1 2 Million Lux Hours

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ICH Q1B Guideline Photostability Testing of New Drug ...

    http://www.remilabworld.in/img/download_pdf/ICH%20Q1B%20Guideline.pdf#:~:text=1.2%20million%20lux%20hours%20%3A%2055%20klux%20%3D,the%20temperature%20increases%20if%20the%20irradiance%20is%20raised.
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Photostability - Light Measurement

    https://light-measurement.com/photostability/
    The product under test must receive a measured dose of both UV-A (200 watt-hours per square meter) and Visible (1.2 million lux-hours) optical radiation exposure. This requires both radiometric and photometric measurements in …

Pharmaceuticals Validation and stability-Technical …

    https://brvalidations.blogspot.com/2012/12/how-to-understand-time-required-to.html
    For the test sample to get exposed to 1.2 million lux hr, it has to be kept in photostability chamber for the following number of days. Y = 1.2 x 106 lux hr / 4430 lux = 270.88 hr = 271 hr. Converting hours into number of days = 271 hr/24 hr = 11.29 days ~ 11.5 days. ICH Q1B Requirement :

1 2 Million Lux Hours - hoursfinder.com

    https://hoursfinder.com/0-9-hours/1-2-million-lux-hours.html
    ICH Q1B C 35 The second mentioned radiant exposure, • 1.2 million lux hours, is limited to the visible range from approx. 400 nm to 800 nm. The irradiance level in the Suntest may be adjusted from min. 250 to max. 765 W/ m²

FREQUENTLY ASKED QUESTIONS: PHOTOSTABILITY

    https://www.caronproducts.com/files/docs/White-Papers/PhotostabilityFAQRevA.pdf
    lighting. Drugs must be exposed to at least 1.2 million lux-hours of visible light and 200 W-Hr/m2 of UVA (near UV) light. Q1B does not specify either temperature or humidity parameters during testing, other than to require “appropriate” control of temperature to “minimize…localized temperature changes”.

1.2 million lux hours | English to Russian | Medical ...

    https://www.proz.com/kudoz/english-to-russian/medical-pharmaceuticals/5016688-12-million-lux-hours.html
    English term or phrase: 1.2 million lux hours : 1) Photolytic degradation: Sample preparation: Expose the 10 mL of sample stock solution under UV and white light for 1.2 million lux hours in each of 50 mL of clear glass flask volumetric flask, amber colored 50 mL glass volumetric flask and flask covered with aluminum foil. Dilute this solution to 50 mL with diluent 2.

Guidance for Industry

    https://www.fda.gov/media/71713/download
    illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 watt hours/square meter to allow direct comparisons to be made between the drug ...

ICH Q1B Guideline Photostability Testing of New Drug ...

    http://www.remilabworld.in/img/download_pdf/ICH%20Q1B%20Guideline.pdf
    200 Wh/m² : 68.9 W/m2 = 2.9 hours Confirmatory studies 1.2 million lux hours At min. irradiance level: 1.2 million lux hours : 55 klux = 21.8 hours At maximum irradiance level 1.2 million lux hours: 170 klux = 7.1 hours Higher irradiance levels shorten the test duration by the factor 3, but the temperature

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