Our laboratory validates analytical procedures according to the requirements of ICH, Pharmacopoeia of Ukraine, USP. Validation may include next parameters:
- Accuracy
- Linearity and range
- Specificity – components of the matrix
- Specificity – Product degradation
- Robustness
- Limit of detection limit (LOD), Limit of quantification (LOQ)
- Stability of standard and test solutions
- Precision
Central Laboratory offers development and optimization of analytical procedures in the following areas:
- Quantitative tests, impurity tests, stability testing methods
- Techniques for dissolution test, dissolution profile comparison techniques
- Residual solvents
- Methods for validation of the cleaning processes for equipment or glassware
Our principles on development of analytical procedures:
- Minimal time for analysis
- Minimal use of organic components and ecological safety of developed procedures
- Chromatographic conditions should be “friendly” to your hplc-column
- Minimal costs for analysis by means of developed procedure
- Procedure should be reliable and robust