Light testing

Performance the EP Stray Light Test with Potassium Chloride on UV-Vis Spectrophotometers, Technical Note, Agilent Technologies, Publ. 5988-0945EN, 2000. 

In spite of reports of limited success with borohydride reduction treatments in practice, I would like to add a word of caution. Sodium borohydride is a moderately strong reducing agent. Its interaction with inks and other media is not well understood at present. Therefore, this treatment should be used only when no other option is available. Even then, it should not be undertaken lightly. Testing of all media before treatment of artifacts is strongly recommended. 

One packaging (HDPE bottle with induction seal) Multiple packaging Multiple packaging (multiple count bottles, and multiple material blisters) Consumption test (for bottles) Light test (1200 K lux hours) Micro-testing at annual time points (to test the entire packaging operation and to track the changes over time)... 

Quinine was introduced as a "...primary calibration standard for light testing." In this draft, a "... 5% solution of quinine monochloride dihydrate in water..." Approximately 20 mL of this solution, hermetically sealed in two colorless ampoules (Japanese Industrial Standards No. 5) colorless ampoules or equivalent were to be used. One of these ampoules was to be protected from exposure by being wrapped in aluminum foil, the other exposed at a distance of about 30 cm for three hours. It was specified that "the transmittance of the exposed solution in 1cm cells should lie between 55% and 60%, and that the control should show no significant change (about 70%)." Radiometers were permitted as "...secondary standard UV measuring devices."... 

Piechocki J. Light testing I theory of chemical reactions. APQ Symposium Eighth Annual Meeting and Exposition, of the American Association of Pharmaceutical Scientists, at Lake Buena Vista, FL, Nov. 14-18, 1993. 

Figure 2 Photostability of prednisolone phosphate-eye drops (0.13% FNA, Formularium der Nederlandse Apothekers) stored in different types of containers in the Novasoltest light testing cabinet. ( ) brown glass containers, ( ) uncolored high-density polyethylene containers, (o) clear glass ampoules. Source Ref. 6.

Example of the influence of light test of purity of an active ingredient... 

Table 3. Cutoff filters for stray-light tests. Path length 10 mm...

Note Determined in clear glass vials at 25°C and 10 klx. (Light-testing cabinet fitted with 2x Philips white 35 fluorescent bulbs.)... 

The Japanese recommend that a light test use 1.2xl06 lux hours as a drug substance-product challenge (now part of the ICH Guidelines). 

Light testing should be an integral part of stress testing. [The standard conditions for light testing are still under discussion and will be considered in a further ICH document.]... 

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