ohje, do we really trust pharma products and analysis???

Off-topic conversations and chit-chat.

10 posts Page 1 of 1
Quote from the box of phenoxymethylpenicillin that my child is taking:
"Total Sodium content per 5mL is 0.005mM"

I barely know where to start. Not only have we got the fundamental "mMolar versus mmole" problem that you'd hope would be ironed out by the end of a masters in analytical chemistry, or a degree in pharmacology. But on top of that I wonder if we've got a problem with our orders of magnitude? The medication contains sodium saccharin and sodium benzoate as preservative.
It certainly makes you wonder. Leaving aside the dubious quality of the result, there is something bizarre about stating the sodium content of a medicine - does anyone rally take enough drugs for the sodium to give them high blood pressure ?. It reminds me of a heated internet discussion about the dreadful risks of being sprayed with pyrthethroid on international flights, as if being in a metal tube 10 km above the ground wasn't risky enough already.

Peter
Peter Apps
lmh wrote:
Quote from the box of phenoxymethylpenicillin that my child is taking:
"Total Sodium content per 5mL is 0.005mM"

I barely know where to start. Not only have we got the fundamental "mMolar versus mmole" problem that you'd hope would be ironed out by the end of a masters in analytical chemistry, or a degree in pharmacology. But on top of that I wonder if we've got a problem with our orders of magnitude? The medication contains sodium saccharin and sodium benzoate as preservative.


That would be 0.115g/L of Sodium from the preservatives. So sodium benzoate is present at about 0.05% which seems a little low actually as a preservative and that is not counting the saccharin contribution.

Also that is only 575 micrograms in a 5ml dose, is that amount of sodium even something to be considered as Peter said.

I guess though as is mandated by the FDA now, if you put any sodium at all into the product, you must label it with the content. But the average person is definitely not going to know what mM units mean at all. :roll:
The past is there to guide us into the future, not to dwell in.
I'm really confused about what they actually meant. 0.005mM clearly makes no sense (5uM total counter-ion for both the sweetener and the preservative??)

But even if they meant 0.005 mmoles in 5mL, that actually gives an even lower estimate of sodium benzoate than the one you arrived at, questionably enough for it to preserve anything (and we're still ignoring the saccharin).

Yes, the amount of salt present should be piddlingly small and irrelevant to health, but specifications of pharmaceuticals really ought to be vaguely correct and clear enough to be half-way meaningful. What really scares me is whether the same person calculated the amount of active ingredient to put in the bottle...
What scares me even more are the number of very basic questions that pop up here about analysing drugs for QC.

Peter
Peter Apps
Peter Apps wrote:
What scares me even more are the number of very basic questions that pop up here about analysing drugs for QC.

Peter


Even worse are some of the official methods I have seen for doing those analyses.

Until about two years ago the accepted method for analyzing for heavy metals in pharmaceuticals by USP was a spectrophotometric method, and it was widely known that 5 of the 10 metals analyzed for gave no absorbance at all. So you could pass the test and be loaded with any of those metals and never know it.
The past is there to guide us into the future, not to dwell in.
James_Ball wrote:
Peter Apps wrote:
What scares me even more are the number of very basic questions that pop up here about analysing drugs for QC.

Peter


Even worse are some of the official methods I have seen for doing those analyses...



Agree with Peter and James.

And I'm recently "amazed" at the poor quality of two test procedures from a large European company that one might think has its "stuff" together.....
There are just a lot of methods in general that are accepted as Official and "well established and standardized that franky are anywhere from mediocre to idiotic. I mentioned on another thread the USP 3-monochloropropane diol method. A lot of the AOAC methods and methods in general are needlessly large scale or waste too much solvent (AOAC BHA/BHT). I think the analytical community needs to make a stronger push to purge these bad or outdated methods.

As for calculation problems after I started my current job I had to fix a method my company had been using for nearly a decade because someone thought when you take 3g of sample and 9g of water you have a dilution factor of 3 fold and also when you pippette 5 ml of this (very dense high salt solution with no ITSD to compensate for the calc error) you are taking exactly 5/9.

A lot of companies have been cheaping out on their analytical staff by staffing them with temps for $15 USD an hour and frankly they are getting what they pay for.
MSCHemist wrote:
There are just a lot of methods in general that are accepted as Official and "well established and standardized that franky are anywhere from mediocre to idiotic. I mentioned on another thread the USP 3-monochloropropane diol method. A lot of the AOAC methods and methods in general are needlessly large scale or waste too much solvent (AOAC BHA/BHT). I think the analytical community needs to make a stronger push to purge these bad or outdated methods.


Agree.


MSCHemist wrote:
As for calculation problems after I started my current job I had to fix a method my company had been using for nearly a decade because someone thought when you take 3g of sample and 9g of water you have a dilution factor of 3 fold and also when you pippette 5 ml of this (very dense high salt solution with no ITSD to compensate for the calc error) you are taking exactly.


Not uncommon. Akin to diluting too much then complaining that analyte is on tail of solvent peak.


MSCHemist wrote:
A lot of companies have been cheaping out on their analytical staff by staffing them with temps for $15 USD an hour and frankly they are getting what they pay for.


Agree.
Surely the whole idea of the criticality of active ingredient measurment in the pharma industry is a bit nonsensical anyway. A drug is produced with analysis with a very low level of variance on the active measurement and is then administered by a doctor taking little or no account for the patients weight and body fat levels.

Just glad I don't work in a GLP/GMP/Pharma setting!!

GCguy
GCguy
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