Unless otherwise requested in accordance with any other guideline, residue solvent determination analysis, separation of volatile compounds, and purity determination are performed by gas chromatography (GC) in our laboratory in accordance with ICH Q3C and USP <467> guidelines.
Endotoxins are toxic substances that can be produced by the destruction of the cell walls of gram-negative bacteria. Endotoxins appear in the sample with the deterioration of the cell wall structures of gram-negative bacteria (death of bacteria).
Bacterial endotoxin performed to prove that injectable products do not have a pyrogenic effect. Bacterial endotoxin test is performed for the following products:
- Injectable products for human and veterinary use
- Medical devices
- Raw materials and excipients used in the production of injectable products
- Water samples used in the production of injectable products
- Bacterial endotoxin testing is performed in accordance with USP43-NF38 <85> and EP 9.8 <2.6.14> standards, unless otherwise specified. According to these standards, endotoxin testing is performed in our laboratory using the Kinetic-Turbimetric method.
Kinetic Turbidimetric Method: based on measuring the increase in turbidity caused by the destruction of the endogenous substrate over time.
In the analysis performed in our laboratory using the Kinetic-Turbidimetric Method, the sensitivity of endotoxin detection is 0.001 EU/ml.
Bacterial Endotoxin and Method Validation
Bacterial Endotoxin Method Validation Study is carried out in our laboratory as stated below.
Validation Preparation Tests:
It is performed to prove the validity or accuracy of the endotoxin test.
The purpose of the preparation tests is to demonstrate the suitability of the standard curve and to demonstrate that the test solutions do not interfere with the test. Furthermore, appropriate concentrations for the validation study are determined through preparatory tests.
Interfering Factors Test:
It is done to prove that the product does not interfere with the test by increasing or decreasing endotoxin during the test.