Residual Solvents Analysis & AMV
Accurate identification, quantification, and validation of residual solvents in pharmaceutical products to ensure safety, quality, and regulatory compliance as per global standards.
Our Services
- Residual solvent profiling (Class 1, 2, 3 solvents)
- Headspace GC method development
- Stability-indicating method validation
- Routine QC and batch release testing
Validation Parameters
- Accuracy & Precision
- Specificity & Selectivity
- Linearity & Range
- LOD & LOQ
- Robustness & Ruggedness
Analytical Techniques
Headspace GC-FID / GC-MS methods for precise detection and quantification of volatile organic solvents in pharmaceutical matrices.
Regulatory Compliance
Studies aligned with ICH Q3C guidelines for residual solvents and ICH Q2 (R1/R2) for method validation ensuring global compliance.
Key Benefits
Ensures patient safety, regulatory approval, and consistent product quality by controlling solvent residues within permissible limits.