Which is more accurate way to calculate Potency?

[jarednathan]

Sorry, but just to complete the conversation, I did forget that the usual miscalculation would produce a result lower than necessary. In a way, that would be good since an OOS would not be generated. Although it would be possible that an OOS had been obtained when it wasn't really one. That kind of justification (over-estimating an impuity) is the usual tactic to take when one isn't sure. Therefore, in your case, if a number was ever generated on a decimal point off, it'd be a worst-case scenario. Basically, no batches would have been effected.

If you ever have any other questions or want to bounce an idea off someone for a second opinion, please don't hesitate to contact me.

Cheers

[kcvichare@yahoo.com]

I found there are two ways to calculate potency when issuing a COA:

1. potency = 100%- total impurities by HPLC-- water content% - residual solvent% - counter ion%

2. potency = (100%- total impurities by HPLC) x (100% - water content% - residual solvent% - counter ion%)

Which way is more accurate to use for issuing a COA? Can anyone tell me where I can find the origins of these two equations?

Thanks~
Apple

1st one correct, 2nd one is wrong.

[HPLC chemist]

Neither.

[Jowo]

Hi,
I hope you can tell me whether below is correct:

When calculating the amount of trihydrate API salt required per batch would you:

1. Calculate the % molar mass of the free acid required per unit dose formulae (that is free acid molar mass/total molar mass x100)
Then calculate the actual weight required per unit dose:
( 100x weight of free acid required)/% of free acid in a salt

2. Calculate the potency (from COA; based on assay and KF) = assay x KF moisture/100.

3. Recalculate amount required per batch.

Am I thinking right ?

[HPLC chemist]

It depends on your specification. Is the specification expressed as the trihydrate or the anhydrous molecule?

Typically, potency of the API in the drug product is determined in the clinical trials.

[Jowo]

Yes, it is expressed as anhydrous acid.

[koiseptember]

I agree with the purity equation posted by jarednathan which addresses HPLC impurities quantitated by area normalization.
But, I am wondering about HPLC impurities that may be quantitated by %w/w using a standard of their own.

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[Jahroll42]

There seems to be something wrong or misunderstanding.
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