Calculate the yield when 25 liters of formulated Drug Substance is sterile filte

Question

Calculate the yield when 25 liters of formulated Drug Substance is sterile filtered into 12,150 vials containing 2 milliliters of Drug Product.

Calculate the yield when 42 liters of clarified lysate at 2.1 gram/liter protein is purified by column chromatography to yield 16 kilograms at 4.4 gram/liter protein.

Calculate the yield when 90,000 unlabeled vials were sent to the labeling machine and 89,100 labeled vials were returned to the GMP warehouse.

Calculate the yield when 78.0 grams of intermediate is reacted to form 63.3 grams of Drug Substance.

Explanation / Answer

Ans 1)

12150 vials are filled with 2 ml of drug product.

So, actual drug quantity is 12150 X 2 ml = 24,300 ml = 24.3 lt.

Theoritical yield was 25 lt.

% Yield = Actual / Theoritical X 100 = 24.3 / 25 X 100 = 0.972 X100 = 97.2 %

Question 2 is not clear.

Ans 3) 90000 unlabelled vials are theoritical which 89100 is actual

yield = 89100 / 90000 X 100 = 0.99 X 100 = 99 %

Ans 4) 78 gms of intermediate is theoritical yield and 63.3 gm is actual yield

Yield = 63.3 / 78 X 100 = 0.811 X 100 = 81.1 %

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