AET is the threshold at which analytical techniques can detect the compounds. AET for parenteral products can be calculated using following formulas: 1) for liquid injectables
AET (extractable) = (SCT*LC*Vc)/(MDD*Ve)
AET (leachable) = ( SCT*LC)/MDD
Where, AET = Analytical evaluation threshold in microgram/ ml of extraction solution for extractable and microgram/ml of drug product for leachable SCT = 1.5 microgram/day for parenterals LC = Label claim of drug product mg/ml (i.e. drug product in ml shall be considered) Vc = Volume of drug product in one container i.e. fill volume of drug product in ml MDD = maximum daily dose of drug product in mg/day considering mg of main component Ve = volume of extraction solvent used in ml
2) for solid injectables i.e. sterile powder, lyo products
AET (extractable) = (SCT*LC)/(MDD*Ve)
AET (leachable) = ( SCT*LC)/(MDD*Vr)
Where, SCT = 1.5 microgram/day for parenterals LC = Label claim of drug product mg/vial (i.e. drug product in mg of main component shall be considered) MDD = maximum daily dose of drug product in mg/day considering mg of main component Ve = volume of extraction solvent used in ml Vr = volume of dilution/ reconstitution solution used in ml
Note: due to uncertainties of anaytical techniques, 50% of AET shall be reccomend as reporting threshold
AET is the threshold at which analytical techniques can detect the compounds.
ReplyDeleteAET for parenteral products can be calculated using following formulas:
1) for liquid injectables
AET (extractable) = (SCT*LC*Vc)/(MDD*Ve)
AET (leachable) = ( SCT*LC)/MDD
Where,
AET = Analytical evaluation threshold
in microgram/ ml of extraction solution for extractable and microgram/ml of drug product for leachable
SCT = 1.5 microgram/day for parenterals
LC = Label claim of drug product mg/ml (i.e. drug product in ml shall be considered)
Vc = Volume of drug product in one container i.e. fill volume of drug product in ml
MDD = maximum daily dose of drug product in mg/day considering mg of main component
Ve = volume of extraction solvent used in ml
2) for solid injectables i.e. sterile powder, lyo products
AET (extractable) = (SCT*LC)/(MDD*Ve)
AET (leachable) = ( SCT*LC)/(MDD*Vr)
Where, SCT = 1.5 microgram/day for parenterals
LC = Label claim of drug product mg/vial (i.e. drug product in mg of main component shall be considered)
MDD = maximum daily dose of drug product in mg/day considering mg of main component
Ve = volume of extraction solvent used in ml
Vr = volume of dilution/ reconstitution solution used in ml
Note: due to uncertainties of anaytical techniques, 50% of AET shall be reccomend as reporting threshold