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Extraction in DMF, GC-FID quantification
Direct measurement at 25°C with conductivity cell
Simulated use extraction, GC-FID headspace analysis
Additional extraction cycle for EO/ECH
Direct pH measurement at 25°C with calibrated electrode
Method validation with count standards at 10µm and 25µm
Direct water analysis by combustion/oxidation method
Extraction in particle-free water, light obscuration counting
Membrane filtration, TSA plate count, 3d at 30-35°C
Direct LAL test on water sample
Recovery test with B.subtilis spike on products
Recovery efficiency + method suitability + 2 ID of dominants
Extraction, filtration, TSA incubation 3-5d at 30-35°C, aerobic conditions
Anaerobic incubation on TSA or FTM media, 5-7 days
Extraction/rinse, filtration, TSA 3-5d & SDA 5-7d incubation
Kinetic chromogenic LAL assay, 0.005-5.0 EU/ml range
Screening at multiple dilutions to find valid test range
Interference test at 3 dilutions with spike recovery
Growth promotion with 5 strains on TSA plates
Growth promotion test with C.albicans, A.brasiliensis on SDA
Membrane filtration, R2A agar incubation 7d at 20-25°C
Direct inoculation or membrane filtration, 14d at 20-25°C & 30-35°C
Method suitability study for product-specific sterility testing
Bacteriostasis/fungistasis test with 6 challenge organizms
Rabbit intradermal injection of polar/non-polar extracts
Rabbit pyrogen test, saline extract, temperature monitoring
GLP-compliant rabbit pyrogen test with saline extract
ICP-MS analysis for heavy metals suite
Particle extraction, SEM imaging + EDX elemental mapping
Additional SEM-EDX analysis on subsequent samples