Method Validation Parameters

• Explain the purpose of analytical method validation
• Explain the difference between Category 1 and Category 2 analyses
• Define ‘Specificity’ as it relates to HPLC analysis
• Explain the difference between the terms ‘Accuracy’ and ‘Precision’
• Describe how stress testing is done as part of method validation
• Define the term ‘Limit of Detection’
• Define the term ‘Limit of Quantification’

Learner Benefits:

• Clear Understanding of Validation Purpose: Develop a foundational understanding of why method validation is essential in ensuring laboratory test accuracy and regulatory compliance.

• Insight into Specific Analytical Techniques: Gain knowledge on Category 1 and Category 2 analyses, with detailed insights into standards used for measuring active ingredients and impurities.

• Enhanced Knowledge of Key Analytical Parameters: Learn critical definitions and applications of specificity, accuracy, and precision, and understand their roles in method validation.

• Awareness of Stability Testing Requirements: Understand the importance of sample stability during testing, ensuring accurate and reliable results under standard laboratory conditions.

• Mastery of Detection Limits in HPLC: Grasp the significance of the Limit of Detection and Limit of Quantitation, key indicators of an analytical method’s sensitivity and reliability in detecting and measuring impurities.

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