USA, Canada analytical chemistry laboratory needed for ICH USP Stability Testing. ICH USP Finished product stability testing on liquid sample of ionic silver (ingredients are water and ionic silver). 12 tests are required over time 0, 3, 6, 9, 12, 18, 24 and 36 months.
1. Appearance (USP, organoleptic)
2. Colour (USP, organoleptic)
3. Odour (USP, organoleptic)
4. Antimicrobial effectivenss (USP 51 or equivalent compendial or pharmocopeia method)
5. Total aerobic count (USP 61 Microbial limit test)
6. Yeast and mold count (USP 61 Microbial limit test)
7. Escherichia coli (USP 2022)
8. Staphylococcus aureus (USP 2022)
9. Salmonella spp (USP 2022)
10. Pseudomonas auriginosa (USP 2022)
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