Discussion about the topics related to pharmaceutical research and development (R&D).
How to adjust the potency of Tamsulosin HCl in BMR according to the assay report (99.74%).?
Generally in Pharma R & D the quantity of drug (API) to be added in a batch is adjusted to 100% based on its potency or % assay by applying correction factor as follows,
Correction factor = 100 / % Assay (potency) obtained as per Assay report
Quantity to be added in a batch = Theoritical quantity X Correction factor (as above)
Similarly we can calculate the quantity of drug (API) to be added in a batch on moisture free basis (taking in to account actual moisture content obtained as per COA report of that drug (API). The calculation is as follows,
Correction factor = 100 / (100 - % moisture content in the API)
Quantity to be added in a batch = Theoritical quantity X Correction factor (as above)
For example, For Amoxicillin trihydrate the actual quantity to be added in a batch is calculated based on actual moisture content obtained in Amoxicillin trihydrate API.
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thankyou.
Is it compulsory to adjust potency to 100% when we are formulating extended release drug product?
It is not mandetory to adjust potency / Assay to 100% when formulating any pharmaceutical product. In any case it must comply finished product specification in which Assay is also included.
Generally, there is no need to adjust potency to 100% in the formulation, if assay limit of that API (Active ingredient) is 98% or above (in tht raw material API). If assay limit of API (as a raw matewrial) is less than 98% or if there is moisture content (significant amount) then it is necessary to compensate for assay and moisture content to 100% in the formulation. This is required to achieve assay value within limit as per finished product specification as well as to be within limit up to shelf life (up to expiry date) of that formulation.
There should be internal R & D policy or SOP to govern this aspect.
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thanks
You are always welcome.
Hi
Is there any guideline reference to follow below statement
Calculate the quantity of API if assay is below 100% on as is basis. If the assay is 100% or above consider the theoretical quantity.