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

Steven A. Zdravkovic; Matthew D. Bruss; Robert F. Piccoli; Derek M. Wood

doi:10.5731/pdajpst.2014.00992

References

1.↵
Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics. U.S. Department of Health and Human Services, Food and Drug Administration: Rockville, MD, May 1999.
2.↵
Guideline on Plastic Immediate Packaging Materials. European Medicines Agency; CPMP/QWWP/4359/03. EMEA/CVMP/205/04. 19 May 2005.
3.↵
1. Yu X.,
2. Zdravkovic S.,
3. Wood D.,
4. Li C.,
5. Cheng Y.,
6. Ding Y. X.
A new approach to threshold evaluation and quantitation of unknown extractables and leachables using HPLC/CAD. Drug Deliv. Technol. 2009, 9 (3), 50–55.
OpenUrl
4.↵
1. Jenke D.
Compatibility of Pharmaceutical Products and Contact Materials; John Wiley and Sons, Inc.: Hoboken, NJ, 2009.
5.↵
1. Snyder L. R.,
2. Kirkland J. J.,
3. Glajch J. L.
Practical HPLC Method Development, 2nd ed.; John Wiley & Sons, Inc.: Hoboken, NJ, 1997.
6.↵
PQRI Leachables and Extractables Working Group. Safety Thresholds and Best Practices for Extractables and Lechables in Orally Inhaled and Nasal Drug Products, PQRI: Arlington, VA, 2006.
7.↵
1. Ball D. J.,
2. Norwood D. L.,
3. Stults C. L. M.,
4. Nagano L. M.
, Eds. Extractables and Leachables Handbook: Safety Evaluation and Best Practices Applied to Inhalation Drug Products. John Wiley & Sons, Inc.: Hoboken, NJ, 2012.
8.↵
1. Norwood D. L.,
2. Jenke D.,
3. Manolescu C.,
4. Pennino S.,
5. Grinberg N.
HPLC and LC/MS Analysis of pharmaceutical container closure system leachables and extractables. J. Liq. Chromatogr. 2009, 32 (11-12), 1768–1827.
OpenUrl
9.↵
1. Fichtner S.,
2. Giese U.,
3. Pahl I.,
4. Reif O. W.
Determination of “extractables” on polymer materials by means of HPLC-MS. PDA J. Pharm. Sci. Technol. 2006, 60 (5), 291–301.
OpenUrl Abstract/FREE Full Text
10.↵
1. Jenke D.,
2. Castner J.,
3. Egert T.,
4. Feinberg T.,
5. Hendricker A.,
6. Houston C.,
7. Hunt D. G.,
8. Lynch M.,
9. Shaw A.,
10. Nicholas K.,
11. Norwood D. L.,
12. Paskiet D.,
13. Ruberto M.,
14. Smith E. J.,
15. Holcomb F.
Extractables characterization for five materials of construction representative of packaging systems used for parenteral and ophthalmic drug products. PDA J. Pharm. Sci. Technol. 2013, 67 (5), 448–511.
OpenUrl Abstract/FREE Full Text
11.↵
1. Wu T.,
2. Wang C.,
3. Wang X.,
4. Xiao H.,
5. Ma Q.,
6. Zhang Q.
Comparison of UPLC and HPLC for analysis of 12 phthalates. Chromatographia 2008, 68 (9-10), 803–806.
OpenUrl CrossRef Web of Science
12.↵
1. McLaffery F. W.,
2. Tureček F.
Interpretation of Mass Spectra, 4th ed.; University Science Books: Sausalito, CA, 1993.
13.↵
1. Duderstadt R. E.,
2. Fischer S. M.
Effect of organic mobile phase composition on signal responses for selected polyalkene additive compounds by liquid chromatography–mass spectrometry. J. Chromatogr., A 2008, 1193 (1-2), 70–78.
OpenUrl PubMed
14.
1. Pereira L.
Mobile phase selection in LC/API-MS. Application Note AN04–01. Thermo Electron Corporation, 2004.
15.↵
1. Watson J. T.,
2. Sparkman O. D.
Introduction to Mass Spectrometry—Instrumentation, Applications and Strategies for Data Interpretation, 4th ed.; John Wiley and Sons, Ltd.: Chichester, UK, 2007.
16.↵
1. Hua Y.,
2. Jenke D.
Increasing the sensitivity of an LC-MS method for screening material extracts for organic extractables via mobile phase optimization. J. Chromatogr. Sci. 2012, 50 (3), 213–227.
OpenUrl Abstract/FREE Full Text
17.↵
1. Jenke D.,
2. Odufu A.
Utilization of internal standard response factors to estimate the concentrations of organic compounds leached from pharmaceutical packaging systems and application of such estimated concentrations to safety assessment. J. Chrom. Sci., 2012, 50 (3), 206–212.
OpenUrl Abstract/FREE Full Text
18.↵
1. Mullis J. O.,
2. Granger A.,
3. Quin C.,
4. Norwood D. L.
The Analytical Evaluation Threshold (AET) Concept, Sensitivity and Analytical Uncertainty. Conference Proceedings: Leachables and Extractables 2008 Smithers-Rapra; Dublin, Ireland, March 2008.
19.↵
1. Jenke D.
Extractable/leachable substances from plastic materials used as pharmaceutical product containers/devices. PDA J. Pharm. Sci. Technol. 2002, 56 (6), 332–371.
OpenUrl Abstract/FREE Full Text
20.
1. Bolgar M.,
2. Hubball J.,
3. Groeger J.,
4. Meronek S.
Handbook for the Chemical Analysis of Plastic and Polymer Additives; CRC Press: Boca Raton, FL, 2008.
21.↵
1. Murphy J.
Additives for Plastics Handbook, 2nd ed.; Elsevier Science, Inc.: New York, 2001.
22.↵
1. Norwood D. L.,
2. Mullis J. O.,
3. Davis M.,
4. Pennino S.,
5. Egert T.,
6. Gonnella N. C.
Automated solid phase extraction (SPE) LC/NMR applied to the structural analysis of extractable compounds from a pharmaceutical packaging material of construction. PDA J. Pharm. Sci. Technol. 2013, 67 (3), 267–287.
OpenUrl Abstract/FREE Full Text
23.↵
1. Loschner D.,
2. Rapp T.,
3. Schlosser F.,
4. Schuster R.,
5. Stottmeister E.,
6. Zander S.
Experience with the application of the draft European Standard prEN 15768 to the identification of leachable organic substances from materials in contact with drinking water by GC-MS. Anal. Methods 2011, 3, 2547–2556.
OpenUrl
24.↵
1. Jenke D. R.
Linking extractables and leachables in container/closure applications. PDA J. Pharm. Sci. Technol. 2005, 59 (4), 265–281.
OpenUrl Abstract/FREE Full Text
25.↵
1. Smith R. M.
Understanding Mass Spectra: A Basic Approach, 2nd ed.; John Wiley and Sons, Inc.: Hoboken, NJ, 2004.
26.↵
1. Sekimoto K.,
2. Sakai M.,
3. Takayama M.
Specific interaction between negative atmospheric ions and organic compounds in atmospheric pressure corona discharge ionization mass spectrometry. J. Am. Soc. Mass Spectrom. 2012, 23 (6), 1109–1119.
OpenUrl PubMed
27.↵
1. Jeilani Y. A.,
2. Cardelino B. H.,
3. Ibeanusi V. M.
Positive chemical ionization triple-quadrupole mass spectrometry and ab initio computational studies of the multi-pathway fragmentation of phthalates. J. Mass Spectrom. 2010, 45 (6), 678–685.
OpenUrl PubMed

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The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor Variation

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Keywords

[1] 1.↵
Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics. U.S. Department of Health and Human Services, Food and Drug Administration: Rockville, MD, May 1999.

[2] 2.↵
Guideline on Plastic Immediate Packaging Materials. European Medicines Agency; CPMP/QWWP/4359/03. EMEA/CVMP/205/04. 19 May 2005.

[3] 3.↵
Yu X.,
Zdravkovic S.,
Wood D.,
Li C.,
Cheng Y.,
Ding Y. X.
A new approach to threshold evaluation and quantitation of unknown extractables and leachables using HPLC/CAD. Drug Deliv. Technol. 2009, 9 (3), 50–55.
OpenUrl

[4] Yu X.,

[5] Zdravkovic S.,

[6] Wood D.,

[7] Li C.,

[8] Cheng Y.,

[9] Ding Y. X.

[10] 4.↵
Jenke D.
Compatibility of Pharmaceutical Products and Contact Materials; John Wiley and Sons, Inc.: Hoboken, NJ, 2009.

[11] Jenke D.

[12] 5.↵
Snyder L. R.,
Kirkland J. J.,
Glajch J. L.
Practical HPLC Method Development, 2nd ed.; John Wiley & Sons, Inc.: Hoboken, NJ, 1997.

[13] Snyder L. R.,

[14] Kirkland J. J.,

[15] Glajch J. L.

[16] 6.↵
PQRI Leachables and Extractables Working Group. Safety Thresholds and Best Practices for Extractables and Lechables in Orally Inhaled and Nasal Drug Products, PQRI: Arlington, VA, 2006.

[17] 7.↵
Ball D. J.,
Norwood D. L.,
Stults C. L. M.,
Nagano L. M.
, Eds. Extractables and Leachables Handbook: Safety Evaluation and Best Practices Applied to Inhalation Drug Products. John Wiley & Sons, Inc.: Hoboken, NJ, 2012.

[18] Ball D. J.,

[19] Norwood D. L.,

[20] Stults C. L. M.,

[21] Nagano L. M.

[22] 8.↵
Norwood D. L.,
Jenke D.,
Manolescu C.,
Pennino S.,
Grinberg N.
HPLC and LC/MS Analysis of pharmaceutical container closure system leachables and extractables. J. Liq. Chromatogr. 2009, 32 (11-12), 1768–1827.
OpenUrl

[23] Norwood D. L.,

[24] Jenke D.,

[25] Manolescu C.,

[26] Pennino S.,

[27] Grinberg N.

[28] 9.↵
Fichtner S.,
Giese U.,
Pahl I.,
Reif O. W.
Determination of “extractables” on polymer materials by means of HPLC-MS. PDA J. Pharm. Sci. Technol. 2006, 60 (5), 291–301.
OpenUrl Abstract/FREE Full Text

[29] Fichtner S.,

[30] Giese U.,

[31] Pahl I.,

[32] Reif O. W.

[33] 10.↵
Jenke D.,
Castner J.,
Egert T.,
Feinberg T.,
Hendricker A.,
Houston C.,
Hunt D. G.,
Lynch M.,
Shaw A.,
Nicholas K.,
Norwood D. L.,
Paskiet D.,
Ruberto M.,
Smith E. J.,
Holcomb F.
Extractables characterization for five materials of construction representative of packaging systems used for parenteral and ophthalmic drug products. PDA J. Pharm. Sci. Technol. 2013, 67 (5), 448–511.
OpenUrl Abstract/FREE Full Text

[34] Jenke D.,

[35] Castner J.,

[36] Egert T.,

[37] Feinberg T.,

[38] Hendricker A.,

[39] Houston C.,

[40] Hunt D. G.,

[41] Lynch M.,

[42] Shaw A.,

[43] Nicholas K.,

[44] Norwood D. L.,

[45] Paskiet D.,

[46] Ruberto M.,

[47] Smith E. J.,

[48] Holcomb F.

[49] 11.↵
Wu T.,
Wang C.,
Wang X.,
Xiao H.,
Ma Q.,
Zhang Q.
Comparison of UPLC and HPLC for analysis of 12 phthalates. Chromatographia 2008, 68 (9-10), 803–806.
OpenUrl CrossRef Web of Science

[50] Wu T.,

[51] Wang C.,

[52] Wang X.,

[53] Xiao H.,

[54] Ma Q.,

[55] Zhang Q.

[56] 12.↵
McLaffery F. W.,
Tureček F.
Interpretation of Mass Spectra, 4th ed.; University Science Books: Sausalito, CA, 1993.

[57] McLaffery F. W.,

[58] Tureček F.

[59] 13.↵
Duderstadt R. E.,
Fischer S. M.
Effect of organic mobile phase composition on signal responses for selected polyalkene additive compounds by liquid chromatography–mass spectrometry. J. Chromatogr., A 2008, 1193 (1-2), 70–78.
OpenUrl PubMed

[60] Duderstadt R. E.,

[61] Fischer S. M.

[62] 14.
Pereira L.
Mobile phase selection in LC/API-MS. Application Note AN04–01. Thermo Electron Corporation, 2004.

[63] Pereira L.

[64] 15.↵
Watson J. T.,
Sparkman O. D.
Introduction to Mass Spectrometry—Instrumentation, Applications and Strategies for Data Interpretation, 4th ed.; John Wiley and Sons, Ltd.: Chichester, UK, 2007.

[65] Watson J. T.,

[66] Sparkman O. D.

[67] 16.↵
Hua Y.,
Jenke D.
Increasing the sensitivity of an LC-MS method for screening material extracts for organic extractables via mobile phase optimization. J. Chromatogr. Sci. 2012, 50 (3), 213–227.
OpenUrl Abstract/FREE Full Text

[68] Hua Y.,

[69] Jenke D.

[70] 17.↵
Jenke D.,
Odufu A.
Utilization of internal standard response factors to estimate the concentrations of organic compounds leached from pharmaceutical packaging systems and application of such estimated concentrations to safety assessment. J. Chrom. Sci., 2012, 50 (3), 206–212.
OpenUrl Abstract/FREE Full Text

[71] Jenke D.,

[72] Odufu A.

[73] 18.↵
Mullis J. O.,
Granger A.,
Quin C.,
Norwood D. L.
The Analytical Evaluation Threshold (AET) Concept, Sensitivity and Analytical Uncertainty. Conference Proceedings: Leachables and Extractables 2008 Smithers-Rapra; Dublin, Ireland, March 2008.

[74] Mullis J. O.,

[75] Granger A.,

[76] Quin C.,

[77] Norwood D. L.

[78] 19.↵
Jenke D.
Extractable/leachable substances from plastic materials used as pharmaceutical product containers/devices. PDA J. Pharm. Sci. Technol. 2002, 56 (6), 332–371.
OpenUrl Abstract/FREE Full Text

[79] Jenke D.

[80] 20.
Bolgar M.,
Hubball J.,
Groeger J.,
Meronek S.
Handbook for the Chemical Analysis of Plastic and Polymer Additives; CRC Press: Boca Raton, FL, 2008.

[81] Bolgar M.,

[82] Hubball J.,

[83] Groeger J.,

[84] Meronek S.

[85] 21.↵
Murphy J.
Additives for Plastics Handbook, 2nd ed.; Elsevier Science, Inc.: New York, 2001.

[86] Murphy J.

[87] 22.↵
Norwood D. L.,
Mullis J. O.,
Davis M.,
Pennino S.,
Egert T.,
Gonnella N. C.
Automated solid phase extraction (SPE) LC/NMR applied to the structural analysis of extractable compounds from a pharmaceutical packaging material of construction. PDA J. Pharm. Sci. Technol. 2013, 67 (3), 267–287.
OpenUrl Abstract/FREE Full Text

[88] Norwood D. L.,

[89] Mullis J. O.,

[90] Davis M.,

[91] Pennino S.,

[92] Egert T.,

[93] Gonnella N. C.

[94] 23.↵
Loschner D.,
Rapp T.,
Schlosser F.,
Schuster R.,
Stottmeister E.,
Zander S.
Experience with the application of the draft European Standard prEN 15768 to the identification of leachable organic substances from materials in contact with drinking water by GC-MS. Anal. Methods 2011, 3, 2547–2556.
OpenUrl

[95] Loschner D.,

[96] Rapp T.,

[97] Schlosser F.,

[98] Schuster R.,

[99] Stottmeister E.,

[100] Zander S.

[101] 24.↵
Jenke D. R.
Linking extractables and leachables in container/closure applications. PDA J. Pharm. Sci. Technol. 2005, 59 (4), 265–281.
OpenUrl Abstract/FREE Full Text

[102] Jenke D. R.

[103] 25.↵
Smith R. M.
Understanding Mass Spectra: A Basic Approach, 2nd ed.; John Wiley and Sons, Inc.: Hoboken, NJ, 2004.

[104] Smith R. M.

[105] 26.↵
Sekimoto K.,
Sakai M.,
Takayama M.
Specific interaction between negative atmospheric ions and organic compounds in atmospheric pressure corona discharge ionization mass spectrometry. J. Am. Soc. Mass Spectrom. 2012, 23 (6), 1109–1119.
OpenUrl PubMed

[106] Sekimoto K.,

[107] Sakai M.,

[108] Takayama M.

[109] 27.↵
Jeilani Y. A.,
Cardelino B. H.,
Ibeanusi V. M.
Positive chemical ionization triple-quadrupole mass spectrometry and ab initio computational studies of the multi-pathway fragmentation of phthalates. J. Mass Spectrom. 2010, 45 (6), 678–685.
OpenUrl PubMed

[110] Jeilani Y. A.,

[111] Cardelino B. H.,

[112] Ibeanusi V. M.

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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

References

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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

References

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Author/Reviewer Information

Parenteral Drug Association, Inc.