Chemical fingerprinting of silicone-based breast implants.

With millions of women worldwide carrying them, silicone-based breast implants represent a large market. Even though silicone breast implants already have a history of use of more than 50 years, the discussion on their safety has not yet come to an end. To improve safety assessment, regulatory authorities should have the availability of a set of tests to be able to determine parameters of implant identity and quality. Therefore, the gels and envelopes of various brands and types of silicone-based breast implants have been subjected to infrared, Raman and NMR spectroscopy. We show that by using a combination of complementary spectroscopic techniques breast implants of various origins can be distinguished on typical chemical hallmarks. It was found that typical silicone-based implants display a surplus of vinyl signals in the gel, cyclosiloxane impurities are tolerable at low levels only and a barrier layer is present in the implant envelope. The techniques presented here and the results obtained offer a good starting point for market surveillance studies.

Capsule shells adulterated with tadalafil.

Following a health complaint a food supplement was brought in for analysis on the suspicion of being adulterated with a synthetic drug substance. When the capsule content did not show evidence of adulteration, the capsule shell was investigated. Using HPLC-DAD and HPLC-MS the capsule shell was found to contain 2.85 mg of the erectile dysfunction drug tadalafil. Using microscopy and RAMAN spectroscopy the presence of tadalafil was shown throughout the gelatine matrix as particles and dissolved into the matrix. The adulteration is probably carried out by adding tadalafil powder to a gelatine jelly in the manufacturing of the capsules shells. Because this technique may also be used for other drug substances, capsules shells should be considered a vehicle for hiding drug substances in general.