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Protein Kinase Inhibitors

Protein kinase inhibitors (PKIs) are NCEs developed to inhibit cellular pathways mediated by protein kinase.

With a full analytical package for NCEs, Quality Assistance provides scientific and technical support to pharmaceutical companies developing PKIs.
 
Throughout non-clinical and clinical development, our scientific team provides you with customised solutions in terms of analytical protocols and innovative technologies to help you move your product towards registration.
 
Thanks to a full range of equipment in Chromatography, Mass Spectrometry, Biochemistry, Pharmaceutical Technologies and Microbiology, Quality Assistance meets all the challenges of developing and validating methods which are further implemented in your batch release, stability studies or bioanalysis pharmacokinetic assessments.

Our capabilities in this area are summarized in the following table:

Identity
Identification TLC / (U)HPLC (UV, DAD, MS) / UV / IR
Composition (U)HPLC/MS
Quality & Product-related impurities
Chirality (U)HPLC (UV), Circular Dichroism, CE (UV, LIF)
Dissolution profile HPLC-UV dissolution tester
Assay

(U)HPLC (UV, DAD, RI, fluorescence, ELSD, CAD, conductimetry, PAD, MS)

GC (FID, ECD, MS, headspace)

CE (UV, LIF)

ICP (OES, MS)

Automated titration

Dosage uniformity
Product-related impurities
Genotoxic impurities
Process-related impurities
Microbiology Bioburden
Water content KF / Coulometer
Elemental impurities ICP (OES, MS)
Residual solvents HS-GC (FID, ECD, MS)
Pharmacokinetics & Toxicokinetics
APIs, metabolites UPLC (MS/MS) / ESI-QTOF
Biomarkers ELISA / ECL (MSD) / Luminex / UPLC (MS/MS)
Vehicles / Buffers (U)HPLC-UV / ICP-MS

 

 

protein-kinase-inhibitors-pkis-quality-assistance

You can download the full table of PKI analysis here!

 

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