A wide range of chromatographic separation techniques (HPLC, UPLC, GC, GFC and IC) and detection techniques (UV, ELSD, CAD, RI, FID etc...) are used to to meet different types of compounds.
Robust analytical method is one of the keys to quality product development and faster regulatory approval. At Monvi, we develop product specific analytical methods, which are best suitable for intended use of application by applying DOE to analytical methods.
The Analytical Services team has expertise in developing analytical methods for:
     Identification
     Assay
     Related impurities
     Chiral purity
     Residual solvents
     In-vitro dissolution
     Wet chemical methods
     Molecular weight determination for large biomolecules by SFC

Method validations are carried out as per latest regulatory guidelines for assay, related impurities, chiral purity, residual solvents, in-vitro dissolution, and wet chemistry methods.
At Monvi, Analytical method validations are executed in alignment with stringent SOP, which is based on ICH Q2 guidelines and in adherence to cGMP & GLP requirements.
Validation experimentation includes:
     Specificity
     Forced degradation studies
     Precision
     Accuracy
     Linearity
     Quantitation limit/Detection limit
     Stability of analyte in solution
     Robustness studies
     System suitability
Good documentation practices are followed throughout the process and an exhaustive and scientifically documented validation report is provided to the customers.