Color Stability of Tablet Formulations IV

Stability of Solids and Solid Dosage Forms

“…Other reports (113)(114)(115)(116)(117)(118)(119)(120) established that the decay pattern consists of three consecutive first-order decays (Fig. 28) and stressed that the fad- 1 3 1 1 3 3 0 2 1 2 0 1 3 4 2 3 3 5 3 5 0 3 2 4 38 49 34 43 37 38 42 60 38 45 44 49 38 65 46 66 39 40 39 47 41 50 41 63 ~~ 31 38 30 35 32 35 31 38 30 34 31 35 32 56 36 53 34 37 31 45 28 45 34 61 a Values in fourth and fifth columns represent scoring from 1 to 6 for degree of color change (1 = unchanged, 6 = substantially changed) and from 1 to 6 for degree of fineness change.…”

“…It has been established (113)(114)(115)(116)(117)(118) that when the fading has penetrated to a depth of 0.03 cm, the tablet surface appears white and that the faded layer does not become thicker upon further light exposure. This has also been demonstrated for plastics (121)(122)(123).…”

Measurement of Surface Color and Color Difference of Tablet Colorants by Tristimulus Colorimetry

“…Fullerton, Calif. 7 The Colorimetry Commission of CIE has defined standard spectral distributions at various color temperatures, and the source D-650, with a color temperature of 6500°K, has been selected as typical of average daylight (Ref. 19, p. 7).…”

“…Some work also has been reported on color determination and color control in the food industry (3, 4). More recently, colorimetry has been employed in the determination of color stability of pharmaceutical tablet formulations (5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18) and in the production of color matches for solid dosage forms (19)(20)(21). This work describes the measurement of surface color by tristimulus colorimetry and the determination of color specifications for the routine control of tablet colorants.…”

Stability of Certified Dyes in Tablets III

“…ETfioDS OF determining the stability of pharmaceutical colorants have appeared in several reports (1)(2)(3)(4)(5). Spectrophotometric measurements have provided a physical evaluation of color; but, in order to obtain a quantitative color measurement which relates to human color perception, colorimetry must be used.…”