Production support is provided through in-process and intermediate testing, and rigorous ﬁnal product release testing is undertaken. Our fully qualiﬁed analytical laboratories at our Pilot, GMP plant comply with cGMP standards. Additionally, stability testing and degradation studies are performed following ICH Q1A (R2) guidelines.
Our services include full analytical provision for regulatory ﬁling purposes, including method development, validation, and reference standard qualiﬁcation.
Soneas Chemicals Ltd continues to invest in additional analytical capability to support our growing synthetic capacity.
Analytical support equipments:
- Fully qualified cGMP analytical laboratory
- FT-IR spectrophotometer
- UV-VIS spectrophotometer
- GC-FID (headspace sampler)
- Titrators, Karl-Fischer titrators
- Sulphated Ash
- HPLC (Corona detectors)
- NMR Spectrometer (Bruker 500MHz Ultrashield)
- Stability chambers