Summary of the stability results observed for the above accelerated and long-term studies: Test Results Description Moisture Impurities Assay etc. Proposed storage statement and shelf-life (and in-use storage conditions and in-use period, if applicable): Container closure system Storage statement Shelf-life 2.3.P.8.2 Post-approval Stability Protocol and Stability Commitment (a) Stability protocol for Primary stability batches (e.g. storage conditions (including tolerances), batch numbers and batch sizes, tests and acceptance criteria, testing frequency, container closure system(s)): Parameter Details Storage condition(s) (◦C, % RH) Batch number(s) / batch size(s) <primary batches> Tests and acceptance criteria Description Moisture Impurities Assay etc. Testing frequency Container closure system(s) (b) Stability protocol for Commitment batches (e.g. storage conditions (including tolerances), batch numbers (if known) and batch sizes, tests and acceptance criteria, testing frequency, container closure system(s) : Parameter Details
Summary of the stability results observed for the above accelerated and long-term studies: Test Results Description Moisture Impurities Assay etc. Proposed storage statement and shelf-life (and in-use storage conditions and in-use period, if applicable): Container closure system Storage statement Shelf-life 2.3.P.8.2 Post-approval Stability Protocol and Stability Commitment (a) Stability protocol for Primary stability batches (e.g. storage conditions (including tolerances), batch numbers and batch sizes, tests and acceptance criteria, testing frequency, container closure system(s)): Parameter Details Storage condition(s) (◦C, % RH) Batch number(s) / batch size(s) <primary batches> Tests and acceptance criteria Description Moisture Impurities Assay etc. Testing frequency Container closure system(s) (b) Stability protocol for Commitment batches (e.g. storage conditions (including tolerances), batch numbers (if known) and batch sizes, tests and acceptance criteria, testing frequency, container closure system(s) : Parameter Details
NAFDAC-QOS-PD26379.docx