Analytical Methods Validation Sample Clauses

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 € 12,000 · Water content € 5,000 · GC-Headspace (complement to general method) € 12,000 · Direct GC (complement to general method) € 12,000 · Specific rotation € 3,000 · Peptide content (Nitrogen) € 6,000 · 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) € 3,000 each method · HPLC for in-process control upstream : 3 methods: loading € 4,000, short method cleavage € 6,000, long method cleavage € 8,000 · LCMS comparability: LC-MS analysis by TG1 method: € 800 per sample Comparability report: € 500 · reference standard [assuming 2 lots and 250mg of each minimum] Sequencing by ES/MS/CAD/MS: € 3000 for 2 samples Amino acid analysis: € 1600 for 2 samples Limit test for residual amino acids: € 1600 for 2 samples Secondary counter ions: € 1000 for 2 samples · Heavy metals (USP/EP level) € 900 per test sample (same method as for lot 4AI1) + $ 22,500 for specific method validation (Sn, Cr, Hg, Pb, As, Cd per ICH guidelines) · General properties: Solubility: € 175 per test sample pH: € 150 per test sample isoelectric point: € 275 per test sample

Analytical Methods Validation. 1. AUXILIUM shall be responsible at its cost for analytical methods validation for drug substance and drug product.