Low Lactose ERP - Review Book

AOAC SMPR ERPs - 2019 METHOD REVIEW FORM

Submission Date

2019-09-08 15:32:38

Name

George Joseph

E-mail

george.joseph@asurequality.com

Organization

AsureQuality

Title of Method

Determination of Lactose in Low-Lactose or Lactose Free Milk, Milk Products, and Products Containing Dairy Ingredients

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

LAC-005

Applicable SMPR

2018.009

I. Summary of the Method

The quantification of lactose by ion chromatography with Inline Dialysis and pulsed amperometric detection. Samples are diluted with water and / or analyzed directly in liquids or diluted liquids orsolids treated with ultrapure water, using Inline Dialysis / Inline Sample Preparation. The sample preparation occurs during the analyses and does not add additional time to the analyses. Lactose in the samples is analysed with a recording time of 30 min. The concentration of lactose is determined by linear regression of the lactose in the standards compared to the lactose response of the samples as peak area. Carry over is minimized by automatic, nested rinsing steps, cleaning the full sample and dialysis path. The applicability of the method is not fully demonstrated by validation data to support the applicability of the AOAC SMPR 2018.009. The MUVA harmonization materials were used but no products containing dairy ingredients that are low-lactose or lactose-free were used. The recommended NIST SRM 2383a (Baby Food Composite) was not used but SRM 1869a (?) was included. The scope of the SMPR also includes “lactose- free” infant formulas and adult nutritionals but these matrices were not included in the validation. The SMPR states analytical method must account for potential interferences (see Table 1) in these matrices. This is partially demonstrated using allolactose, lactulose, glucose, galactose, sucrose, maltose and fructose on MUVA sample. Yes, the analytical technique meets the SMPR, however, it cannot be judged whether all performance characteristics meet the requirements, since the overview of system suitability parameters has not been given.

II. Review of the Method Only 1. Does the applicability of the method support the applicability of the SMPR? If not, please explain what is missing.

2. Does the analytical technique(s) used in the method meet the SMPR? If not, please specify how it differs from what is stated in the SMPR.