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. 2018 Aug 21;8(3):63–69. doi: 10.1556/1886.2018.00017

Table 1.

Results of three quantitative endotoxin tests by laboratory 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.