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In Benzoyl Peroxide Stability Study, Benzene Forms At 'Hundreds' PPM 'In A Few Weeks' – Valisure

 
• By Malcolm Spicer

As stability temperature for study of 66 products, it says 50°C is recognized as reasonable temperature product may be exposed to during distribution and handling and is accepted temperature used by pharma industry for accelerated stability studies of at least three months.

• Source: Shutterstock

Valisure LLC’s research with benzoyl peroxide drugs included an initial stability study of five products showing benzene in dozens of parts per million can form in a few weeks at 37°C (98.6°F) and hundreds at 50°C (122°F) while 70°C (158°F) “often would lead BPO product packaging to burst.”.

According to its citizen petition filed on 5 March with the Food and Drug Administration, it chose 50°C as...

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More from Policy & Regulation

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