Quality of a finished product should be the #1 concern of all manufacturers – and of all consumers. This is especially true in using peptides as therapeutic agents. Lower quality peptides can contain “fillers” like mannitol or contain impurities, which limit their effectiveness as therapeutic agents, reduce the effectiveness of our treatments as clinicians, AND place the patient at risk for possible adverse reactions or unwanted side effects. Unlike peptides synthesized in many other parts of the world, American-made peptides subject to rigorous and uncompromising manufacturing processes finely tuned to produce the most pure, highest quality peptides.
The International Peptide Society (IPS) recommends using only the highest purity peptides (>99% pure) for use. Pharmacies in the US that manufacture peptides follow strict guidelines for synthesizing, purifying and analyzing the final product. Using less than 99% purity means that some of the peptide fragments are not binding to the receptors – in fact we have no idea what these fragments are doing, making PURITY the #1 concern.
A recent NY Times article reported that “The head of Switzerland’s anti-doping organization told me that his agency’s tests have shown that 80 percent of the peptides advertised on the web are adulterated or outright fakes”.
Peptide purity is usually determined using a combination of mass spectroscopy and HPLC (high pressure liquid chromatography), with HPLC being the most universally used method in quality control of peptides.
Mass spectroscopy characterizes the peptide’s mono-isotopic mass (the mass of the isotopic peak whose elemental composition is made of the most abundant isotopes of those elements).
The accuracy of this determination should be greater than + 1 mass unit. Only instrumentation that is capable of determining this resolution should be used when analyzing peptides for quality control.
Mass spectroscopy can also be used to confirm the sequence of the amino acids in the peptide.
What is HPLC (High Performance Liquid Chromatography)?
HPLC is a technique in analytic chemistry used to separate, identify, and to quantify each component in a mixture.
HPLC uses high-pressure solvent to force the sample in question through a column using chromatography to separate the results. HPLC is extremely sensitive when it comes to analyzing what is in the sample.
Again, look for 99% purity with no impurity greater than 1% and MADE IN THE USA. Other countries that make peptides may not follow US guidelines. It is important to know where your peptides come from.
Are they made in GMP (Good Manufacturing Practice) approved facilities following strict quality control guidelines?
Thanks to the IPS for this blog post!
Powell, Michael. “At the Heart of a Vast Doping Network, and Alias.” NY Times, March 26, 2018. ↑