A Complete Analytical project development
We undertake complete analytical project development activities for formulation as well as API products. This includes analytical method development for RMs, Intermediates, Inprocess and finished product in line with regulatory requirements.
Partial Development Projects
We undertake development of critical parameters or methods.
• Analytical method to determine impurities, which don't have chromophores and hence don't have detection.
• Analytical method to determine impurities, where recovery is a problem.
• Analytical method to determine impurities, where desired detection level is not achieved.
• Chiral method development.
• LC-MS suitable method development.
• Method development for particle size analysis.
• Polymorph quantification by XRD.
Analytical Method Validation
We undertake method validation studies as per ICH guidelines. This includes analytical method validation of compendial and non compendial chromatographic method. We also undertake project for analytical method development and validation for cleaning procedures. Method Validation projects for AMV of PSD and XRD methods are also accepted by us. We have facility to perform forced degradation and photo stability studies as per ICH guidelines.
DMF Related Activities
DMF related activities such as
A) Addressing and showing absence of impurities, residual solvents and metals by means of carry over studies which may be present in.
• Critical RMs.
• Used in the process.
B) Determination of physico chemical properties as follows:
• Solubility with respect to temperature and pH.
• Dissociation constant and partition coefficient
• Polymorphic evaluation.
Method Development Document
We prepare a complete report of method development along with supporting data. This report is then delivered to the client.
We do method transfer of the methods are developed by us at customer’s laboratory.