A product may also be medicinal when it is intended to restore, correct or modify a physiological function through pharmacological, immunological or metabolic action
Prausnitz, M
[DOI] [PubMed] [Google Scholar] 5.Kang D, Shi B, Erfe MC, Craft N, Li H
What a Meaningful DSIP Certificate of Analysis Should Include Full emideltide name and WAGGDASGE sequence Declared free-base or acetate form Confirmation of terminal groups Observed intact molecular mass Tandem-MS sequence evidence Quantitative net peptide assay Chromatographic purity Named and unknown related-substance results Acetate result where applicable Water-content result Residual-solvent results Aggregate or higher-molecular-weight-species assessment Bacterial-endotoxin result where relevant Microbiological testing where relevant Finished-product batch number Testing-laboratory identity Analytical methods and acceptance criteria A clear list of tests not performed Why 99% HPLC Is Not Enough A single chromatographic percentage does not prove the complete sequence, correct salt form, net peptide content, aggregate level, degradation profile, endotoxin control or microbiological quality
Chen, I.-T., Hsu, P.-H., Hsu, W.-C., Chen, N.-J
