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Onyx Scientific provides an independent and comprehensive range of analytical chemistry services including:
- Pharmacopoeial testing of raw materials and finished products to required specifications (e.g. USP, BP, EP)
- Release testing
- Residual solvent analysis (Headspace analysis (GC))
- Method development
- Method validation
- Expert spectroscopy services
- Impurity profiling and identification
- GC
- LC
- LC-MS
- NMR
- FT-IR
- UV-Vis
- Thermal transition measurements (DSC)
- Karl Fischer water analysis
- Loss on Drying
- Autotitration
- Residue on ignition (sulphated ash)
Stability Studies
In-house long-term and accelerated stability services for API, formulation and excipient compatibility are offered. Services are run to ICH guidelines under the following conditions:
25oC/60% Relative Humidity
30oC/65% Relative Humidity
40oC/70% Relative Humidity
Each unit is continuously monitored and staff are on a 24hr callout should a unit fall outside the set ranges. Typical analysis methods include LC, GC, KF and DSC.
Thermal transition measurements (DSC)
Differential Scanning Calorimetry is used to measure purity, degree of crystallinity, glass transition temperature and specific heat capacity in addition to generating information on reaction, product or solution hazards.
LC
Detector mode is either diode array (UV) or Evaporative Light Scattering (ELS)
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