Drug product development
Chemical analysis and development of methods to identify, characterise and test materials is an essential part of product development and on-going quality control.
Drug substance and drug products
At LGC, we provide a comprehensive analytical service to support your drug substance and drug products testing requirements from discovery to clinical development and full release testing.
Our extensive analytical capability includes the following:
- HPLC and UPLC with PDA, MS, UV, RI, ELSD
- GC and Headspace GC with FID, ECD, TCD, MS
- LC/MS/MS and MALDI QTOF
- Super critical fluid chromatography with PDA, MS
- ICP-OES, ICP-MS
- Atomic Absorption
- Optical Rotation
- Karl Fisher
- LOD and ROI
- Melting Point
- ID, potency and purity of drug substance and drug products testing
- Materials testing to USP, EP, BP and JP compenidal monographs
- Full release and in-process testing
- Phase appropriate method development, optimisation, qualification, validation and transfer
- Impurity profiles and specification limit development
- Genotoxin method development and testing
- Solubility and dissolution studies
- Excipient compatibility tests
- Content and blend uniformity
- Residual solvents and water content analysis
- Forced degradation studies (solution and solid phases as function of temp, humidity, light etc)
- Stability testing of drug substances and drug products to ICH guidelines
- Stability data trending and statistical analysis
- Stability protocol development and programme management
- Lipids and fatty acid analysis
Not only do we have access to the latest state-of-the art analytical equipment, we are constantly working with instrument manufacturers to push the boundaries of separation sciences. Our scientists combine a wealth of technical expertise with extensive knowledge and experience of industrial and regulatory requirements to support both routine and tailored analytical testing of a broad spectrum of compounds and dosage forms to your specific needs.
Our fully integrated facilities with physical and biological testing services also allow seamless advancement of your projects, making LGC your ideal partner for analytical testing.