Table 1.
Products for oral use | Content | Endotoxin by LAL (EU/mL) |
Endotoxin by MAT (EEU/mL)a |
Endotoxin by rFC (EU/mL) |
---|---|---|---|---|
Product 1, batch 1 | Viable Ent. faecalis DSM 16440 | <200 | <100 | <100 |
Product 1, batch 2 | <200 | <100 | <100 | |
Product 2, batch 1 | Viable E. coli DSM 17252 | 1750 | >4000 | 1371 |
Product 2, batch 2 | 928 | >4000 | 903 | |
Product 3, batch 1 | Lysed Ent. faecalis DSM 16440 | 51 | 147.8 ± 426.2 | 1.2 |
Product 3, batch 2 | plus E. coli DSM 17252 | 33 | 105.1 ± 4.9 | 0.9 |
Product 3, batch 3 | n.d. | 61.7 ± 6.6 | n.d. | |
Product 4 | Lysed E. coli Laves | <1.00b | <1.00b | <0.5b |
Product 5 | Viable E. coli DSM 6601 | 397,000 | <100,000 | 73,400 |
Product 6 | E. coli extract ATCC 25922 | <100,000 | 165 | <5,000 |
Product 7 | E. coli extract ENR 2176116 | <100,000 | 92 | <5,000 |
aEEU: endotoxin equivalent units. The samples were diluted up to 4000 times in endotoxin-free water prior to testing with a dilution factor determined by pilot experiments.
bBelow the detection limit of the method.