Photostability testing

Stability Testing of New Drug Substances and Products Stability Testing Photostability Testing of New Drug Substances and Products Stability Testing for New Dosage Forms... 

GL5 Stability 3 Stability testing photostability testing of new drug substances and products... 

QIB Stability Testing Photostability Testing of New Drug Substances and Products Stability... 

As with drugs and purified biomarkers, thermal- and photostability of botanical products are the factors that must be considered. Commercial dried extract and capsules of SJW were evaluated under harmonized test conditions (25). Photostability testing showed all the constituents to be photosensitive in the tested conditions. However, different opacity agents and pigments influenced the stability of the constituents. Amber containers had little effect on the photostability of the investigated constituents. Long-term thermal stability testing showed a shelf life of less than four months for hyperforins and hypericins, even when ascorbic and citric acids were added to the formulation. 

U.S. Food and Drug Administration (FDA) (1997), Guidance for industry, ICH Q1B, Photostability testing of new drug substances and products, FDA, Rockville, MD. 

Drew, H. D., Thornton, L. K., Juhl, W. E., and Brower, J. F. (1998), An FDA/PhRMA interlaboratory study of the International Conference on Harmonization s proposed photostability testing procedures and guidelines, Pharmacopeial Forum, 24(3), 6317. 

International Conference on Harmonization (ICH) (1996), Harmonized tripartite guideline on stability testing Photostability testing of new drug substances and products, Q1B, 1996 ICH, Geneva. 

Stress Testing (drug product) — Studies undertaken to assess the effect of severe conditions on the drug product. Such studies include photostability testing (see ICH Q1B) and specific testing of certain products (e.g., metered dose inhalers, creams, emulsions, refrigerated aqueous liquid products). 

FDA Guidance for the Photostability Testing of New Drug Substance and Products (May 1997)... 

In the case of photostability testing the pharmaceutical ingredient may be subjected to xenon, metal halide, near UV, or cool white fluorescent lamp exposure. 

Anderson NH, Johnston D, McLelland MA, Munden P. Photostability testing of drug substances and drug products in UK pharmaceutical laboratories. J Pharm Biomed Anal 1991 9(6) 443. 

Evaluation of the propensity of a drug substance (or formulation) to undergo photodegradation should be guided by the ICH QIB guidance document on photostability testing (48). As this topic has been covered extensively elsewhere (49-53), including Chapter 10 in this book, it will not be discussed in detail here. 

The publication of the ICH guidelines as to how to carry out photostability tests on new pharmaceutical drug substances and drug products... 

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