SCOPE

This general chapter is intended to provide recommendations  on the minimum quality attributes for starting materials used in the manufacture of synthetic therapeutic peptides. Because it is not possible to cover the wide variety of available starting materials that may be used, including amino acids, protected amino acid derivatives, and peptide fragments, the discussion in this chapter will be limited to the most commonly used protected amino acid derivatives (AAD), i.e., 9-fluorenylmethyloxycarbonyl (Fmoc) amino acid derivatives (including resin-bound AAD). However, it is intended that the general concepts and guidance provided for this class of starting materials should be applied to all peptide starting materials, where applicable. This chapter is to be used in conjunction with Quality Attributes of Synthetic Peptide Drug Substances 〈1503〉.