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Key points analysis of Tirzepatide impurities
Release time：
2025-08-10
I. Tirzepatide Basic Information Tirzepatide is a linear peptide composed of 39 amino acids with the molecular formula C₂₂₅H₃₄₈N₄₈O₆₈ and a molecular weight of 4813.45 Da. II. Impurity Sources and Classification Impurities in tirzepatide mainly come from the following aspects: Production process impurities Synthetic residues: including unreacted amino acids, protecting groups (such as Fmoc, Boc), catalysts (such as EDTA, TCEP), and solvent residues. Degradation products: During synthesis, purification, or storage, reactions such as peptide bond breakage, oxidation (such as methionine oxidation), deamidation (such as asparagine deamidation) may generate impurities. Exogenous contamination: Metal ions (such as sodium, potassium), microbial metabolites from production equipment, containers, or the environment
Tirzepatide is a linear peptide composed of 39 amino acids, with the molecular formula C₂₂₅H₃₄₈N₄₈O₆₈ and a molecular weight of 4813.45 Da.
II. Impurity Sources and Classification
The impurities of Tirzepatide mainly come from the following aspects:
Production process impurities
Synthesis residues: including unreacted amino acids, protecting groups (such as Fmoc, Boc), catalysts (such as EDTA, TCEP), and solvent residues.
Degradation products: During synthesis, purification, or storage, reactions such as peptide bond breakage, oxidation (e.g., methionine oxidation), and deamidation (e.g., asparagine deamidation) may generate impurities.
Exogenous contamination: Metal ions (such as sodium, potassium), microbial metabolites, etc. from production equipment, containers, or the environment.
Storage and transportation impurities
Environmental factors: Changes in light, temperature, humidity, or pH may induce Tirzepatide degradation, generating impurities such as [β-Asp15] Tirzepatide (Asp15 isomerization).
III. Impurity Detection Methods
Reversed-phase high-performance liquid chromatography (RP-HPLC)
Mobile phase: Acidic aqueous solution (phase A).
Stationary phase: C18 column or ethylene-bridged hybrid particles (HILIC column).
Detector: Ultraviolet detector (UV), wavelength usually set to 210-220 nm (peptide bond absorption peak).
Advantages: Can separate most process impurities, detection limit as low as ppm/ppb level.
Liquid chromatography-mass spectrometry (HPLC-MS)
Used to identify the structure of unknown impurities, and determine the source of impurities through mass spectrometry fragment analysis (such as oxidation site, deamidation position).
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