Uniformity of dosage units 2.9.40 instead of uniformity of content 2.9.6

Dear all,

is there any reference regarding the replacement of uniformity of content by uniformity of dosage units??

No reference because they are not interchangeable and are both required. Uniformity of the dosage unit refers to the mass or weight of the dosage form (tablets, capsules…). Whereas content uniformity refers to the potency of the drug or API in dosage form (mg, ug…).

It is conceivable that someone leaves the ‘good stuff’ out (API) but the dosage form weighs within specification! Thus, the 2 regulations.

but if I apply the uniformity of dosage units 2.9.40 by content uniformity, I think that it’s the same thing, perhaps more complete than 2.9.6??

PLease see the below link


I would be careful with this information. It is not true in the US so it depends where you are selling your drug product. In addition, you have to show compliance in the EU which means a risk assessment and demonstration that weight alone of the dosage unit is enough. This may be true for a dietary supplement (big as a horse pill) but is not true for potencies measured in small milligrams or sub milligrams (like a sex hormone or titruation).