Quality Control

We have extensive experience performing analytical tests for APIsexcipientsintermediate productsfinished productspackaging materials and process environment samples. The most suitable method is used, according to customer specifications or the relevant Pharmacopoeias description (EP, USP, BP, JP). If non-compendial methods need to be used, we develop and validate the method from scratch or transfer the method from the manufacturer.

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Physical-chemical Tests:

  • General Identification Tests (IR, TLC, HPLC)
  • Assay (UV/Vis, IR, AAS, titration, HPLC by using multiple detectors, UPLC, GC, LC-MS) and dosage uniformity
  • Impurities identification (HPLC, LC-MS) 
  • Impurities determinations: degradation products, process and drug related impurities
  • Physical determinations (pH, viscosity, density, polarimetry, refraction index, melting point, osmolality)
  • Moisture (Karl Fischer, loss on drying)
  • Limit tests (heavy metals, ash, anions)
  • Residual solvents (volatile organic compounds, organic volatile impurities)
  • Elemental impurities (AAS, ICP-MS)
  • Solid oral dosage tests (disintegration, dissolution, hardness, friability) 
  • Dissolution testing (oral dosage forms)
  • Particulate matter (visible and subvisible particles)
  • In vitro release test (semisolid forms)
  • Process environment analysis (cross-contamination, rinse water from cleaning process, swabbing surfaces)

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