Low Lactose ERP - Review Book

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. 5. Based on the supporting information, what are the pros/strengths of the method?

yes

yes

Method may require changes in formatting inline to SMPR w.r.t to specification. As per SMPR the range is mg /100 g 5-100,10-100 and 100-2000 where as in the method 0-200 mg/ml, 0-2 g/ml and 0-6 gm/ml.

Method covers more validation parameters than specified in SMPR i.e stability, reproducibility and material lot to lot consistency.

Cover entire range of concentrations unto 6000ppm .

used the harmonized material specified in SMPR and also participated in proficiency testing with acceptable Z- Score.,

Evaluated equipment performance with third party lab.

6. Based on the supporting information, what are the cons/weaknesses of the method?

During validation not used NIST CRM.

calculation of Recovery from the linearity may not be required.

preparation of working standard and working standards need to be elaborated.

As per SMPR , Interferences study not conducted for Amine contacting compounds ( glucosamine Hcl, amino acids, peptides and glycoproteins etc.

7. Any general comments about the method?

Based on presented data method meet the requirements of SMPR however require improvements in formatting/ presentation.

V. Final Recommendation Do you recommend this method be adopted as a First Action and published in the Official Methods of Analysis of AOAC INTERNATIONAL? Please specify rationale.

Yes, the method is recommended for First action if the above mentioned points addressed appropriately.