Validation and Qualification

• Analytical Method Validation Report 6N HCl in IPA

• Analytical Method Validation Report Determination of Elemental Impurities in MES Sodium and HEPES Sodium by ICP-MS

• Analytical Method Validation Report DNase (Endonuclease) Assay

• Analytical Method Validation Report DNase (Exonuclease) Assay

• BioSpectra Third Street Facility Preliminary Warehouse Mapping Study

• Cysteamine HCl 2-MEA External Validation Report Process Suite N05

• Cysteamine HCl 2-MEA External Validation Report Process Suite N05 (2)

• Elemental Impurity Assessment_MOPS 2022 Validation

• External Validation Report 6N HCl in IPA

• Guanidine HCl 6M Solution External Validation Report

• Guanidine Hydrochloride Bio Excipient Validation Report

• Guanidine Thiocyanate Bio Excipient Grade Revalidation Report

• HEPES BioSpectra External Validation Report

• HEPES Filter Validation Report

• HEPES Free Acid BioSpectra Validation Report Hepes Raw Material Manufacturing Line and Packaging

• MES Analytical Method Validation Report

• MES Monohydrate Bio Excipient Validation Report

• MES Monohydrate Revalidation Report

• MOP Bio Excipient Grade Revalidation Report

• MOPS Bio Excipient Suite 1 Equivalency Report

• Sodium Decanoate External Validation Report

• Sodium Decanoate NDEC-3200 or Below Grade Validation Report

• Tris HCl External Validation Report

• Tris Hydrochloride Bio Excipient Grade External Validation Report Bangor M11

• Tris Hydrochloride Bio Excipient Grade External Validation Report Stroudsburg

• Tris Hydrochloride External Validation Report 2022 - Stroudsburg

• Uracil Assay Validation Report GMP

• Uracil External Validation Report for URAC-4202

• Uracil URAC 4202 External Validation Report