ILT-U-760
Drugs determinations. 1A
DETERMINATION | STANDARD |
| Sterility | membrane filtration method |
| Sterility | by direct inoculation method |
| Antimicrobial Effectiveness Testing | United States Pharmacopeia 36 <51> – NF 31 de 2013 |
| Toxicity 48 hours | United States Pharmacopeia 36 <88> – NF 31 de 2013; European Pharmacopoeia 7.0 <2.6.9>; 2012 |
| Bacterial endotoxins | – determination using gel clot “in vitro pyrogen” United States Pharmacopeia 36 <85> – NF 31 de 2013; |
| Pyrogen in vivo | United States Pharmacopeia 36 <151> – NF 31 de 2013 |
| Biological Reactivity Systemic | United States Pharmacopeia 36 <88> – NF 31 de 2013; |
| Biological Reactivity intracutaneous | United States Pharmacopeia 36 <88> – NF 31 de 2013; |
