Uniformity of Content: regulatory affairs

[A.Nonymous]

I'm not sure if this is the right forum to post this, but I don't know some others.

If you have to do a uniformity of content on tablets which are highly dosed (eg 2000 mg API) but the solubility is very poor (1mg/ml or less), what options do you have, or in other words which options are conform the regulations?

I know we can add one tablet to a volumetric flask of 2000 ml, but to do this 10 times????

Other option is to weigh the entire tablet, pulverize and weigh only 1/8 or something suitable, and calculate the content for the entire tablet.

Searching for another solvent where the solubility is higher isn't an option, there are really poor soluble API's

please give me some clarification about this
(or let me know where I can get this clarification)

Thanx

[Lime]

You probably know that but for highly dosed forms you don't have to perform Cont. Uni. If you have to do it then 1 dosege form into 2000 mL solvent ( suppose your methods requirement ) is the best way to me.

hope helps

Lime

[ravi]

What regulatory agency are you trying to satisfy? There are guidelines for this (ich.org comes to mind). For content, I think you need some statistical number.

[syx]

USP <905> Uniformity of Dosage Unit:
When the test for content uniformity is not required, the test for weight variation may be applied in any of the following situations:
1) products containing 50 mg or more of an active ingredient comprising 50% or more, by weight, of the dosage unit or, in the case of hard capsules, the capsule contents, except that uniformity of other active ingredients present in lesser proportions is demonstrated by meeting content uniformity requirements; …