Development Analytical Support Services
We offer analytical support services for oral solids, liquids, creams, ointments and sterile injectable from our facilities in the US, UK, and India. As a leader in integrated solutions, we seamlessly engage our global sites to conduct drug development work in parallel,accelerating time to market and reduce costs for our customers.
API Properties
- Chemical: Solubility (equilibrium/kinetic), hygroscopicity, thermal behaviour, log P, and stability.
- Physical: Microscopy, particle size
Pre-formulation
- Solubility
- Forced degradation
- Particle size
- Excipient Compatibility
- Fast content uniformity
Formulation
- Analytical methods development/validation/transfer
- Clinical supply release
- ICH stability studies
- Identification of unknown impurities
- Cleaning validations
ORAL SOLIDS STERILE INJECTABLES Comparator testing: Fixed dose combination, modified release formulations Extractable and leachable studies Blend uniformity Forced degradation studies Hardness / Friability / Bulk density Moisture content Disintegration Residual solvent determination Moisture (KF and LOD) Cleaning validation Particle size distribution (granules) Raw material, in-process, and finished product testing Sieve fraction analysis Dissolution testing (immediate and extended release) - Stability Studies
- We currently offer stability programs with chambers covering -20°C, 2 ̶ 8°C, 25°C/60%RH, and 40°C/75%RH, as well as an R&D photostability chamber. Our wide variety of testing services, according to the International Conference on Harmonization (ICH) guidelines, will equip you with the data needed for your filing.
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Analysis of Support Formulation Development
- Excipient Compatibility
- Fast content uniformity
- Bio-relevant Dissolution for formulation selection
- Discriminatory dissolution method development based on solubility, pKa, ionization state, and excipients
Analytical (Microbiology)
- Environment Monitoring of classified areas
- Microbiological analysis of Water
- Microbial enumeration test
- Stability Studies along with preservative efficacy testing
- All testing as GLP requirements.
Analytical Testing Services
- Liquid chromatography (HPLC)
- Diode array detectors (DAD)
- Refractive index detector (RID)
- Gas chromatography (GC)
- Protein concentration (TOC)
- UV/Vis
- Infrared spectroscopy
- Karl Fisher (KF) moisture analysis
- pH determination
- Total organic carbon (TOC)
- Viscosity
- USP particulate testing: HIAC 9705
- Specific gravity
- Dissolution testing
- Particle size testing
- Zeta potential