Analytical Development
We provide full range of analytical services, including method development and validation, analytical testing and release, stability study, large scale separation and regulatory CMC documentation services. State-of-the-art instruments, cutting-edge technologies, and experienced scientific staff ensure efficient, high-quality and cost-effective services.
- End-to-end services with high quality and fast turnaround time providing cost effective solutions
- One stop shop for all needs in analytical & stability and quality control
Method Development and Validation
- A wide range of chromatography techniques (HPLC, UPLC, GC,) and detection technologies (UV, RI, FID, ECD, ICP, Florescence, etc) to meet the requirements of different types of compounds
- Stability-indicating assay and/or related substances methods for drug substance and drug products (tablets, capsules/liquid filled capsules, solution/suspension, powder, beads/coated beads, injectables, topicals, solid dispersion, etc)
- Other specific methods, like dissolution (IR, ER, MR), residual solvents and cleaning validation
- Provide method development experimental design, progress report, method validation protocol and report, method monograph
Analytical Testing and Release
- Full or customized release for API and drug product (GMP or GLP)
- Analytical support for formulation development and cleaning validation
- Reference standard characterization with CoA or full characterization report
- Full excipient release as per USP, EP, ChP or JP
- Confirmation of structure or absolute configuration determination
- Degradation pathway ascertainment with report for regulatory submission
- Microbiological testing: microbial limit, endotoxin, bioburden, water, sterility testing, environmental monitoring, etc