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(Gold & Silver)

Contract Laboratory Services (CLS) > Pharmaceuticals Analysis >> Method Development, Validation & Transfer >>> Method Selection & Development

Our Method Selection & Development protocol is as follows:

• Understanding the molecule chemistry and Method application area (routine quality control, stability indicating, screening methodology, confirmatory technique etc.)
• Method Evolution
• Identification / Detection Techniques - options and trade-offs; typical applications and sensitivities.
• Accuracy
• Precision
• Linearity
• Specificity & Resolution (Separations)
• Sample Preparation & Clean-up (if any) – options and trade-offs; typical recoveries and matrix-effects
• Optimizing systems
• Optimizing test procedures
• Determining LOD, LOQ, MDL
• Statistical validation
• Method Stability
• Robustness (system suitability, system component contributions)
• Measurement Uncertainty
• Method Validation
• Method Transfer

 For more information on validations, email at validations@choksilab.com .