2018 Sugar ERP - Method Review Book

3. Is there information demonstrating that the

Method performance for Lactose and Sucrose could be challenging as it does not pass the RM range (%) for the CRM - BCR-644 - Artificial foodstuff.

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. IV. General Submission Package 1. Based on the supporting information, were there any additional steps in the evaluation of the method that indicated the need for any additional precautionary statements in the method? 2. Does the method contain system suitability tests or controls as specified by the SMPR? If not, please indicate if there is a need for such tests or controls and which ones. 3. Is there information demonstrating that the method system suitability tests and controls as specified in the SMPR worked appropriately and as expected? If no, please specify.

It may be worth to look at the applicability and acceptance criteria based on the sample matrix - Protein/Sugar contents.

Method author can segregate the tested food matrices based on the three different sample preparation procedure in this method and a suitable acceptance criteria can be discussed for each category. Also, need to review the chromatograms of the following sample matrix spiked at LOD level, and their overlay with native samples, to make sure there are no critical pairs to be concerned or to rule out the gradient background influence: Peanut Butter , Lemon Juice, Ham, Salami, Turkey, Mince, Gummy, Premix, Protein powder drink, Dry Dog Food, Dry Cat Food, Wet Cat food, Horse Feed, Swine Feed, Milk Replacer Usage of sodium azide as stabilizer and the associated safety aspects needs to be revised by the safety committee; if acceptable by the safety committee, suitable handling precaution and suggestion can be included in the method

Specificity with respect to the interference listed in AOAC SMPR needs to be adequately addressed.

System suitability/Analytical quality control as per SMPR section 6 is well addressed in the method section I.

Yes they are well addressed. The detector system uses, Ag/AgCl electrode - how frequently the electrode needs to be filled with electrolyte? - if known can be included in the method Gold electrode losses its sensitivity - especially when used with complex food matrices. Is there any quality check for the electrode performance based on the internal standard or calibration standard area? - if available can be included in the method during validation does the method validated for Robustness - what is the influence of 5-10% variation in temperature, eluent concentration & flow rate on selectivity?

4. Based on the supporting information, is the method written clearly and concisely? If no, please specify the needed revisions.

It is one large method that tries to address various sample matrices. It is very difficult to follow the method flow and the validation criteria's.

For the benefit of standard users, there could be three sub section based on sample type and sample preparation G1,G2,G3. This will also help to narrow down the acceptable accuracy and precision criteria for each sub segments.