Analysis of illegal peptide biopharmaceuticals frequently encountered by controlling agencies

The occurrence of putative cognitive enhancing research peptides in seized pharmaceutical preparations: An incentive for controlling agencies to prepare for future encounters of the kind

“…A 10 × dilution of these solutions was made in water and formic acid was added to a final concentration of 1%. Next, the samples were subjected to centrifugation for 15 minutes at 20238 × g in a micro centrifuge prior to analysis by means of either our standard LC–MS n methodology or the newly developed HRAM LC‐MS/MS methodology (see further).…”

“…At the end of 2017, an unknown unlabeled pharmaceutical preparation was submitted by the FAMHP for analysis by means of liquid chromatography–tandem mass spectrometry (LC–MSn). Based on the interpretation of the LC–MSn data, we were not able to identify this substance as being one of these “classical” peptides described in the plethora of case reports or present in our in‐house library . Further analysis by full scan high‐resolution, accurate‐mass (HRAM) MS/MS combined with a newly developed LC gradient, applicable to both hydrophobic and hydrophilic peptides, de novo peptide sequencing, digestion by specific proteases, and final confirmation by custom synthesized reference standard showed that the substance present in the sample corresponded to a polypeptide with sequence TKPRPGP, known as Selank .…”

Substandard and falsified antimicrobials: A potential biohazard in disguise?

“…2 The past decade has been marked with numerous actions that were taken to prevent SF medical products from infiltrating legal supply chains. [5][6][7][8][9][10] The majority of these analytical findings is focused on the chemical characterization, i.e. This directive provides a preventive system for falsified medicines, e.g.…”

Are injectable illegal polypeptide drugs safe? Case report demonstrating the presence of haemolytic Bacillus cereus in 2 illegal peptide drugs

“…The danger of these illegal polypeptides resides in the fact that these peptide products are not produced under controlled environment. Therefore, these products may not only contain the wrong ingredient the wrong dosage, and chemical impurities encompassing related synthesis and degradation compounds, heavy metals, residual solvents, and metabolic products from dead microorganisms, but they could also contain spores and living microorganisms. Upon injection, these microorganisms could result in severe health issues as has been reported for contaminated injection syringes .…”