State-of-the-art chromatography, mass spectrometry, spectroscopy, and thermal analysis driven by automated CDS systems and audit trails.
High-performance liquid chromatography for assay, related substances, stability testing, and routine QC analysis.
Gas chromatography coupled with mass spectrometry for residual solvents, fatty acid profiling, and volatile analysis.
Triple quadrupole mass spectrometry for sub-ppb nitrosamine quantitation, trace impurity identification, and PK bioanalysis.
Inductively coupled plasma mass spectrometry for elemental impurities (USP <232>/<233>) and trace heavy metals analysis.
Fourier-transform infrared spectroscopy with ATR attachment for raw material fingerprinting and polymer identification.
Quantitative spectrophotometric assays, extinction coefficient determination, and colorimetric concentration checks.
Total Organic Carbon testing for Purified Water, Water for Injection (USP <643>), and cleaning validation swab samples.
Laser diffraction particle size distribution (PSD d10, d50, d90) for powder APIs, suspensions, and emulsions.
Powder X-ray diffraction for API polymorph identification, crystallinity percentage, and phase purity determination.
Differential Scanning Calorimetry and Thermogravimetric Analysis for glass transition, melting point, and thermal degradation.
Comprehensive physicochemical and microbiological analysis of Purified Water, WFI, and process water as per APHA Standard Methods, IP, and USP <1231> — including pH, conductivity, TOC, heavy metals, nitrates, and microbial limits.
ICH Q1A/Q1B-guided accelerated, intermediate, and long-term stability testing for drug products and APIs under controlled temperature and humidity conditions — supporting shelf-life determination and regulatory submissions.
