Low Lactose ERP - Review Book

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. 3. Are the definitions specified in the SMPR used and applied appropriately in the method? If no, please indicate how the terms are used. 4. Does the method, as written, contain all appropriate precautions and warnings related to the method's reagents, components, instrumentation, or method steps that may be hazardous? If no, please suggest wording or option(s). III. Review of Supporting Information 1. Are the definitions specified in the SMPR used and applied appropriately in the supporting documentation (manuscripts, method studies, etc...)? If not, please explain the differences and if the method is impacted by the difference. 2. Is there information demonstrating that the method meets the SMPR Method Performance Requirements using the Reference Materials stated in the SMPR? If not, then specify what is missing and how this impacts demonstration of performance of the method.

Yes, but with one caveat. For liquid samples the calculations give mg/100ml where the method specifies mg/100g. This will require a few slight edits to the method but it is not substantial.

Yes.

Yes.

Yes.

Yes, with one exception. There is a note in the report and is reflected in the data that the method did not work well for sodium caseinate, MUVA CA 0904, and the recovery was significantly lower than the method performance requirement. The method authors attribute this to the low solubility of sodium caseinate using the reagents in this method. Also note that there is not information about the repeatability of the method near the high end of the analytical range (near 2000 mg/100g), They have demonstrated this in the low end of the range ~150 mg/100g.