Low Lactose ERP - Review Book

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. 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? 3. Is there information demonstrating that the

Yes. LOD, Accuracy, Recovery, Repeatability, among others are well defined and explained properly.

Yes.

Per Table 2 of SMPR, 3 different ranges of lactose contents are specified. The results from LAC-001 demonstrates that the method performances were satisfactory in all 3 analytical ranges, 4 samples for the lower range of lactose content, 5 samples for the mid-range (10 ~ 100 mg/100g) and 4 samples for the higher range. The focus of this method should be on low level of lactose, i.e., around 10 mg/100g. The report shows that the method LAC-001 performs well in that range of lactose content. Table 3 in SMPR states the NIST SRM2383a (baby food composite), which is not found in LAC-001. Two CRMs of MUVA-ML-2311 and MUVA-CA-0904 were used. The results (Table 17) match well with Reference values of lactose monohydrates. The results for galactose and glucose (0.24 mg/g, respectively) from MUVA-ML-2311 could have been reported as well (although it’s not under the scope of the method).

Yes.

Not really.