Hello all,
We have a product in R&D (research & development) that we have in our accelerated stability chamber (higher temperature and humidity than ambient) and at the last time point, six months, we found that the sample has many thick strand-like pieces in it. The 4-month sample was not like this. We pulled another 6 month sample. It too had the particles. This is very unusual and not typical. This is not like the normal debris on the bottle dropper. Under the microscope, it looks blobby and plant-like (like something that would be from a plant) like fatty or greasy, but it does not look like bacteria or fungus.
The formulation includes herbal extracts of Echinacea and goldenseal as well as citric acid, glycerin, and some essential oil. What do you think the pieces in the samples could be?
We are regulated in the United States under 21 CFR Part 111 and 117 and we have SQF and NSF GMP certifications for manufacturing dietary supplements.
Thank you,
Matthew
