Explanation Of Peptide Drug Impurities

Peptide drug impurities refer to substances that are similar to or related to the structure of peptide components produced in the production, storage, and transportation of peptide drugs. These impurities may affect the efficacy, safety and stability of the drug, so they need to be strictly controlled. The following is information about peptide drug impurities.

Impurity classification
Process-related impurities: Directly generated during the synthesis of peptide drugs, including missing peptides, protective group residues, etc.
Degradation impurities: Produced during peptide drug storage or production due to the influence of environmental factors such as light, heat, and pH.
Genotoxic impurities: have a potential mutagenic risk, such as nitrosamines, alkyl halides, etc.
Inorganic/organic impurities: including solvent residues (such as solvents that meet ICH Q3C standards) and metal catalysts (such as palladium and nickel) residues, etc.

Source of impurities
Synthesis process: amino acid connection error, protective group residue, side reaction products, etc.
Purification process: column extractables, solvent residues, etc.
Degradation route: oxidation products, hydrolysate products, aggregates, etc.
Preparations and packaging: excipients, impurities, leachables, photothermal degradation products, etc.

Research methodology
High Performance Liquid Chromatography (HPLC) combined with mass spectrometry (MS) technology: used to analyze process-related impurities such as missing peptides, protective group residues, etc.
Stability studies combine a variety of analytical techniques for the study of degraded impurities such as oxidation products, hydrolysate products, etc.
Liquid chromatography-tandem mass spectrometry (LC-MS/MS) technique: for the detection of genotoxic impurities.
Nuclear magnetic resonance (NMR): Used to confirm the structure of unknown impurities.

Control strategy
Source control: Optimize the synthesis process and reduce impurity generation.
Process control: Monitor the synthesis reaction process in real time and establish mathematical models of key process parameters and impurity content.
Final product control: Establish reasonable impurity limit standards to ensure the safety and efficacy of drugs.
Packaging and storage: Choose appropriate packaging materials, optimize storage conditions, and reduce impurity generation.

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