Low Lactose ERP - Review Book

AOAC SMPR ERPs - 2019 METHOD REVIEW FORM

Submission Date

2019-09-09 09:05:20

Name

Sookwang Lee

E-mail

Sookwang.lee@fda.hhs.gov

Organization

US FDA

Title of Method

Lactose, free and low, Profile by High Performance Anion Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD)

AOAC Candidate Method Number (e.g. ALN-01)

LAC-001

Applicable SMPR

SMPR 2018.009

I. Summary of the Method

SLV study of a HPAEC-PAD method for quantification of lactose, based upon IDF/WD244 and ISO /CD 22184. All the criteria within the SMPR2018.009 are appropriately addressed. The report excellently describes the lactose analysis in low-lactose and lactose- free milk products, which is challenging, partly because HPLC-RID is not sensitive enough, and the poor chromatogram baseline by IC in some samples (milk), among others. The reviewer couldn’t find the representative chromatograms for the real milk samples in the report. How was the baseline? This method chose the best option (No 3) for the lactose analysis in free-, or low- lactose milk products. 1) direct measurement (HPLC-RID?), 2) Indirect (?) measurement via reduction to the sugar alcohols, first, which will not be a problem in the most dairy products, but would be problematic in low lactose milk products and 3) Direct and indirect measurements via D-glucose (?) and comparing the differences.

Only drawback of this method is that there will not be many labs capable of running IC methods routinely.