Analytical Method Development
Diverse Analytical Services to Assess Compound Quality
To help you achieve the desired quality and performance of your compound, Recro’s veteran scientists customize solutions for your complex products.
Our team adheres to global ICH guidelines to ensure the development of safe, effective, high-quality pharmaceutical products.
Recro’s best-in-class, 120,000-square-foot manufacturing space houses a full range of analytical testing services and analytical equipment for multiple dosage forms.
- Raw material, in-process and finished product release testing
- ICH stability testing, including photo stability
- Physiochemical characterization
- Method development and validation (assay, impurities, dissolution and cleaning)
- Residual solvents by GC
- Chromatography, including high-pressure liquid chromatography (HPLC), ultra performance liquid chromatography (UPLC) and gas chromatography (GC)
- UPLC with PDA (photodiode array) and QDa (single-quad Mass spectrometry) detectors for forced degradation studies and impurity identification
- Particle size analysis
- Moisture analysis
- Air sampling
- Total organic carbon (TOC)
- Polarimetry, melting point, densitometer, refractive index
- Stability Chambers