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Pharmaceutical Product Safety Laboratory needed for Microbiology testing and product safety testing of excipient to obtain GRAS status. Acne: propionibacterium zones of inhibition, staph species involved in acne also; MIC value (minimum inhibitory concentration)
2) USP 51 antimicrobial test
3) Antiseptic challenge: 5 microbes: E coli, Staph aureus, pseudomonas aeruginosa, candida albicans, aspergillus niger.
4) Safety for personal care: skin and ocular irritancy, allergenicity, mutagenicity, genotoxicity, sensitization
5) Product Actives and Stability:
6) Product Actives and Stability:
a. What moiety is responsible for antimicrobial activity, organic or inorganic compounds?
b. What effective concentration are present and are they consistent throughout the clay
c. Is a group of compounds in the hexane fraction or are they inorganic iron ferrous compounds?
d. Are the ferrous compounds complexing with other metal ions or polyatomic anions, coordinated covalent metal compounds?
e. If they are ferrous compounds what is the redox stability as related to antimicrobial efficacy
f. How do antioxidant preservatives and pH affect efficacy, i.e. effective operating pH range
g. Do antioxidants affect pH status?
h. What is the stability of clay actives binding or complexing to cosmetic product matrix constituents, including antioxidants, lipids, proteins, and other carriers such as starches.
i. What are solubility of actives, can they settle out or precipitate, especially when mixed with other cosmetic matrix components?
7) Products specification: Shelf life(stability), solubility, concentrations, pH, heavy metals, microbiological, density, etc.
8) Product composition: Will there be a line of standardized clay products, are some refined and if they standardized for effective actives what are levels?
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