Analytical Method Development & Validation

Leading Analytical Excellence with Modern Technology and Innovation

Our integration of advanced in-silico modeling tools with sophisticated instrumentation, along with our years of experience and success, allows us to optimize and streamline the separation of key components. Our streamlined workflow allows us to achieve faster method development with increased knowledge of the design space, leading to robust analytical methods ready for commercial transfer. Our close collaboration with our clients allows us to develop methods that meet or exceed their requirements, faster.

Analytical Development Support

• Walk-up LC-MS, GC-MS, SFC-MS, NMR for fast sample analysis
• Method screening and rapid enabling method development
• Structural identification and characterization of process related impurities and degradants
• Support DOE, fate & purge experiments
• Technology transfer to clinical and commercial facilities
• Stability risk assessment and testing

Analytical Method Development

• Establishing key predictive sample set of process related impurities and degradants
• In-silico and multi-variant method development
• PAT assessments and implementation
• Genotoxic impurities and nitrosamine method development

Method Development Workflow

Our analytical team can support the transfers of analytical methods, leveraging their many years of experience in performing method transfers to third parties and commercial sites. We will work closely with our client to understand their requirements and can offer a variety of services to suit their needs including planning, execution and conclusion of method transfers.

Method Validation

Asymchem provides comprehensive support for the validation of analytical test methods, providing expert guidance determining stage-appropriate validation and strategies. Our validation processes can be customized to suit the specific requirements of clients at any stage of development.

Method Validation and Verification

• Validation strategy and criteria selection
• Protocol authoring and reviewing
• Execution of validation experiments
• Validation report summary writing
• Verification of compendial methods

Analytical Techniques and Capabilities

At Asymchem, we have state-of-the-art laboratories equipped with a variety of sophisticated analytical equipment, to meet client’s needs and requirements. Our scientists are highly experienced and offer services in the development of a wide range of analytical methods including genotoxic impurities, elemental analysis, nitrosamines and identification of unknown compounds.

Analytical Techniques and Capabilities

Chromatographic: LC, GC, IC, SFC, CE

Spectroscopic: NMR (1H-NMR, 13C-NMR, 19F-NMR, 31P-NMR, Homo/Hetero-Nuclear 2D-NMR, qNMR) FTIR, Raman

Detection: UV, DAD, cCAD, FID, CD, PAD, FLD, TCD

Mass Spectrometry: LC-MS, LC-MS/MS, GC-MS, SFC-MS

Elemental Analysis: ICP-MS, ICP-OES, XRF

PAT: Mid-IR, Blaze microscopy, FBRM

Physical Properties: PSD (Wet and Dry), PXRD, DVS, DSC, TGA

General: KF (Coulometric, Volumetric & Oven), ROI, LOD