Phospholipid Analysis for Responsible Quality Control

 

As PS and other phospholipids have become increasingly popular, demands for quality control and the analytical requirements to support it grew very fast and finally they have created a lot of confusion and irritation. One can present a PS product sample to 5 different commercial labs for analysis and get back 5 very different results and  none of which makes sense.

 

We have tested several labs and found that even very reputable labs cannot get accurate data on PS content with their existing equipment and method, and may completely fail to detect certain phospholipids. This is an extremely critical situation for responsible product manufacturers who want to conform to regulatory requirements and guarantee 100% potency in their finished products.

 

The most commonly used testing uses HPLC (high pressure liquid chromatography), but poorly validated methods, buildup of PS-material in the column, inappropriate standards and many other factors make it hard and almost impossible for HPLC to give reliable results for phospholipids, particularly in finished products with more than one ingredient.

 

We have submitted test samples to labs and got back results that state certain phospholipids are absent from the sample. Using a test product containing 100 mg PS we have got back results that range plus and minus about 35 percent. Many labs don't even want to acknowledge anomalous findings and simply insist that their analysis is the only correct one. So, where and who is the referee?

 

It is called 31P-NMR (31Phosphorous Nuclear Magnetic Resonance). This method generates extremely accurate data based on the resonance behavior of the phospholipid phosphorus in a magnetic field. Among phospholipid experts and academic labs around the world, the consensus is that 31P-NMR is the "gold standard" for phospholipid analysis, including for PS.

 

From our extensive experience with analytical testing of phospholipid products, which dates back to the 1980ieths , we have evaluated and eliminated a number of parameters that might contribute to inaccurate results. We also came to the conclusion that 31P-NMR is the most precise method available today. This one method detects and quantifies all the phospholipids in any type of matrix, and is not vulnerable to contamination, manipulation of complex test standards, and other problems that plague HPLC.

 

Our conclusion is, if any lab with their available method gets an analytical result that does not match 31Phosphorus Nuclear Magnetic Resonance, their results are wrong!

 

The sophisticated equipment for 31P-NMR analysis is very expensive and not widely available. However the analysis is not costly. For help getting your sample analyzed by an independent laboratory using 31P-NMR, feel free to contact us.

 

 

 

 

 

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