2018 Sugar ERP - Method Review Book

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. method performs within the SMPR Method Performance REquirements table specifications for all analytes in the SMPR applicability statement? If not, please specify what is missing and whether or not the method's applicability should be modified. 3. Is there information demonstrating that the

Yes, the precautions and warnings are well written.

The same terms as outlined in the SMPR are not used in the submission. Specifically the term reproducibility appears to be used for the repeatability data in the submission. Although the matrix terms (animal and pet foods, human food, ingredients) are not used consistently in the submission, the matrices included in the submission fit within the SMPR matrix categories.

NIST 1849a is the reference material listed in the SMPR that is included in the validation data. No additional reference materials (listed in the SMPR or not listed) are included in the submission.

Inclusion of additional reference materials would provide substantially more information on the method accuracy across a range of matrices.

The accuracy data is limited to lactose in 1849a (infant formula reference material). One of the three replicates is outside the established range as described in the submission. All other supporting data is related to the precision. The analytes meet the SMPR precision requirements except for glucose in yogurt and fructose in dry pet feed. The glucose in yogurt is below the specified LOQ in the SMPR (0.1%), therefore the higher %RSD is acceptable. The fructose %RSD in dry pet feed (9.68%), is above the 7% RSD limit in the SMPR. The matrix coverage does not fully support the scope of food as outlined in the method purpose section, since the matrix coverage does not fully address the requirements of section 7 (Validation Guidance) for coverage across the range of the AOAC food pyramid and matrix variations (high sugar versus high non- sugar carbohydrate content).

Potential interferences as listed in Table 2 of the SMPR are not fully addressed in the supporting data.

System suitability and analytical QC (section 6 of the SMPR)are not addressed in the method submission.