Method Development and Validation

PolyCrystalLine provides the development of analytical methods for the following applications:

• Quality assessment of APIs, starting material and final product
• Characterization of APIs
• Quantity assessment of APIs and formulated APIs

ICH Validation

The methods developed are validated for testing scientific integrity following ICH guidelines, including preparation and validation protocols and reports.

Method Transfer

PolyCrystalLine provides and follows the transfer of the method developed where it is needed to perform the analyses within our company.

Quality assessment XRD, TGA, DSC, FT-IR, HPLC, FT-Raman, s.s.N.M.R., PSD
Quantity assessment XRD, FT-IR, s.s.N.M.R., DSC and FT-Raman
Dissolution Ph. Eur. 2.9.3