Low Lactose ERP - Review Book

3. Is there information demonstrating that the

Yes. However, the method does not clearly indicate how to deal with residual ß galactosidase that may be present. In the systems they tested they found no significant amounts that would affect their study. Most likely any small of the residual enzyme are negligible when the enzyme is added for the analytical step, but it would be good to have protocol for non-negligible amounts

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

The methods should include a statement about adjusting the solution concentration if the spectrophotometer absorbance is above 1.5 or so ( for high levels of lactose). Absorbance measurements above 1.5 can start to go non- linear since the levels of light transmittance start to drop significantly (the exact threshold is instrument dependent).

Yes.

Yes, except for sodium caseinate, MUVA CA 0904, see my comments above.

Yes. There are a few parts that need to be checked over for typos and other small editing issues.