biomed. Anal. 2004, 34 ( 5), 841– 849.

   OpenUrlPubMedGoogle Scholar
5. 5.↵
   1. Jenke D.

   Extractable/leachable substances from plastic materials used as pharmaceutical product containers/devices. J. Pharm. Sci. Technol. 2002, 56 ( 6), 332– 371.

   OpenUrlGoogle Scholar
6. 6.↵
   1. Bennett C. L.,
   2. Luminari S.,
   3. Nissenson A. R.,
   4. Tallman M. S.,
   5. Klinge S. A.,
   6. McWilliams N.,
   7. McKoy J. M.,
   8. Kim B.,
   9. Lyons A.,
   10. Trifilio S. M.,
   11. Raisch D. W.,
   12. Evens A. M.,
   13. Kuzel T. M.,
   14. Schumock G. T.,
   15. Belknap S. M.,
   16. Locatelli F.,
   17. Rossert J.,
   18. Casadevall N.

   Pure red-cell aplasia and epoetin therapy. N. Eng. J. Med. 2004, 351 ( 14), 1403– 1408.

   OpenUrlCrossRefPubMedWeb of ScienceGoogle Scholar
7. 7.↵
   1. Zhang X. K.,
   2. Dutky R. C.,
   3. Fales H. M.

   Rubber stoppers as sources of contaminants in electrospray analysis of peptides and proteins. Anal. Chem. 1996, 68 ( 18), 3288– 3289.

   OpenUrlPubMedGoogle Scholar
8. 8.↵
   FDA Guidance for Industry. Container closure systems for packaging human drugs and biologics, CMC documentation, CDER and CBER, May 1999.

   Google Scholar
9. 9.↵
   FDA Guidance for Industry. Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products. Chemistry, Manufacturing, and Controls Documentation. http://www.fda.gov/cder/guidance/2180dft.

   Google Scholar
10. 10.↵
    FDA Guidance for Industry. Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products. Chemistry, Manufacturing, and Controls Documentation. http://www.fda.gov/cder/guidance/4234fnl.

    Google Scholar
11. 11.↵
    1. Milano C. J.,
    2. Bailey L. C.

    Evaluation of current compendial physiochemical test procedures for pharmaceutical elastomeric closures and development of an improved HPLC procedure. J. Pharm. Sci. Technol. 1999, 53 ( 4), 202– 210.

    OpenUrlGoogle Scholar
12. 12.↵
    1. DePaolis A.,
    2. Zhu L.,
    3. Gunturi S.,
    4. Deng F.,
    5. Begum S.,
    6. Tolman G.,
    7. Templeman T.,
    8. Ghobrial I.

    Rapid screening of UV absorbing leachables in biologic product placebos. Am. Pharm. Rev. 2006, 9 ( 5), 54, 56– 59.

    OpenUrlGoogle Scholar
13. 13.↵
    1. Paskiet D. M.

    Strategy for determining extractables from rubber packaging materials in drug products. J. Pharm. Sci. Technol. 1997, 51 ( 6), 248– 251.

    OpenUrlGoogle Scholar
14. 14.↵
    1. Petersen C.

    New challenges to elastomeric closures. Pharm. Ind. 2002, 64 ( 8A), 899– 907.

    OpenUrlGoogle Scholar
15. 15.↵
    1. Xiao B.,
    2. Gozo S. K.,
    3. Herz L.

    Development and validation of HPLC methods for the determination of potential extractables from elastomeric stoppers in the presence of a complex surfactant vehicle used in the preparation of parenteral drug products. J. Pharm. Biomed. Anal. 2007, 43 ( 2), 558– 565.

    OpenUrlPubMedGoogle Scholar
16. 16.↵
    1. Delaunay-Bertoncini N.,
    2. Van der Wielen F. W. M.,
    3. De Voogt P.,
    4. Erlandsson B.,
    5. Schoenmakers P. J.

    Analysis of low-molar-mass materials in commercial rubber samples by Soxhlet and headspace extractions followed by GC-MS analysis. J. Pharm. Biomed. Anal. 2004, 35 ( 5), 1059– 1073.

    OpenUrlPubMedGoogle Scholar
17. 17.↵
    1. Michulec M.,
    2. Wardencki W.

    The application of single drop extraction technique for chromatographic determination of solvent residues in edible oils and pharmaceutical products. Chromatographia 2006, 64 ( 3–4), 191– 197.

    OpenUrlGoogle Scholar
18. 18.↵
    1. Perez Pavon J. L.,
    2. del Nogal Sanchez M.,
    3. Garcia Pinto C.,
    4. Fernandez Laespada M. E.,
    5. Moreno Cordero B.

    Use of mass spectrometry methods as a strategy for detection and determination of residual solvents in pharmaceutical products. Anal. Chem. 2006, 78 ( 14), 4901– 4908.

    OpenUrlPubMedGoogle Scholar
19. 19.↵
    FDA Guidance for Industry. QC3 Impurities: residual solvents, FDA, CDER, CBER, ICH Dec. 1997.

    Google Scholar
20. 20.↵
    1. Lohmiller J. J.,
    2. Lipman N. S.

    Silicon crystals in water of autoclaved glass bottles. Contemp. Top. Lab. Anim. Sci. 1998, 37 ( 1), 62– 65.

    OpenUrlPubMedGoogle Scholar
21. 21.↵
    1. Byrne W.

    Reverse Osmosis: A Practical Guide for Industrial Users; Tall Oaks Publishing: Littleton, CO, 1995.

    Google Scholar
22. 22.↵
    1. Passl W.

    Interactions of parenteral solutions with sulphur-treated glass bottles. J. Pharm. Pharmacol. 1979, 31 ( 11), 721– 725.

    OpenUrlPubMedGoogle Scholar