Pharmaceutical product/batch release testing is required before any drug is made available for clinical trials or market consumption. The product’s purity, concentration, consistency, safety, and integrity are just some of the factors evaluated during drug product release testing.
Avoid production delays by choosing an analytical partner with extensive experience and the required instrumentation to ensure your drug products are of the highest quality before their release.
Altasciences’ scientists apply a wide range of analytical techniques to evaluate your raw materials, APIs, and finished or in-process drug products (including Schedule I-V controlled drugs) to ensure they meet regulatory requirements. Our cGMP-compliant laboratory and manufacturing suites are located in the same facility, optimizing time between production and product release.
Our wide range of capabilities includes:
- Ultra-high performance liquid chromatography (HPLC/UPLC)
- Dissolution and disintegration testing
- Moisture analysis (gravimetric and Karl Fisher titration)
- Spectroscopy (UV/VIS/IR)
- Total organic carbon analyzer (TOC)
- Particle size analysis
- Fourier-transform infrared spectroscopy (FTIR)
Do you have a pharmaceutical product in need of release testing? Send us a message.