Analytical Method Development
Guided by quality and compliance, MOD3 Pharma provides access to a wide range of analytical services to support the development of OINDP drug products.
Our end-to-end analytical support covers all stages of development, from early characterization of drug substance and solubility screening to multifactorial stability studies and process validation. We have a passion for HPLC analysis and pride ourselves in developing methods for low-dose products.
Our analytical team has extensive knowledge of current and evolving FDA and ICH guidelines, and we apply a risk-based, phase-appropriate approach to cGMP analytical activities along with industry-leading analytical method development and analytical validation.
OINDP Testing Equipment
- Malvern Mastersizer 3000 with Aero S Dry-Dispersion Unit
- Malvern Spraytec 2000 with Nasal Spray Support Unit
- Proveris SprayVIEW Measurement System
- Proveris Vereo Automated Actuator
- Copley Critical Flow Controller TKP 100i with Vacuum Pump
- Copley Model 200 Breathing Simulator
- MSP Next Generation Pharmaceutical Impactors (NGI)
- General Purpose Thermal Mass Flowmeter (TSI)
Chromatographic Systems
- Waters Empower 3 Chromatographic Data System
- Waters Arc Premier High Pressure Liquid Chromatograph with a Photodiode Array Detector and a Single Quadrupole Detector Mass Spectrometer
- Waters Arc Premier High Performance Liquid Chromatograph (2)
- Shimadzu High Performance Liquid Chromatographs (7)
- Corona Veo RS Charged Aerosol Detector (CAD)
- Waters Photodiode Array Detector (PDA)
- Waters and Shimadzu UV-Vis detectors
- Perkin Elmer Clarus 690 Gas Chromatograph with flame ionization detector (FID)
Analytical methods
- Pharmacopeial and internal HPLC methods for assay and related substances
- Headspace GC methods for residual solvents
- Residual water by Karl Fischer titration, USP <921>, method 1c
- Particle size distribution by laser diffraction, USP<429>
- Delivered Dose Uniformity, USP<601>
- Microbial enumeration tests, USP<61> and <62>
- Other testing as described in USP<5>, <601>, <905>, <1111>, <1601> and <1664.1>
- Other testing as described In FDA guidance documents
