肝素原料标准.pdfVIP

CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 201370Orig1s000 CROSS DISCIPLINE TEAM LEADER REVIEW This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. /s/ ALI H AL HAKIM 06/28/2011 Reference ID: 2967195 Cross Discipline Team Leader Review NDA 201370 potency assay. In addition, specific tests such as pH, loss on drying and bacterial endotoxin are provided as part of the specification. Heparin sodium injection potency is determined by Anti-Factor IIa assay. (b) (4) The NDA contains adequate and appropriate descriptions of the manufacture, characterization, controls and quality of the Heparin Sodium which meet the current USP heparin sodium. DMF 2712 was reviewed and found acceptable to support the NDA. The drug substance has (b) months retest period. (4) The manufacturing process for heparin sodium injection utilizes (b) (4) The proposed specification conforms to heparin sodium injection USP monograph. (b) (4) all test methods (Potency, Bacterial Endotoxin, Particulate Matter, pH, Sterility, Volume in Container, and Identification) used for testing heparin sodium injection are USP methods.