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The maximum valid dilution is the maximum allowable dilution of a specimen at which the endotoxin limit can be determined. Determine the MVD from the following equation:
MVD = (Endotoxin Limit × Concentration of Sample Solution)/()
Endotoxin Limit— The endotoxin limit for parenteral drugs, defined on the basis of dose, equals K/M2, where K is a threshold pyrogenic dose of endotoxin per kg of body weight, and M is equal to the maximum recommended bolus dose of product per kg of body weight. When the product is to be injected at frequent intervals or infused continuously, M is the maximum total dose administered in a single hour period. The endotoxin limit for parenteral drugs is specified in the individual monograph in units such as EU/mL, EU/mg, EU/Unit of biological activity, etc.
Concentration of Sample Solution—
mg/mL: in the case of endotoxin limit specified by weight (EU/mg);
Units/mL: in the case of endotoxin limit specified by unit of biological activity (EU/Unit);
mL/mL: when the endotoxin limit is specified by volume (EU/mL).
: the labeled sensitivity in the Gel-Clot Technique (EU/mL) or the lowest concentration used in the standard regression curve for the Turbidimetric Technique or Chromogenic Technique.