• ACCURACY
• Precision

1. Reproducibility
2. Repeatability
3. Intermediate Precision (Ruggedness)
4. Instrument Precision

• Specificity
• SELECTIVITY
• Limit of Detection
• Limit of Quantization
• Linearity
• Range
• Robustness
• Ruggedness

Other VALIDATION Considerations:

System Suitability - Used to verify that the resolution and reproducibility of the chromatographic system are adequate for the analyses performed.

Solution Stability - Determines the stability of the solution after preparation in accordance with the test method.

• Consideration must also be given to reagents, chemicals, mobile phase, ETC.

Stress Testing - Demonstrates the specificity of the assay and analytical procedures for impurities. We need to ensure that "no interference with quantization is evident from impurities and degradants from the active ingredient and excipients."

Stability indicating nature of analytical method can be proved using specificity and stress testing by SHOWING the peak purity.

Other Validation Considerations:

System Suitability - Used to verify that the resolution and reproducibility of the chromatographic system are adequate for the analyses performed.

Solution Stability - Determines the stability of the solution after preparation in accordance with the test method.

Stress Testing - Demonstrates the specificity of the assay and analytical procedures for impurities. We need to ensure that "no interference with quantization is evident from impurities and degradants from the active ingredient and excipients."

Stability indicating nature of analytical method can be proved using specificity and stress testing by showing the peak purity.