Molecular Isotope Technologies LLC ℠ (MIT LLC) specializes in Product and Process Authentication (Nature's Fingerprint® authentication) for the pharmaceutical and chemical industries via natural, ambient tracers. After 18 years as an organic and stable-isotope chemist, Dr. John P. Jasper observed that natural stable-isotopic composition was going virtually unused in the synthetic chemical industries.
In 2000, MIT LLC performed a preliminary study on the composition of over-the-counter analgesics (pain killers) indicated that there were very large tracer variations in these common drugs. They were "very large" (i.e., easily measurable) at the trace level, but were so small that they would have no measurable effect on the drugs' efficacy. At about this time, the U.S. Food and Drug Agency (FDA) took note of this research and instituted a number of studies with MIT LLC on the potential tracer variations in Active Pharmaceutical Ingredients (APIs).
In all cases, important stable-isotopic differences ("fingerprints") from one batch of product to another were noted, then differences between one manufacturer and another of the same API. Pharmaceutical scientists became interested in MIT LLC's work in Product Authentication and began to ask about the mechanism(s) of this batch-to-batch and manufacturer-to-manufacturer differentiation in pharmaceutical components.
In early 2003, these questions led to the development of the area of Process Authentication, differentiating the effects isotopic composition of raw materials and reaction steps in what has become known as Isotopic Pedigree® authentication of synthetic pathways. These techniques of Product Authentication are presently being employed in the pharmaceutical industry for purposes of Process Patent Protection and for Process Consistency.