Bacterial endotoxin of water for injection

Microbiology
1

how to calculate mvd of water for injection to test bacterial endotoxin test

2

WFI BET limit is 0.25 EU/ml

EL= K x N / V
Where, K = 0.25 EU/ml
N = no. of sample
V = sample volume

So that, EL = 0.25 x 1 / 1
EL = 0.25 EU/ml

Now, MVD = EL x Potency / Lysate sensitivity

Where, EL= 0.25 EU/ml
Potency = 1
Lysate sensitivity = 0.03 or 0.0625 or 0.125 (depend on sensitivity)
MVD = 0.25 x 1 / 0.031
MVD = 8

I try my best.

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