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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleTechnology/Application

Validation of a Spectral Method for Quantitative Measurement of Color in Protein Drug Solutions

Jian Yin, Trevor E. Swartz, Jian Zhang, Thomas W. Patapoff, Bartolo Chen, Joseph Marhoul, Norman Shih, Bruce Kabakoff and Kimia Rahimi
PDA Journal of Pharmaceutical Science and Technology July 2016, 70 (4) 382-391; DOI: https://doi.org/10.5731/pdajpst.2016.006494
Jian Yin
1Early Stage Pharmaceutical Development Department,
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  • For correspondence: Yin.Jian@gene.com
Trevor E. Swartz
1Early Stage Pharmaceutical Development Department,
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Jian Zhang
2Analytical Development and Quality Control Department, and
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Thomas W. Patapoff
1Early Stage Pharmaceutical Development Department,
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Bartolo Chen
2Analytical Development and Quality Control Department, and
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Joseph Marhoul
3Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA
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Norman Shih
1Early Stage Pharmaceutical Development Department,
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Bruce Kabakoff
1Early Stage Pharmaceutical Development Department,
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Kimia Rahimi
2Analytical Development and Quality Control Department, and
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  • Article
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References

  1. 1.↵
    U.S. Food and Drug Administration. Guidance for Industry, Q6B Specifications. International Conference on Harmonisation (ICH). Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, 1999.
  2. 2.↵
    European Pharmacopoeia Commission. European Pharmacopoeia, Version 8; Council of Europe: Strasbourg, France, 2014; p v.
  3. 3.↵
    1. Swartz T. E,
    2. Yin J.,
    3. Patapoff T.,
    4. Horst T.,
    5. Skieresz S. M.,
    6. Leggett G.,
    7. Morgan C. J.,
    8. Rahimi K.,
    9. Marhoul J.,
    10. Kabakoff B.
    A Spectral Method for Color Quantitation of a Protein Drug Solution. PDA J. Pharm. Sci. Technol. 2016, 70 (4), 361–381.
    OpenUrlAbstract/FREE Full Text
  4. 4.↵
    ICH Harmonized Tripartite Guideline: Validation of Analytical Procedures: Text and Methadology Q2(R1). In International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, version 4, 1994.
  5. 5.↵
    ASTM International. ASTM E308-08: Standard Practice for Computing the Colors of Objects by Using the CIE System, 2008.
  6. 6.↵
    1. Luo M. R.,
    2. Cui G.,
    3. Rigg B.
    The Development of the CIE 2000 Colour-Difference Formula: CIEDE2000. Color Res. Appl. 2001, 26 (5), 340–350.
    OpenUrlCrossRef
  7. 7.↵
    1. Shevell S. K.
    The Science of Color, 2nd ed.; Optical Society of America; Elsevier: Amsterdam, Boston, 2003; p ix.
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PDA Journal of Pharmaceutical Science and Technology: 70 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 4
July/August 2016
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Validation of a Spectral Method for Quantitative Measurement of Color in Protein Drug Solutions
Jian Yin, Trevor E. Swartz, Jian Zhang, Thomas W. Patapoff, Bartolo Chen, Joseph Marhoul, Norman Shih, Bruce Kabakoff, Kimia Rahimi
PDA Journal of Pharmaceutical Science and Technology Jul 2016, 70 (4) 382-391; DOI: 10.5731/pdajpst.2016.006494

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Validation of a Spectral Method for Quantitative Measurement of Color in Protein Drug Solutions
Jian Yin, Trevor E. Swartz, Jian Zhang, Thomas W. Patapoff, Bartolo Chen, Joseph Marhoul, Norman Shih, Bruce Kabakoff, Kimia Rahimi
PDA Journal of Pharmaceutical Science and Technology Jul 2016, 70 (4) 382-391; DOI: 10.5731/pdajpst.2016.006494
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Keywords

  • spectral method
  • color
  • CIE L*a*b* values
  • suitability
  • Precision
  • Accuracy
  • Repeatability

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