We wish to buy 10g of tacrolimus monohydrate for a clinical investigation. We will need all the documentation necessary to complete an investigational medicinal products dossier: rn2.2.1.S Drug substance 8rn2.2.1.S.1 General Information 8rn2.2.1.S.1.1 Nomenclature 8rn2.2.1.S.1.2 Structure 8rn2.2.1.S.1.3 General properties 8rn2.2.1.S.2 Manufacture 9rn2.2.1.S.2.1 Manufacturer 9rn2.2.1.S.2.2 Description of manufacturing process and process controls 9rn2.2.1.S.3 Control of materials 10rn2.2.1.S.2.4 Control of critical steps and intermediates 10rn2.2.1.S.2.5 Process validation and/or evaluation 10rn2.2.1.S.2.6 Manufacturing process development 10rn2.2.1.S.3 Characterisation 10rn2.1.2.S.3.1 Elucidation of structure and other characteristics 10rn2.1.2.S.3.2 Impurities 10rn2.2.1.S.4 Control of the drug substance 10rn2.2.1.S.4.1 Specification 10rn2.2.1.S.4.2 Analytical procedures 10rn2.2.1.S.4.3 Validation of analytical procedures 10rn2.2.1.S.4.4 Batch analyses 10rn2.2.1.S.4.5 Justification of specification 11rn2.2.1.S.5 Reference standards or materials 11rn2.2.1.S.6 Container closure system 11rn2.2.1.S.7 Stability 11rn