Endotoxin limit of sodium chloride injection = 0.5 EU/ML
And metronidazole injection = 0.35 EU/MG
Formula is calculation the Endotoxin limit= K/M
How to calculate Endotoxin limit sodium chloride injection and metronidazole injection as per given formula.
Endotoxin limit =K/M
Where K =5 EU/kg of body weight for any parenteral route of administration
other than intrathecal.
M=The maximum recommended bolus dose of drug per kg of body weight
Note: when the product is to be injected at frequent intervals or infused
continuously,
M becomes the maximum total dose administered in a single
hour period.
In above case , M= 10 ml/kg for sodium chloride injection and M= 15 mg/ kg for metronidazole injection. and K value will be 5 for both injection. now u can calculate by using formula-
endotoxin limit for sodium chloride injection = 5/10 =0.5 EU/ML
Endotoxin limit for metronidazole injection = 5/15 =0.33 EU/MG.
Ok but how to determine M= 10 ml/kg for NS and 15 mg/kg for metro…
2nd question is levofloxacin infusion BET limit not given in IP. How to find endotoxin limit as per K/M. please reply me
Maximum dose of drug is decided by clinical trails.