Acceptance criteria bacterial endotoxins immunosera for human use

[Olgamargarita]

Good moorning, I would appreciate if someone help me with this request: Which will be the acceptance criteria of bacterial endotoxins test of Sodium chloride USP which is used in the manufacture of immunosera for human use? I search on brithish farmacopeia and only find pyrogens test. I do not know what is the endotoxins bacterial limit.

thanks a lot!!

 

[Statistical Steven]

I assume you are following USP <85> for Endotoxin. You will notice that the acceptance criteria for endotoxin is mongraph specific. The level of bacterial endotoxins is such that the requirement under the relevant dosage form monograph(s) in which Sodium Chloride is used can be met. Is this used for injection?

 

[Olgamargarita]

The product "monovalent anticrotálico serum" is an antidote administered via intravenous , intramuscular or subcutaneous, I could not find any USP monograph specific to dosage form serum in order to use the level of bacterial endotoxins in the raw material sodium chloride. the british monograph "immunosera for human use" only consider pyrogen test but not consider bacterial endotoxins test, so what reference I can consider to determine the limit level of bacterial endotoxins in intravenous form? I was searching on WHO but It was not successful. Please help me!! we we will have an audit coming.

 

[Statistical Steven]

The product "monovalent anticrotálico serum" is an antidote administered via intravenous , intramuscular or subcutaneous, I could not find any USP monograph specific to dosage form serum in order to use the level of bacterial endotoxins in the raw material sodium chloride. the british monograph "immunosera for human use" only consider pyrogen test but not consider bacterial endotoxins test, so what reference I can consider to determine the limit level of bacterial endotoxins in intravenous form? I was searching on WHO but It was not successful. Please help me!! we we will have an audit coming.

Since no specific monograph exists, I would assume you can use the sodium chloride injection monograph where the limits are as follows:

Bacterial Endotoxins Test 〈85〉: NMT 0.5 USP Endotoxin Unit/mL where the labeled amount of sodium chloride in the Injection is between 0.5% and 0.9%, and NMT 3.6 USP Endotoxin Units/mL where the labeled amount of sodium chloride in the Injection is between 3.0% and 24.3%

Please not this is not an official endorsement, but rather my interpretation of your question.