degradants

[chris knutsen]

In performing a method validation for pharmaceuticals, one of the steps involves performing a degradation study. On of the degradation steps is the us of UV light. Can people tell me what they are using to do this? Are they using a light box, etc?

Thanks

[JZeszotarski]

ICH Q1B provides guidelines for photostability studies of new drug substances and products. We use photostability chambers that are designed to provide the UV and visible light flux required by ICH guidelines. If you want to use a "lightbox", you would need to calibrate the amount of light (both UV and visible) in order to duplicate ICH conditions.

Hope that helps.

[yogesh#14]

In performing a method validation for pharmaceuticals, one of the steps involves performing a degradation study. On of the degradation steps is the us of UV light. Can people tell me what they are using to do this? Are they using a light box, etc?

Thanks

Hi , The ICH guidelines mentions photostability testing for active ingredients and finished dosage form with required quality and quantity of light in LUX/hrs. You can refer the same.

regards,

Yogesh