Bioanalytical Methods

Method validation is one of the most crucial components in any regulatory submission. We can conduct method validations for various analytical methods; from simple UV based assays to complex chromatographic methods for impurities and related substances. Our validation protocols and reports are based on globally acceptable guidelines like ICH/FDA/USP guidelines and cover various parameters like

a. Accuracy b. Precision c. Linearity d. Range e. Specificity f. Limit of detection g. Limit of quantification h. Robustness i. Stability in biological matrix

Auriga’s Bio-Analytical wing is our forte which is well equipped with state of the art equipments. Some of the main facilities of the bio-analytical laboratory include chromatography laboratory with HPLCs and GCs, LC-MS/ MS laboratory, ICP- MS laboratory, GC- MS laboratory, Cold room and deep freezer for sample storage.

A number of validated analytical methods available in the lab and are constantly work is going on more and more methods in the pipeline. Diverse array of analytical techniques available in our facility allow us to quickly develop and validate methods for even the most challenging molecules. This has never been a bottleneck in our services.

In house methods developed by our bioanalytical team is listed below