Analytical chemistry
Olon USA provides you with a comprehensive range of on-site analytical chemistry services to fully support the drug development process, from preclinical to post-marketing phases. We have decades of experience conducting studies in compliance with the US FDA– GLP/cGMP regulatory requirements and the International Conference on Harmonisation (ICH).
Analytical-Chemistry-Quality-Control
Comprehensive research, development and manufacturing support of drug substance, drug product and specialty materials
Primary Service Offerings
Method Development & Validation
- Assay / Potency/ Content
- Impurities / Related Substances
- Stability Indicating / Forced Degradation Studies
- Chiral & Polarimetry Methods
- Residual Solvents
- Counterion Methods
- Elemental Impurities
- Spectroscopy for ID and Quantitation
- Genotoxic and Trace Impurities
- Dose Formulation Analysis
- Pharmacopeial Methods (USP/EP)
Preformulation
- Salt Screening
- Polymorph Screening
- Co-crystal Screening
- Vehicle Screening
- Solubility, log P, pKa
Characterization & Reference Standard Programs
- Impurity Isolation and Identification
- Structural Elucidation & Purity Assignments
- Reference Standards Qualification & Inventory Program
- GMP and GLP CoAs with Chain of Custody
- Periodic Recertification & Managed Distribution
- Purification and Synthesis of Standards
Quality Control - Release Testing
- Raw Materials / Intermediates
- API / Drug Product
- Preclinical to Commercial
- Method Transfers
ICH Compliant Storage Stability
- Accelerated and Long-Term Storage Programs
- Freeze-Thaw, Temperature Cycling, Hold-Time
- Photostability ICH Q1B
- -80°C, 5°C, -20°C, 25°C/60%RH, 30°C/65%RH, 30°C/75%RH, 40°C/75%RH
- Customized Interim and Final Reports
Primary Instrumentation/Equipment
- HPLC, UHPLC and prep-HPLC
- Ion Chromatography
- GC-MS & Headspace and Direct Inject GC
- LC-MS/MS (Q trap) and UPLC-QTOF (exact mass)
- FT-NMR (including 2D and qNMR)
- FTIR and Raman Spectroscopy
- UV-VIS & Fluorescence Spectroscopy
- Light Scattering for Particle Size
- Polarized Light and Hot Stage Microscopy
- ICP-OES & ICP-MS
- KF- Volumetric, Coulometric, Oven, Titrators
- TGA, DSC, and dynamic vapor sorption
- XRPD with Variable Temperature
- Storage Stability Facility / ICH Storage Chambers
Download Area
Case studies
Sell sheets
Any questions?
Our competent, kind and friendly customer service team will be happy to help. Write us or call us to talk to a real human being.