if endotoxin limit of a raw material is less than 0.5 Eu/mg, how can i compensate in MVD equation
Calculate concentration of raw material in endotoxin sample, eg 1 gram of raw material in 1,0 mL of LAL water. Limit of sample would be 0.5*1000/1mL = 500 IE/mL. Divide by lowest point of calibration curve, eg 0.001 IE/mL. MVD = 500/0.001 = 500,000.
at first thanks a lot for ur response but i need to know if monograph says endotoxin limit is less than 0.5 Eu/mg not equal, i compensate directrly in the MVD equation