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Appendix E
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The Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices, Food and Drug Administration, Rockville, MD, December, 1987 with Maximum Dose and Endotoxin Limit Table, Appendix E, 1993.
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