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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

2490269-78-6Semaglutide Impurity 128

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Catalogue No.:	VE0025930
CAS No.:	2490269-78-6
Mol. Formula:	C27H32N2O7
Mol. Weight:	496.6 g/mol

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Additional information on CAS 2490269-78-6

Parent drug

Semaglutide

IUPAC Name

Tert-butyl (4S)-4-(9H-fluoren-9-ylmethoxycarbonylamino)-5-[(2-methoxy-2-oxoethyl)amino]-5-oxopentanoate

Pharmacopeial Synonyms

N/A

Synonyms

N/A

Smiles

CC(C)(C)OC(=O)CC[C@@H](C(=O)NCC(=O)OC)NC(=O)OCC1C2=CC=CC=C2C3=CC=CC=C13

InChI

InChI=1S/C27H32N2O7/c1-27(2,3)36-23(30)14-13-22(25(32)28-15-24(31)34-4)29-26(33)35-16-21-19-11-7-5-9-17(19)18-10-6-8-12-20(18)21/h5-12,21-22H,13-16H2,1-4H3,(H,28,32)(H,29,33)/t22-/m0/s1

Description

Semaglutide Impurity 128 (CAS 2490269-78-6) is a process-related variant encountered during semaglutide synthesis, characterized by a specific mass shift and retention behavior in reversed-phase HPLC. Robust analytical characterization using LC-MS, high-resolution MS and 1H/13C NMR enables structural elucidation and quantitation for impurity profiling. Understanding formation pathways, hydrolytic or side-chain modification risks, and stability under formulation conditions informs control strategies and specification setting. Accurate reference material and validated methods are essential for regulatory compliance and batch release, ensuring drug substance purity and minimizing impact on pharmacopoeial acceptance and downstream quality attributes.