Moravek offers analytical method transfer services as part of your GMP 14C-labeled active pharmaceutical ingredient (API) manufacturing campaign. We offer both achiral and chiral HPLC and UHPLC method transfer services to suit a wide variety of projects.
Our HPLC and UHPLC method transfer services are performed by highly trained and experienced laboratory staff and are compliant with USP <1224> under Revalidation; i.e., the method transfer will consist of partial revalidation by the receiving laboratory. We offer two options for method transfer services, as described below, to provide flexibility based on your needs.
GMP analytical method transfer service options are:
- Option A) Demonstration of Method Performance Suitability, Customer Derived Documentation
Description: Limited in nature to the evaluation of system suitability, repeatability, related compounds and Limit Of Quantitation. Customer writes or provides an analytical method transfer demonstration protocol and analytical transfer demonstration report. - Option B) Demonstration of Method Performance Suitability, Moravek Derived Documentation
Description: Limited in nature to the evaluation of system suitability, repeatability, related compounds and Limit Of Quantitation. Moravek writes or provides an analytical method transfer demonstration protocol and analytical transfer demonstration report. - Option C) Full HPLC Method Transfer, Customer Derived Documentation
Description: Evaluation of system suitability, linearity, repeatability, reproducibility, Limit Of Quantitation, Limit Of Detection, and related compounds. Customer writes or provides an analytical method transfer demonstration protocol and analytical transfer demonstration report. - Option D) Full HPLC Method Transfer, Moravek Derived Documentation
Description: Evaluation of system suitability, linearity, repeatability, reproducibility, Limit Of Quantitation, Limit Of Detection, and related compounds. Moravek writes or provides an analytical method transfer demonstration protocol and analytical transfer demonstration report.