R-LIPOIC ACID & SALTS… BUYER BEWARE
Price is not the bottom line & is no guarantee of quality when it comes to R-Lipoic Acid containing products!
Numerous R-Lipoic Acid containing products have appeared on the market in the last few years. We discovered a wide range of problems associated with many of these products including:
Hands On Experience
GeroNova Research, Inc has been researching, developing, producing and offering R-Lipoic Acid and related products to researchers and industry since 1998. During this time we have learned how to manufacture and analyze this fascinating molecule and have solved problems that other companies have chosen to "overlook"; passing off low quality products to unsuspecting supplement manufacturers, suppliers and the general public.
The Latest Fraudulent Products… R-Lipoic Acid Salts
Due to the great success of our R-Lipoic Acid products (sodium R-Lipoate and potassium R-Lipoate) and our published pharmacokinetic studies, (see below) several Chinese companies have been actively soliciting us and our customers with inexpensive "R-Lipoic Acid salts". Apparently these companies have made the assumption that naïve American consumers are only concerned with the bottom line and that they could sell their fraudulent products without being detected.
Samples from China
The first sample we obtained, from Nanjing Gemsen International (NGI) was represented as containing 86.5 % R-Lipoic Acid, (View the C of A) but our assay using the USP method showed it contained only 30.9% total Lipoic Acid. We later determined by chiral HPLC (View validated chiral method) that at least it did contain R-Lipoic Acid. Representatives of NGI claim to have sold this product to both Japanese and European clients who accepted the assay values. If this is true, what brand of supplements did this stuff end up in? The sample was tan colored, contained hair, dirt and other unidentified impurities.
Brokers and laboratories in the US
The most recent attempt to launch an inferior sodium R-lipoate product into the US supplement market was from an American broker acting as a representative of an unidentified Chinese manufacturer, allegedly specializing in chiral chemistry. The sample was represented by the manufacturer as containing 72% R-Lipoic Acid and an independent analysis from a US commercial laboratory claimed it contained 799.62 mg/g or 79.96 % R-Lipoic Acid. The sample had the texture of talcum powder but it had a foul odor, uncharacteristic of the genuine product.
The broker claimed "This sample is 72% R-Lipoic Acid load as per the COA of course, not >85%, though as stated >85% is not a problem to produce. I would highly doubt the true % will ever fail to be below 85% assay." We have been trying for years to get the load of R-Lipoic Acid higher than 85% so we were intrigued by his bold/confident claims. While it is possible on a bench scale it has so far not been possible on a production scale (100 kg/batch).
We received a sample and after dissolving a 25 mg portion in water and analyzing it on the polarimeter, we knew within minutes it contained either racemic Lipoic Acid or contained a very small amount of R-Lipoic Acid, since the [a]D25 =+ 5 deg whereas the 70% material has a specific rotation of + 70 deg.
Subsequent analysis by the USP HPLC method revealed it contained 36.6% total Lipoic Acid, and chiral HPLC (View validated chiral method) revealed that the product was in fact racemic Lipoic Acid as we first suspected from our polarimetry readings.
Fake "Italian" R-Lipoic Acid
A large east coast nutraceutical distributor was offering "Italian" made R-Lipoic Acid for $185.00/kg. As soon as we heard about this we requested a sample and phoned our contacts at Labochem and Antibioticos, the top Italian manufacturers of lipoic acid, who said it was not their product and doubted the material was genuine. We ran a chiral HPLC analysis and verified it was racemic lipoic acid. We contacted the distributor who admitted it had been offered to them through a Chinese broker who claimed it had been made by an Italian manufacturer. They withdrew it from the market but we subsequently saw it being offered by them periodically as "Italian" made R-Lipoic Acid. We wonder how much of this material was ultimately sold to unsuspecting companies who accepted the manufacturer's certificate of analysis.
GeroNova Research, Inc. is building name recognition and is proud to be setting the industry standards for R-lipoic acid analysis and products. Your purchase of GeroNova's products supports cutting-edge research and product development.
Read about our In-House ResearchFor independent analysis (both chiral and USP methods) please contact Dr. Anthony Smith at smitha@smithscientific.net