Testing Services

Method Development & Validation

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Quantum's chemists develop analytical methods that are robust, transferable, reproducible, and designed to generate quality results.

Quantum's method development services ensure that your team makes the best decisions and hits its development milestones. Our goal is to fully understand both the requirements of the method and the nature of the compound or material. Starting from this definition, we evaluate parameters and identify critical quality attributes. This results in methods that are fit for purpose, ranged properly, and that can be quickly validated.

Our scientific staff's depth of experience with analytical method development and method qualification makes Quantum uniquely suited to tough compounds, materials and projects. We’ve developed methods for synthetic and natural products, methods to quantify impurities and methods that are improvements to those found in pharmacopoeias, such USP, to name a few. If the compounds or materials in your development programs don’t fit the simple models, talk to us.

Method Development
Attributes Evaluated

System Suitability

Precision

Evaluation of Limit of Detection (LOD) & Limit of Quantitation (LOQ)

Sample Stability

Linearity

Standard Stability

Accuracy

Evaluation of Range

Methods Developed for

Purity

ICH Q11 support

Potency (assay)

Molecules /materials with unique complexity or properties

Impurities

Robust methods for fast method transfer

Stability indicating methods