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Advice for OTC sunscreen stability tests + lab & stability chamber recs
We are a small manufacturer of OTC sunscreens and Skin protectants and are looking for advice and leads on the following:
1. Sources of economical stability chambers that test temperature and humidity.
2. What tests can we conduct in house to document stability (provided we have a stability chamber), and what are the minimum tests that must be carried out by an external certified lab?
3. Does anyone have recommendations for reasonable and qualified testing labs?
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1 Reply
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We use a Memmert HPC150 chamber and it works like a charm. How “economical” would be your call but Memmert makes many sizes to suit different folks. As for tests to conduct, standard accelerated stability conditions for pharma are 45C at 55% RH success over 90 days for prelim approval of a given formulation depending on its constitution (some formulations require lower temp/longer time.) Besides assay of your API - the most important test - you will also record pH, viscosity and any signs of discoloration or decomposition over the course of the shelf life and one year beyond. Testing labs? Too many to list, depends on your location.
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