Method Development and Validation

We develop and validate a wide variety of analytical methods using all types of instrumentation and techniques. The methods can also be transferred back to the client or a third-party. All work is performed under GLP/GMP regulations. The latest FDA and ICH guidance are followed where applicable.

Below is a brief listing of our capabilities:

	Stability-Indicating methods for assay, related substances and degradation products using HPLC, HPLC/MS, GC, GC/MS, Ion Chromatography
	Residual Solvents by GC-FID, GC-MS and Headspace GC-FID or GC-MS
	Stability, uniformity and concentration verification of test article in preclinical formulations for GLP studies
	Dissolution Testing
	Chiral Impurity by Chiral HPLC or GC
	Free/Bound drug concentrations in lipid formulations
	Polymorphic Determination
	Particle Size Analysis
	Identification tests using various techniques

The above list in not all-inclusive and your special request is welcome!