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
• DSC
• FT-IR spectrophotometer
• UV-VIS spectrophotometer
• GC-FID (headspace sampler)
• Titrators, Karl-Fischer titrators
• Sulphated Ash
• Polarimeter
• LC-MS
• HPLC (Corona detectors)
• UHPLC
• NMR Spectrometer (Bruker 500MHz Ultrashield)
• PowerXRD
• Stability chambers
• ICP-OES