Molecule Laboratory has the full facilities for the Analytical Method Validation on HPLC, GC, Dissolution Apparatus, UV Spectrophotometer, and for Titration Method.
Analytical Methods for Validation:
1. Assay
2. Related Substance
3. Dissolution
Method Validation Parameters:
1. Specificity
2. Linearity & Range
3. Accuracy or Recovery
4. Precision
a. Method Precision
b. Intermediate Precision (Ruggedness)
5. Robustness
6. LOD & LOQ
We perform method validation as per ICH guidelines.