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Retatrutide impurity analysis
Release time：
2025-07-21
Retatrutide is a novel triple receptor agonist (GLP-1/GIP/GCGR). Its impurities refer to substances with different structures from the target molecule produced during synthesis, storage, or use, which may affect safety and stability. The main sources of impurities include:
I. Definition and Sources of Impurities
Retatrutide is a novel triple receptor agonist (GLP-1/GIP/GCGR). Its impurities refer to substances with different structures from the target molecule produced during synthesis, storage, or use, which may affect safety and stability. The main sources of impurities include:
Synthesis process: In solid-phase synthesis, incomplete amino acid condensation, removal of protecting groups, or side reactions (such as racemization) may introduce impurities.
Starting materials: Insufficient purity of raw materials or the presence of isomers (such as D-amino acids) may lead to residual impurities.
Storage conditions: High temperature, light, or oxidizing environments may cause degradation (such as peptide bond breakage, oxidation).
II. Common Impurity Types and Characteristics
Structural Modification Impurities
[Double-Phe22] Retatrutide Impurity: The 22nd phenylalanine (Phe) is repeatedly inserted, possibly due to amino acid addition errors during synthesis.
[D-Ser33] Retatrutide Impurity: The 33rd serine (Ser) undergoes epimerization, caused by chiral inversion during synthesis or degradation.
Characteristics: This type of impurity may alter receptor binding ability.
Degradation Products
Chain Scission Products: Peptide bond hydrolysis leads to molecular fragmentation, such as complete hydrolysis of asparagine (Asn) or succinimide intermediates.
Oxidized Impurities: Sulfur-containing amino acids (such as cysteine) are oxidized to form disulfide bonds or sulfonic acid derivatives.
Process-Related Impurities
Residual Solvents: Solvents used in synthesis (such as DMF, DMSO) are not completely removed.
Metal Catalysts: Residual metals such as palladium and nickel used in solid-phase synthesis.
Characteristics: Must comply with ICH guidelines (such as Q3C, Q3D) for residue requirements.
III. Impurity Control Strategy
Synthesis Process Optimization
Use raw materials and strictly control reaction conditions (temperature, pH, time).
Use orthogonal protecting group strategies to reduce side reactions, such as reducing the risk of racemization through Fmoc/tBu solid-phase synthesis.
Purification Technology
Liquid Chromatography (HPLC): Using a reversed-phase C18 column to separate the target peptide from impurities, with purity reaching over 99%.
Ion Exchange Chromatography: Separates charged impurities (such as oxidation products) based on charge differences.
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