The interesting points are highlighted in RED.
"Response to: Understanding steroid lab tests.
The above statement is incongruous with the response by the author. It would appear that in order to give it the title he did, he at least should have had some understanding himself of the facts. From my professional opinion he does not and so I would question any other theories he may have on any other subject."
The explanation given in the article refers to different analytical procedures.
Since our analytical process is aimed at detecting – not only the quantity but also the quality of the raw material (HPLC graph attached), Analytical procedures will measure the amount of active material of one gram of testing gradients, not one gram of ”powdered tablet”. In addition to this, we are also able to measure a third parameter - the biological activity of the sample. As quoted in the article:
..” The UGL claims the test found 128 mg of Anastrozole in 1 g of ground tablets and that each tablet weighed on average 0.100 g. Using those figures each
tablet should contain 128 * 0.100 = 12.8 mg per tablet. Yet the test claims exactly 1mg per tab ( coincidentally the quantity claimed on the products
label ) . I think we can safely assume based on the maths that this test is bogus. ”
…well this was the example that was supposed to demonstrate one awkward way of calculation!
And yet another example he proposed.
Fluoxymesterone: Now look at the differences of the three dimensional HPLC UV DETECTOR- we had to under- dose the preparation by definition to achieve the proper target dosing.
Allow me to Explain these:
For certain products, in this particular industry, the supply of raw materials is not consistent. We must therefore adjust the biological activity with the dosage form to reach optimal end product. Just because no other lab in our industry is following these protocols does not mean it’s ok. You are likely to get under dosed product from them. Our product is tested at our GMP lab before and during production; and post production independently by another lab whose results we post. Our results are accurate and the product quality speaks for itself.
Back to the above quote: This does not relate to a proper HPLC procedure of analyzing by UV Detector which allows our lab to adjust the two curves created during the Sample/Standard analysis to the proper unit dose as determined by the protocol of production.
The suggestion that the mg/g factor is a simple mathematical division between the average weight of the tablets and the final amount of active(s) in the final tablet is a complete misunderstanding of analytical procedures and shows the lack of understanding by the author of that article. It is sad that the author who claims to have knowledge in this area obviously has very little (just enough to perplex everyone) and as a result ends up confusing the readers with his speculations.
Just a short explanation of the procedure:
The sample to be analyzed is introduced in small volume to the stream of mobile phase. The analyte's motion through the column is slowed by specific chemical or physical interactions with the stationary phase as it traverses (passes through) the length of the column. The amount of retardation depends on the nature of the analyte, stationary phase and mobile phase composition. The time at which a specific analyte elutes (comes out of the end of the column) is called the retention time; the retention time under particular conditions is considered a reasonably unique identifying characteristic of a given analyte. The use of smaller particle size column packing (which creates higher backpressure) increases the linear velocity(speed) giving the components less time to diffuse within the column, leading to improved resolution in the resulting chromatogram. Common solvents used include any miscible combination of wateror various organic liquids (the most common are methanoland acetonitrile. Water may contain buffers or salts to assist in the separation of the analyte components, or compounds such as trifluoroacetic acid which acts as an ion pairing agent.
Any professional will be able to identify the parallel results between the Standards and our samples – the graphs are the ultimate proof in the sample analyses and the numbers are not just “mathematical divisions as numbers can be “adjusted” but are backed up by the Chromatographic graph from the HPLC-MS-UV. See below
Project name: Fluoxymesterone TV7R53
(See attached file)
---- Sample Name STD Fluoxymesterone vial 02 Date acquired 02/01/2009 8:00 am Channel Name 310 nm Sample Weight 0.001 dilution 20,00000
---- Sample Name 001 Fluoxymesterone vial 89 Date acquired 02/01/2009 8:00 am Channel Name 310 nm Sample Weight 0.02 dilution 10,00000
I find it irresponsible by the author to use terms that seem to the layperson as solid scientific facts while they are not. I, as a scientist find it very cumbersome to have to explain and re-explain facts that are so simple to observe from our HPLC- UV detector graphs. As the chief scientist I am here to help our clientele with advice know-how and new innovations. If I were a betting man I would bet that the author was trying to ride the back of Axiolabs by putting out false data in an attempt to get his site known through the ensuing drama.
I love my work and I love serving you. We are not here to quarrel, waste our valuable time or open a scientific war on facts that have existed for almost half a century.
For any further information about our process please refer to the following reference material :
Handbook of HPLC
By Elena Katz
Edition: 2
Published by CRC Press, 2002
ISBN 0824794443, 9780824794446
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