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Pharmaceutical Yield Calculation

The document discusses pharmaceutical yield calculation, which is crucial for minimizing process loss in manufacturing. It explains how to calculate percent yield using the ratio of actual to theoretical product quantities, providing an example with a yield of 99.0%. It also emphasizes the importance of establishing tight yield limits and adhering to FDA regulations regarding yield determination during manufacturing phases.

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1K views3 pages

Pharmaceutical Yield Calculation

The document discusses pharmaceutical yield calculation, which is crucial for minimizing process loss in manufacturing. It explains how to calculate percent yield using the ratio of actual to theoretical product quantities, providing an example with a yield of 99.0%. It also emphasizes the importance of establishing tight yield limits and adhering to FDA regulations regarding yield determination during manufacturing phases.

Uploaded by

GAMES FOR ALL ,ALL FOR GES
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Home  Calculation

Pharmaceutical Yield Calculation


October 18, 2022

Yield calculation or reconciliation is the final manufacturing stage of pharmaceutical products. Percent
yield is very important in the manufacture of pharmaceutical products to reduce the process loss.

Yield is usually measured in percentage and it is the ratio of input materials to output products or ratio of
the theoretical quantity of the product to the actual quantity of the product and its formula is as follow,

%Yield = (Quantity of good product after manufacturing/Quantity of the product before manufacturing) ×
100

or

%Yield = (Actual Quantity of Products ÷ Theoretical Quantity of Batch size) × 100


Example

In the pharmaceutical industry, a batch of tablets was manufactured having 100 kg standard batch size
after dispensing and 99.0 kg after coating. Calculate the yield of the product.

By using above formula add values in it as follow

% Yield= (99÷100) × 100 = 99.0%

So, yield of the product is 99.0%.

Where,

% of Loss = 100 - Actual yield against Theoretical yield.

Yield Limit

Yield limit should be as tight possible to reduce process loss. But should not be impossible something
(i.e., 99%-100%).

That's why it should be established from process optimization batch to process validation batches. Annual
product review an appropriate option to set the optimum yield range/limit.

As per FDA 21 CFR § 211.103,

Actual yields and percentages of theoretical yield shall be determined at the conclusion of each
appropriate phase of manufacturing, processing, packaging, or holding of the drug product.
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