What is the permissible overage (excess) of API in drug product formulation. Is there a reference for these limits? and what about vitamins, I found some vitamins formulation containing 25% excess amount.
Hello, in 3AQ11a guidance there is a mention about vitamins overage for Pharmaceutical products.
There is no specific limits for the overage. I think it can be used even more than 25%.
Refer page 5
https://www.fda.gov/downloads/drugs/guidances/ucm073507.pdf
It will depend on the case specific, and the maximum therapeutic qty of the API.
The overages should not be used to compensate the API degradation loss, it should be used to compensate the process or handling loss.
For vitamins and minerals, according to the limit stated in the United States Pharmacopoeia, the assay can reach up to 150-165%.
It depends on your stability study and the assay of API regulated in formulated product in pharmacopoeia also.
Moreover, it also depends on your manufacturing loss.
According to the International Pharmaceutical Federation, the amount of overages can up to max. 30% of labeled amount.
Can we mention the overages by specifying it as stability overages or manufacturing overages for API, not salts?
According to USP the assay limit for Oral Suspension (Dry syrup) is 90- 120 %. In our formulation we had 10 % Overages. How can we justify the overages since there is no variability in manufacturing and testing method (system suitability RSD less than 2%).
Can we put overages based on assay limit which is higher than usual limit (90-110 %) ?
Sabyata Pharmacy: overage would be justified by assay content degradation over time (syrup, liquid formulation), not by manufacture and testing.
but i thought overage based on degradation was only allowed with Vitamins products. Does it also apply for antibiotic products such as cefixime in Dry syrup form? Can anyone point out some regulatory guidance which clarifies overage incorporation? Cefixime has assay range 90-120 %.
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