SMPR202018_009.pdf (aoac.org)

This document outlines AOAC SMPR 2018.009, standard method performance requirements for lactose analysis in low-lactose or lactose-free milk and dairy products.

Key Points:

Purpose: Provides minimum recommended characteristics for methods used to confirm compliance with regulatory standards for lactose content.
Applicability: Focuses on infant formula, adult nutritionals, and other dairy products marketed as low-lactose or lactose-free.
Analytical Techniques: Any valid technique meeting the outlined performance requirements is acceptable.
Definitions:
Lactose: β-D-galactopyranosyl-(1→4)-D-glucose (CAS No. 63-42-3)
Limit of Detection (LOD): Lowest concentration distinguishable from a blank sample.
Limit of Quantitation (LOQ): Lowest measurable level with specified precision.
Method Performance Requirements:

Range: 5-100 mg/100 g for general dairy products, 10-100 mg/100 g for infant formula, and >100-2000 mg/100 g for specific products.
Recovery: 85-115% for most samples, 90-110% for infant formula.
Repeatability & Reproducibility: ≤10% RSDr and ≤15% RSDR for general dairy products; stricter limits for infant formula.
System Suitability Tests/Quality Control: Include blanks and appropriate check standards.
Validation: Recommended level is AOAC Official Methods of AnalysisSM.
Reference & Harmonization Materials: Lists NIST SRM 2383a (baby food composite) as a reference material and provides links to external sources for harmonized materials from National Milk Laboratories (UK) and MUVA (Germany).