English to Russian Medical Medical: Pharmaceuticals

Validation of SOP OR-13-00043 Quantitative Determination of Endotoxins (LAL) / Kinetic Method - Protein C Final Container 100 IU/ml
[OR1300043-CVRC2.03]
Classification of Analytical Procedure
According to ICH Q2 (R1) this compendial analytical procedure is classified as impurity test.
The data in this report are taken from a product specific validation of a Pharmacopoeia method in accordance with Ph.Eur.
2.6.14 (current edition) and USP (current edition).
Bacterial Endotoxin Test (BET) was classified according ICH Q2 (R1) parameters, but as this is a compendial method BET does not require a full validation project according to ICH Q2 (R1).