Pharmaceuticals

For API's, excipients, raw material sourcing or dosage forms, for stability studies or quality control, Antellis proposes:

• Semi-quantitative screening of the periodic classification of elements (screening of 50 elements).
  
• Characterisation and quantitation of mineral impurities.
• Development and validations of methods according to the following guidelines: ICH Q2(R1), Pharm. Eur 2.2.58.
• Study/phase plans, critical inspections, final reports.

Some examples of performed analyses :

• Validation of an ICP-MS method and quantitation of Pd, Hf, Na, B, V, Ti in API's.
• Validation of an ICP-MS method and quantitation of Hf, V, Ti in dosage forms.
• Determination of mineral impurities : heavy metals, catalysts, phamacopeias metals : Al, Pb, Mo, V, Ag, Pt, Ru, Ni, Pd, Rh,…