The recent issues with levothyroxine products that contain mannitol (that from Merck and also at least the UK-version of Teva's levothyroxine) is interesting and deeply concerning.
I noticed mention in the French thyroid websites of the presence of nanoparticles of nickel and of aluminium - which is still in question.
Made me do a little bit of searching and I found the paper below.
Seems that one process for making mannitol relies on precisely those substances - nickel nanoparticles and aluminium (as hydroxide). Which leads me to suggest these substances could be found as impurities in the mannitol itself.
We rarely have any insight into the suppliers of excipients (ingredients other than the active pharmaceutical ingredient(s)). Not knowing where is was made, whether the supplies are always from the same sources, or anything else. So it is very difficult for us to get any further.
Effective Production of Sorbitol and Mannitol from Sugars Catalyzed by Ni Nanoparticles Supported on Aluminium Hydroxide
R. Rodiansono 1*, Shogo Shimazu21 Department of Chemistry, Lambung Mangkurat University, Jl. A. Yani Km 36.0 Banjarbaru, South Kalimantan, Indonesia2 Graduate School of Engineering, Chiba University, 1-33 Yayoi, Inage, Chiba 263-8522, Japan
Received: 21st December 2012; Revised: 7th February 2013; Accepted: 10th February 2013
Abstract Effective production of hexitols (sorbitol and mannitol) was achieved from sugars by means of nickel nano-particles supported on aluminium hydroxide (NiNPs/AlOH) catalyst. NiNPs/AlOH catalyst was prepared by a simple and benign environmentally procedure using less amount of sodium hydroxide. ICP-AES and XRD analyses confirmed that the NiNPs/AlOH catalysts comprised a large amount of remained aluminium hy-droxide (i.e. bayerite and gibbsite). The presence of aluminium hydroxide caused a high dispersion Ni metal species. The average Ni crystallite sizes that derived from the Scherrer`s equation for former R-Ni and NiNPs/AlOH were 8.6 nm and 4.1 nm, respectively. The catalyst exhibited high activity and selectivity both hydrogenolysis of disaccharides (sucrose and cellobiose) and monosaccharides (glucose, fructose, and xylose) at 403 K for 24 h. The NiNPs/AlOH catalyst was found to be reusable for at least five consecutive runs without any significant loss of activity and selectivity. © 2013 BCREC UNDIP. All rights reserved
Keywords: supported-nickel nanoparticles; hydrogenation; sugar; sorbitol; mannitol
How to Cite: Rodiansono, R., Shimazu, S. (2013). Effective Production of Sorbitol and Mannitol from Sugars Catalyzed by Ni Nanoparticles Supported on Aluminium Hydroxide. Bulletin of Chemical Reaction Engineering & Catalysis, 8 (1): 40-46. (doi:10.9767/bcrec.8.1.4290.40-46)