Bioanalysis for Small-Molecule Drugs Using LC–MS/MS

With over 30 years of extensive analytical experience, Sumika Chemical Analysis Service, Ltd. (SCAS) offers highly sensitive quantification services for small-molecule drugs (small molecules), their metabolites and related endogenous biomarkers in biological matrices, including plasma, serum, urine, cerebrospinal fluid, tissues and organs derived from human and various animal sources, as well as cells and cell culture media, using the latest LC-MS/MS.

We provide comprehensive support services across all stages of drug development, as follows:

• Exploratory pharmacokinetic (PK) studies
• Exposure assessment in pharmacology studies
• PK analysis in pharmaceutical formulation research
• Quantitative analysis of drug concentrations in nonclinical safety (toxicokinetic, TK) studies and clinical trials

Our bioanalytical methods are validated, and sample analyses are conducted in accordance with ICH M10 (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Guideline M10).

We develop highly sensitive and specific analytical methods, optimizing all conditions and parameters from sample pretreatment methods to LC-MS/MS (e.g., Triple Quad™ 7500) conditions to ensure robust analytical performance. Our capabilities include trace-level quantification, multicomponent analysis, and selective determination of small-molecule payloads, which are released from antibody-drug conjugates (ADCs).
We also offer metal element analysis with ICP-MS and volatile compound analysis with GC-MS.

Our method validation studies are evaluated based on the following parameters:

• Selectivity
• Lower limit of quantitation (LLOQ)
• Calibration curve linearity
• Accuracy and precision
• Matrix effects
• Carryover
• Dilution integrity
• Stability

We perform quantitative analysis of drug concentrations in biological samples obtained from PK and TK studies in both nonclinical and clinical stages of drug research and development. Pharmacokinetic parameter calculations are also available.

• Pharmaceuticals and Medical Devices Agency: "ICH M10 Bioanalytical Method Validation and Sample Analysis", <000272440.pdf>, (accessed 2025.11.28).