Light stability test

The molecular encapsulation of flavors with cyclo-dextrins was found to improve the resistence of light sensitive flavor constituents against daylight and ultraviolet irradiation. The photodecomposition of adsorbed and complexed flavors was tested both in the solid state and in aqueous solutions. The results of the light stability tests are demonstrated in the example of complexed and adsorbed citral,beta-ionone and cinnamaldehyde formulations /Table III./. 

Nyqvist H. Light stability testing of tablets in the Xenotest and the Fade-ometer. Acta Pharm Suec 1984 21 245-252. 

Nyqvist H, Wadsten T. Preformulation of solid dosage forms light stability testing of polymorphs as a part of a preformulation process. Acta Pharm Technol 1986 32 130-132. 

There are various accelerated light stability test methods available and/or exposure in harsher climates (Florida, Arizona) to test the weathering performance. The prediction of photoageing stability based on accelerated laboratory testing is very difficult, but some attempts have been made for PVC-P (445). The most relevant point is to use as reference a formulation known to have good outdoor weathering performance. 

Figure 4 Comprehensive description of the lighting cabinet used for exaggerated light stability testing by Lachman and Cooper. American Pharmacists Association (APhA), reproduced with permission. Source From Ref. 35.

Powder Sample Holder for Light Stability Test... 

Figure 5 Detailed drawing to Stahl s powder sample holder for light stability testing. Reproduced with permission PH Stahl and Novartis International AG.

Piechocki, representing FDA, presented a paper titled "Light Stability Testing— Theory of Chemical Reactions" (235) in conjunction with Anderson who dealt with the applications of this science to industrial problems. 

Matsuo was the principal compiler of information for the Research and Technology Committees for Drug Standards, the Osaka Pharmaceutical Manufacturers Association and the Pharmaceutical Manufacturers Association of Tokyo s Basic Study on Establishing a Light Stability Testing Method both basic study and draft Light Stability Test. This information was published by Yatani et al. (288). 

A reference to the use of "Quinine actinometry as a method for calibrating ultraviolet radiation intensity in light stability testing of pharmaceuticals was added."... 

Tonnesen HH, Moore DE. Photochemical degradation of components in drug formulations. Part 2 Selection of radiation sources in light stability testing. Pharm Tech 1993 5 27-34. 

Piechocki J, Wolters R. Light stabUity studies a misnomer. ICH 2 Six-Party Drafting Group on Light Stability Testing Committee Meeting Orlando, Florida, U.S.A., October... 

Piechocki JT. Light stability testing a misnomer. ICH Second International Conference on Harmonisation, Orlando, FL, U.S.A., 1993. 

Matsuo M, Machida Y, Furuichi H, Nakamura K. Study on establishing light stability testing. lyakuhin Kenkyu 1988 19(6) 1028-1052. 

Oxidation and Photolysis. In Chemical Stability of Pharmaceuticals A Handbook for Pharmacists. Kenneth A, Connors, GL Amidon, VJ Stella, eds. NY Wiley, 1986 113. Yoshioka S, Ishihara Y, Terazono T, et al. Quinine actinometry as a method for calibrating ultraviolet radiation intensity in light stability testing of pharmaceuticals. Drug Dev Ind Pharm 1994 20(13) 2049-2062. 

Figure 3 Lachman et al. s lighting cabinet used for exaggerated light stability testing (12).

From the various artificial fight sources that were used in the past in the general field of material light stability testing, specially filtered xenon arc sources and specific fluorescent UV lamps were found to be useful and are therefore specified in the basic standards. 

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