December 17, 2024, 01:58:35 PM
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Topic: Qual/Quantitative testing process for pill/medicine/supplement ingredients  (Read 2349 times)

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Offline RogueRose

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I'm helping do research for a project where one aspect requires the testing of both prescription and OTC pharmaceuticals and supplements.  The testing process needs to be able to identify the components of the pill/medicine/supplement as well as how much of the ingredient is in the sample.. 

The problem I'm seeing is that many pills have fillers/binders/matrix ingredients which really aren't the focus of the testing but the information would probably prove helpful in many instances so identifying them as far as what they are may be important but how much or what the concentration is wouldn't be so important. 

I've read about a number of different testing procedures like GCMS, LCMS, HPLC, etc but don't know enough about them to say which would be the proper testing platform for the kind of work required. If there are any other analysis processes which would be useful, newer or older, I would like to hear opinions of those as well.  I don't know what the different chromatography processes will test for so any explanation as to which could be used for what purpose, that would be super helpful.

 I don't need detailed explanations as this is the initial data dig on the subject to basically construct an outline for the project and point further research in the proper direction and not waste time in areas which won't work or be helpful. 

Offline marquis

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A good starting point is to check the regulatory methods used to test your products.  For example, if you are in the US, see how the USP tests the active ingredients.  Then try and develop your methods around these tests. 

Most OTC are still required to meet Fda requirements, which means validation.  Validation can be tedious.  Often, you can cut down on a step or two by using a previously recognized and approved method.

Having said that, hplc and GC are very common for quant work.  For identity, IR is most common, although I like EDXRF better for mineral fillers.

Consider gcms.  It is more expensive and easier to contaminate.  But when trying to ID an unknown in a liquid, it is hard to argue with gcms results ( with a good library and the right software).  A regular gc- say GC/fid will be much less expensive.

LCMS is good, but more expensive than gcms.  It takes more training, also.

My thoughts.  There are many others on this forum with more experience. 

Good luck.

Offline marquis

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Many of your inactive ingredients will also need to be tested to specific USP monographs.  Look over these monographs and see what equipment is required for each ingredient, as well.  It could help select appropriate methods.

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