Preparative purification
Synthetic Compounds
The development of small molecule pharmaceuticals is broadly divided into two parts: 1) investigative research to discover new drug candidates from a number of compounds, and 2) developmental research to evaluate the effectiveness and safety of new drug candidates in preclinical and clinical trials utilizing humans and animals, and to verify their usefulness as pharmaceuticals. In both cases, it is necessary to ensure reliability and analytical accuracy, respond to regulatory conditions, and address a variety of other needs. The quality of analytical techniques at pharmaceutical manufacturing companies is the key to new drug development. Shimadzu offers effective solutions for all of the processes related to small molecule pharmaceuticals, from drug discovery and development to quality control and manufacturing.
Preparative purification
Synthetic Compounds
Formulation
Cleaning Validation
Method development
QA/QC
PIC/S and FDA Compliance
Impurities, Genotoxic Impurities and Elemental Impurities
Residual Solvents in Pharmaceuticals
Physical Properties and Observations
Toxicity Evaluation
Pharmacokinetics
Drug development and quality control
Regulatory Compliance
Data Integrity