Low Lactose ERP - Review Book

5. Based on the supporting information, what are the pros/strengths of the method?

Selective for lactose with a few known interferences that may bias results but are clearly listed in the method. Interferences may be detected by using a internal standard.

Allows for high throughput of materials since many samples can be run simultaneously.

This technique may be easily run in locations that have no access to chromatographic methods.

Can be done by technicians with minimal training since there is no complex instrumentation

6. Based on the supporting information, what are the cons/weaknesses of the method?

The method needs refinement for materials with poor solubility in the current reagents so that it can be applicable for use for all materials in the SMPR (i.e. sodium caseinate)

Users must be diligent to account for interfering materials that may be present.

One of the strengths of this method is also its weakness. Since it can be done by technicians with little training, there may be potential issues that can be overlooked or ignored because the operator is not familiar with the limitations of this type of method.

7. Any general comments about the method?

There is a statically significant difference between analysts in 4 out of 7 of the repeatability measurements listed in tables 7 thru 13. While these differences are within the performance requirements of the SMPR for repeatability, it is worth noting this could be a potential issue especially with persons not experienced with enzymatic assays. The method is suitable to be adopted as a First Action, with appropriate updates and changes as noted above. This method does demonstrate that it is capable of determining lactose within the performance requirements of the SMPR based on single laboratory results with multiple analysts. While there are a few minor issues with the method as is, the methodology is sound and generally robust.

V. Final Recommendation Do you recommend this method be adopted as a First Action and published in the Official Methods of Analysis of AOAC INTERNATIONAL? Please specify rationale.