A client recently approached RJ Lee Group with a suspected counterfeit version of their patented injectable medication. Unlike the cloudy solution the company produces, the two samples provided were more translucent, almost clear. The client was concerned that the samples were either a counterfeit or contaminated version of their product, and asked our laboratory to provide an elemental composition of the liquid. This case study discusses the first phase of testing.
Our Biotechnology and Pharmaceutical Services scientists conducted blind testing for harmful contaminants and other substances inconsistent with medical usage. First, drops from the vials were placed on glass slides and allowed to dry. The dried droplets were then put into a Scanning Electron Microscope (SEM), where scientists saw abnormalities in the samples’ surface particulate that were determined to be mercury-rich regions. They also noticed elemental composition variance amongst certain elements present in the drug. The peak response, which indicates the relative percent composition of the elements found within the drug, was higher and lower than expected for certain elements. This suggested the possibility that the drugs were diluted, or that additional ingredients had been added to mask abnormal contaminants.
Next, Inductively Coupled Plasma (ICP) testing was conducted for the detection of seven abnormal substances, which all came back below our detection levels. As a result of the SEM/EDS findings, scientists believed mercury could be one of the contaminants in the samples. However, mercury is unstable and volatile when tested using ICP, which can affect the precision and accuracy of the results as well as the instrument’s sensitivity. Consequently, the scientists decided to perform a third type of test for mercury, using Cold Vapor Atomic Absorption. Mercury was detected in the samples.
Further elemental analysis will be conducted on the client’s approved lots of medication, which will be compared to the suspect material for inconsistencies. Phase II of this testing will be discussed in a future Case Study.