Drug Product ASSAY vs Drug Product POTENCY

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[@sabarikrish9405]

95 sir. Great work sir.

[@omkarainapure9192]

Nice video sir

[@pharmagrowthhub3083]

So nice of you

[@dragpalsinghbundela3685]

98%

[@manilpatel8556]

Sir, I want to know if our API molecule is entirely new, and there are no research articles about that API. In this condition, how do we decide the limit of Assay? Is this particular point mentioned in any guidelines

[@pharmagrowthhub3083]

According to the ICH Q6A guidelines, the specification for a new API, including the assay limit, should be based on a combination of data from various sources. This includes developmental data, pharmacopoeial standards, test data from clinical and toxicology studies, and results from stability studies.

[@gitoridaniel6753]

100

[@hingusneh2032]

Some assay above 100% May percentage is not more than 100 How can it possible 105% assay ?

[@pharmagrowthhub3083]

Here are a few reasons why this might happen in case of drug product and drug substance: Overestimation due to Impurities: If the sample being assayed contains impurities that react in the assay in a similar way to the substance being measured, it could result in an overestimation of the concentration of the target substance. Manufacturing variability: The API amount added during manufacturing may impact on assay (for drug product). Analytical Variability: Every analytical method has a degree of variability or error. Sometimes, this variability can lead to results slightly above the expected maximum, particularly if the method is not perfectly calibrated or if there are small errors in the procedure. Calibration Error: If the equipment used for the assay is not calibrated correctly, it might give readings that are higher than the actual value. This is a common issue in various analytical techniques.

[@hingusneh2032]

@@pharmagrowthhub3083 thank you so much sir for reply 🙏