Method Development & Validation
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Method Development & Validation
Method Development and Validation are critical components in pharmaceutical quality control and regulatory compliance. They ensure that analytical methods are suitable for their intended purpose, whether for testing raw materials, intermediates, or finished products.
Method Development
This involves designing and optimizing an analytical procedure to reliably detect, quantify, or characterize a substance.
Why choose?
Latest equipment
Testing equipment have significantly enhanced efficiency.
Safe diagnoses
Both accurate results and lab personnel/environmental safety.
Key Objectives
- Select appropriate techniques (e.g., HPLC, GC, UV, FTIR, etc.)
- Achieve specificity, sensitivity, and robustness
- Optimize parameters (e.g., pH, solvent, flow rate, detection wavelength)
Common Techniques
- High-Performance Liquid Chromatography (HPLC)
- Gas Chromatography (GC)
- UV-Vis Spectrophotometry
- Titration
- Mass Spectrometry (MS)
- FTIR/NIR Spectroscopy
Applications
- Quantification of active pharmaceutical ingredients (APIs)
- Detection of impurities or degradation products
- Identification of compounds in complex matrices
Method Validation
Once a method is developed, it must be validated to confirm its reliability and compliance with regulatory standards (e.g., ICH Q2(R1)).
Validation Parameters
- Accuracy – Closeness of results to true value
- Precision – Repeatability and reproducibility
- Specificity – Ability to measure the analyte in presence of impurities
- Linearity – Method’s ability to produce results proportional to concentration
- Range – Span over which the method is accurate, precise, and linear
- Limit of Detection (LOD) – Lowest amount of analyte detectable
- Limit of Quantitation (LOQ) – Lowest amount that can be quantitatively determined
- Robustness – Resistance to small deliberate variations in method parameters
- System Suitability – Ensures instrument and method performance are acceptable
Documentation
- Method validation protocol
- Raw data and statistical evaluation
- Validation report
Regulatory Guidelines Followed
- ICH Q2(R1) – Validation of Analytical Procedures
- USP <1225> – Validation of Compendial Procedures
- FDA and EMA guidelines
