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Endotoxin limit & MVD

FREE

EL = K/M and the maximum valid dilution for BET.

5 EU/kg for most parenterals; 0.2 EU/kg intrathecal.

Within limits

EL = 0.5 EU per unit. MVD = (0.5 × 10) ÷ 0.125 = 40. Maximum valid dilution: 1 in 40.

Reference: USP <85>, Ph. Eur. 2.6.14. Always follow your approved SOP and current pharmacopoeia.