JOURNAL OF THE CZECH PHARMACEUTICAL SOCIETY AND THE SLOVAK PHARMACEUTICAL SOCIETY

Čes. slov. farm. 2018, 67(1):30-31 | DOI: 10.36290/csf.2018.004

Theory and practice of pharmacopoeial control of the quality of drugs and excipients VII. The colour reference solutions of the European pharmacopoeia (Ph. Eur.)

Jan Šubert, Jozef Kolář1,2,*, Jozef Čižmárik3
1 Veterinární a farmaceutická univerzita Brno, Farmaceutická fakulta, Ústav aplikované farmacie, Brno
2 Univerzita veterinárskeho lekárstva a farmácie v Košiciach, Katedra lekárenstva a sociálnej farmácie
3 Univerzita Komenského v Bratislave, Farmaceutická fakulta, Katedra farmaceutickej chémie

Data calculations of three different workplaces consistently show that the difference in colour ΔE (CIELAB) of some colour reference solutions according to Ph. Eur. with small colour and purified water are too small. As a result, there is failure with use of these solutions for visual assessment of the coloration of the liquids. Solving the problem in Ph. Eur. presupposes the introduction of instrumental colour evaluation into this pharmacopoeia.

Keywords: Ph. Eur.; colour reference solutions; colour difference; CIELAB; visual assessment; instrumental measurement

Received: December 19, 2017; Accepted: January 3, 2018; Published: January 1, 2018  Show citation

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Šubert J, Kolář J, Čižmárik J. Theory and practice of pharmacopoeial control of the quality of drugs and excipients VII. The colour reference solutions of the European pharmacopoeia (Ph. Eur.). Čes. slov. farm. 2018;67(1):30-31. doi: 10.36290/csf.2018.004.
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References

  1. European Pharmacopoeia (Ph. Eur.) 9th Ed. Strasbourg: EDQM Council of Europe 2017; s. 22-23. http://online6.edqm.eu/ep902/ (06. 12. 2017).
  2. Pack B. W., Montgomery L. L., Hetrick E. M. Modernization of physical appearance and solution color tests using quantitative tristimulus colorimetry: advantages, harmonization, and validation strategies. J. Pharm. Sci. 2015; 104, 3299-3313. Go to original source... Go to PubMed...
  3. Wyszecki G., Stiles W. S. Color science: Concepts and methods, quantitative data and formulae, 2nd ed. New York: Wiley 2000; 950 s.
  4. Šubert J., Farsa O., Gajdošová Z. Properties of colour reference solutions of the European Pharmacopoea in CIE L* a* b* colour space. Pharmazie 2006; 61, 1047-1048.
  5. Swartz T. E., Yin J., Patapoff T. W., Horst T., Skieresz S. M., Leggett G., Morgan C. J., Rahimi K., Marhoul J., Kabakoff B. A spectral method for color quantitation of a protein drug solution. PDA J. Pharm. Sci. Technol. 2016; 70, 361-381. doi: 10.5731/pdajpst.2016.006486 (30. 6. 2016). Go to original source... Go to PubMed...
  6. Bogdansky F. M. Measurement of surface color and color difference of tablet colorants by tristimulus colorimetry. J. Pharm. Sci. 1975; 64, 323-328. Go to original source... Go to PubMed...
  7. Müller A., Moll F. Reflexionsspektrometrische Qualitätskontrolle gefärbter Arzneiformen II: Numerische Parameter der Farbeinheitlichkeit. Acta Pharm. Technol. 1985; 31, 224-229.
  8. Stark G., Fawcett J. P., Tucker I. G., Weatherall I. L. Instrumental evaluation of color of solid dosage forms during stability testing. Int. J. Pharm. 1996; 143, 93-100. Go to original source...
  9. Mokrzycki W. S., Tatol M. Colour difference ∆E-A survey. Machine Graphic & Vision 2011; 20, 383-411.
  10. Ali S. L., Castle P. Measurement of colour of liquids. Pharmeuropa 2003; 15, 262-267. Go to original source...




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