Analytical Methods Validation. These activities should start at least 6 months before the first batch of validation. · Validation of analytical methods : · Acetate and Trifluoroacetate content in API € [*] · Water content € [*] · GC-Headspace (complement to general method) € [*] · Direct GC (complement to general method) € [*]* · Specific rotation € [*] · Peptide content (Nitrogen) € [*] · HPLC for in-process control upstream and downstream (3 methods). Need for HPLC methods will be discussed with Radius. · HPLC for in-process control downstream : 2 methods (FG1 and VG1) € [*] each method · HPLC for in-process control upstream : 3 methods: loading € [*], short method cleavage € [*], long method cleavage € [*] LC-MS analysis by TG1 method: € [*] per sample Comparability report: € [*] Sequencing by ES/MS/CAD/MS: € [*] for 2 samples Amino acid analysis: € [*] for 2 samples Limit test for residual amino acids: € [*] for 2 samples Secondary counter ions: € [*] for 2 samples € [900]* per test sample (same method as for lot 4AI1) + $ [*] for specific method validation (Sn, Cr, Hg, Pb, As, Cd per ICH guidelines) Solubility: € [*] per test sample pH: € [*] per test sample isoelectric point: € [*] per test sample
Appears in 2 contracts
Sources: Development and Manufacturing Services Agreement (Radius Health, Inc.), Work Order (Radius Health, Inc.)