Method Validation Services

QCL highly experienced scientists are equipped with an array of latest instrumentation and techniques including: HPLC, GC, Dissolution, FT-IR, and UV to develop and optimize methods. We work closely with our clients to develop and validate specific, sensitive and accurate methods.

Typical validation characteristics include:

o Filter Evaluation / Method Precision

o Limit of Detection (LOD)

o Limit of Quantitation (LOQ)

o Accuracy / Precision

o Recovery Studies

o Linearity

o Specificity

o Forced Degradation

o Range / Robustness

o Solution Stability

We also have an analytical development group with extensive experience in Cleaning Method Development/Transfer/Validation and Analysis of large numbers of cleaning verification residual samples using validated HPLC methods.