Journal
BIOLOGICAL & PHARMACEUTICAL BULLETIN
Volume 40, Issue 1, Pages 68-72Publisher
PHARMACEUTICAL SOC JAPAN
DOI: 10.1248/bpb.b16-00600
Keywords
microcrystalline cellulose; international specification; solubility; sodium hydroxide
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Funding
- Japanese Ministry of Health, Labour and Welfare
- Food Safety Commission
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Microcrystalline cellulose (MCC) is used globally as an inactive ingredient in food and nutraceutical products and is commonly used as a food additive. To confirm the conformity of MCC to the solubility requirements stipulated in international specifications, the solubilities of commercially available MCC products were tested in sodium hydroxide (NaOH) solution. All of the samples were insoluble in NaOH solution, which is inconsistent with the descriptions provided in international specifications. We also prepared celluloses with different degree of polymerization (DP) values by acid hydrolysis. Celluloses with lower DP were prepared using a three-step process, and their solubilities were tested in NaOH solution. These celluloses were found to be insoluble, which is inconsistent with the descriptions provided in international specifications. The present study suggests that the descriptions of the solubility of the celluloses in NaOH solution found in the current international specifications should be revised.
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