Method Development & Validation

 

Our style of project management and approach to analytical methods development and validation is in compliance with up-to-date industry standards.  Our development principles are based on:


 

 

 

Method Development & Validation

a. Potency
b. Dissolution
c. Impurities
d. Moisture
e. Metals
f. Residual solvents
g. Physical-chemical tests
h. Methods for the detection of actives and cleaning agents
i. Review and update Drug Master Files (DMF), to ensure compliance with industry standards Validation Services
j. Stability-indicating

a. Method precision (intermediate and reproducibility)
b. Limit of detection
c. Limit of quantitation
d. Robustness
e. Filter studies
f. Flush volume studies
g. Accuracy and recovery studies
h. Linearity and range
i. Specificity including forced degradation analysis

We work closely with our clients from the design of the method development protocol to the final validation report and transfer.

a. Evaluation of Drug Master Files (DMF) packages to determine compliance with FDA regulations
b. Methods remediation, in order to bring old methods up to today's industry standards
c. Non-routine methods development, including dissolution by:

Stason utilizes such instrumentation as GPC, ICP, LC/MS, IT/MS, FTIR, LC, GC and GC/MS.

Download Instrument List