Validation for different strengths of drug [August 22, 2004]

[admin]

By Kaoula on Sunday, August 22, 2004 - 05:45 am:

Hi all:
If I have a different strengths of drug and the percent of active ingredients in each strength differ from an other but the excepients is the same what is the rule which you give me to carry out the analytical validation method
the validation is obligatory for all the strengths ??
Thank you
Kaoula

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By Consumer Products Guy on Sunday, August 22, 2004 - 05:59 pm:

If I understand you correctly, I'd validate the assay using the product with the lowest amounts. And I'd just use corresponding smaller sample weights for the higher concentrations.

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By JM on Monday, August 23, 2004 - 08:48 am:

Hi
There is no rule for different strength, but following are gereral understanding,
1. Take the worst case for validation i.e. the formulation with max amount of excipient like for specificity.
2. Cover full range of drug strength in your linearity and other related parametrs.
3.If your test concentration is similar for all strength you can do most of the validation parameters using that concentration. if not you have to do validation of each strength.

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By nome on Thursday, August 26, 2004 - 12:05 am:

what for look alike formulations (same average wt. but different strengths) that generally have different colours.

[mross]

If the product is a modified release then I would recommend full validation for things like recovery but it is not necessary to do linearity etc. if you keep within the right concentration range.

Re-colors---simply add specificity for each color-proving that it does not interfere with the assay.