About This Service
Our Analytical Method Development and Validation (AMD & AMV) services provide scientifically sound, regulatory-compliant analytical methods for pharmaceutical and chemical applications. We develop stability-indicating HPLC methods, GC methods for residual solvents, dissolution methods, and cleaning validation methods, followed by full ICH Q2(R1) validation.
Key Information
Accredited by
What's Included
Instruments Used
HPLC (UV/PDA/FLD/RI)
Method development and validation for assay, RS
GC-FID with Headspace
Residual solvent method development
LCMS/MS
Trace-level impurity method development
Dissolution Apparatus USP I/II
Dissolution method development
Regulatory Standards
How We Work
Feasibility & Literature Review
Review of existing methods, regulatory guidance, and molecule characteristics.
Method Development
Systematic optimization of chromatographic conditions, mobile phase, and detection.
Validation Execution
All ICH Q2(R1) parameters tested with pre-approved validation protocol.
Validation Report
Comprehensive validation report with all data, acceptance criteria, and conclusions.
Ready to Start Your Analytical Method Development & Validation?
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