[Theory and practice of pharmacopoeial control of the quality of drugs and auxiliary substances. VI. Stability of comparative colour solutions of the Czech Pharmacopoeia 2002]. / Teorie a praxe lékopisné kontroly jakosti léciv a pomocných látek VI. Stabilita porovnávacích barevných roztoku CL 2002.

Comparative colour solutions for methods I and II evaluating colouring of liquids according to PhB MMII are of identical composition. For method I, they can be stored without any time limit, whereas for method II are to be prepared just immediately prior to their use. The present paper deals with the examination of stability of comparative colour solutions PhB MMII kept in test-tubes made of colourless borosilicate glass with ground-glass stoppers, protected from light. The colour differences deltaE* in the uniform colour space CIELAB calculated from transmittance spectra measured in the course of preservation of solutions revealed that comparative colour solutions PhB 2002 show higher stability when there is a higher concentration of colour components in the solution. In solutions H9, HZ7, and Z7, the time period from their preparation to the time not exceeding the difference of deltaE* 1.5 units ranged within 3 days, in ZZ7 it was at least 14 days, and in C7 at least 20 days. In solutions H5, HZ4, Z4, ZZ4, and C4, it was at least 25 days, in solutions H2, HZ2, Z2, ZZ2, and C2 at least 41 days. These findings make questionable the justification of preservation of colour solutions according to PhB MMII for method I for an unlimited time period. At the same time they show that the solutions are not unstable to such an extent that they should be prepared for method II just prior to use in all cases.

Properties of colour reference solutions of the European Pharmacopoea in CIE L*a*b* colour space.

The coordinates of CIE L*a*b* uniform colour space have been acquired from the transmitance spectra of colour reference solutions of European Pharmacopoeia (Ph.Eur.). Calculation of colour differences of these solutions from purified water deltaE* gave their values in the range between 0.7 (B9 solution) to 36 (Y1 solution) CIE units. Excluding red colour reference soulutions, deltaE* values did not depend on concentrations of colour compounds linearly. Small deltaE* values founded by the brown and brownish-yellow colour reference solutions of the lowest concentrations can possibly cause some problems of visual examination of the degree of coloration of liquids according to Ph.Eur.