The semaglutide impurity endo-14a-Glu-SMT is a structurally related impurity that may be produced during the synthesis or degradation of semaglutide (a long-acting GLP-1 receptor agonist used to treat type 2 diabetes and obesity). This impurity is formed by the substitution of glutamic acid (Glu) at a specific site (14a), and its presence may affect the chemical purity, conformational stability and pharmacological activity of the drug. According to the requirements of the ICH Q3A/B guidelines, analytical methods such as high-performance liquid chromatography (HPLC-MS) are required to strictly control the process impurities qualitatively and quantitatively to ensure that its content is below the threshold of toxicological concern (TTC) to meet the drug quality standards and clinical safety requirements.
Product Overview
Basic Description |
Structure and function: |
Three-letter sequence |
H-His-Ala-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu-Gly-Gln-Ala-Lys-Glu-Ile-Trp-Leu-Val-Lys-Gly-Asp-Val-Arg-Arg-Arg-Arg-Arg-Arg-Gly-CONH2 |
Single letter sequence |
HHAEGTFTSDVSSYLEGQAKEITWLVLVKGDVRRAARRRRG-NH2 |
Molecular formula |
C187H290N54O59S |
Molecular weight |
4106.14 g/mol |
Product Attributes
purity |
>98% |
form |
Lyophilized powder |
Storage conditions |
Store at -20°C/-80°C away from light |