Early Input Sought on Proposed Isomaltooligosaccharides Monograph
USP is requesting early input from stakeholders on a new monograph for Isomaltooligosaccharides (IMO) which is being considered for publication in the Food Chemical Codex (FCC). The proposed Isomaltooligosaccharides monograph is based in part on the China National Food Standard GB/T 20881-2007 for IMO, as well as data and information received from sponsors. USP also intends to develop a new reference standard, USP Isomaltooligosaccharides System Suitability RS, for use with this new monograph.
Below is a list of tests or specifications that are proposed for inclusion in the FCC monograph, which are not included in the current China National Food Standard GB/T 20881-200 for IMO. Comments and feedback are welcome concerning these tests and specifications.
- An IC-PAD method is proposed for Identification, Assay, and the Glucose and Maltose impurity test, as well as Glucose Content after Hydrolysis
- The proposed specification for Isomaltose, Isomaltrotriose, and Panose Content is based on commercial sample testing results which had a mean and standard deviation of 42 and 12, respectively, calculated on the anhydrous basis. This specification is different from the GB standard of NLT 35 for IMO-50 and NLT 45 for IMO-90.
- Specifications for Glucose and Maltose limits are proposed using data and information received, in which 3 of 12 samples had glucose content higher than the limit, and 4 of 12 samples had maltose content higher than the limit.
- Specifications for Glucose Content after Hydrolysis and Water are based on testing data of commercial sample analysis.
- Specifications for Arsenic and Lead limits, and Residue on Ignition (Sulfated Ash) are proposed, based on published available data on commercial products
- USP Isomaltooligosaccharides System Suitability RS dominant in Isomaltose, Isomaltrotriose, and Panose is proposed for ensuring system suitability.
Currently, the proposed monograph is targeted for publication in the December FCC Forum. In addition to publication in the FCC Forum, USP would like to further engage stakeholders to identify and discuss the potential impact of this proposed monograph on the food ingredients industry. In order to accomplish this objective, USP welcomes interested stakeholders to provide preliminary feedback on this proposed monograph and the proposed USP Isomaltooligosaccharides System Suitability RS prior to its publication in the FCC Forum.