Development Services
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.
• Hygroscopicty.
Method
Development Document
We prepare a complete report of
method development along with supporting data. This report is
then delivered to the client.
Method Transfer
We do method transfer of
the methods are developed by us at customer’s laboratory.