Lanreotide impurity 4

Lanreotide Impurity 4 is a structurally related analogue generated during lanreotide synthesis or degradation. Subtle modifications influence disulfide topology, side-chain orientation, and chromatographic retention. Researchers use it as a reference standard for impurity profiling and stability assessment. Applications include process characterization, QC method validation, and peptide-variant structural comparison.

Designed for biological research and industrial applications, not intended for individual clinical or medical purposes.

CAT No: Z10-101-226

Synonyms/Alias:(4R,7S,10S,13R,16S,19R)-13-((1H-Indol-3-yl)methyl)-19-((R)-2-amino-3-(naphthalen-2-yl)propanamido)-10-(4-aminobutyl)-16-(4-hydroxybenzyl)-7-isopropyl-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosane-4-carboxylic acid

Custom Peptide Synthesis
cGMP Peptide
  • Registration of APIs
  • CMC information required for an IND
  • IND and NDA support
  • Drug master files (DMF) filing
M.F/Formula
C50H61N9O9S2
M.W/Mr.
996.2

Lanreotide impurity 4 is a synthetic peptide derivative structurally related to lanreotide, a well-known somatostatin analog. As an identified process-related impurity, this compound holds significant importance in the context of peptide pharmaceutical development and analytical quality control. Its presence and characterization are critical for ensuring the integrity, safety, and efficacy of peptide-based therapeutics. The unique structure of Lanreotide impurity 4 provides valuable insight into peptide degradation pathways, synthetic by-products, and the overall stability profile of lanreotide formulations, making it a key reference material for researchers and quality assurance professionals engaged in peptide drug development.

Analytical method development: Lanreotide impurity 4 serves as an essential reference standard in the establishment and validation of analytical methods used for the detection and quantification of impurities in lanreotide formulations. By providing a chemically defined benchmark, it enables analytical chemists to optimize separation techniques such as high-performance liquid chromatography (HPLC), mass spectrometry (MS), and related platforms. Accurate identification and quantitation of this impurity are vital for regulatory compliance and for maintaining consistent product quality across manufacturing batches.

Peptide synthesis process optimization: In peptide manufacturing, the occurrence of specific impurities can signal inefficiencies or side reactions during synthesis and purification. The availability of Lanreotide impurity 4 allows process chemists to investigate the mechanistic origins of its formation, thereby informing adjustments to synthetic protocols, reagent selection, or purification strategies. This targeted approach supports the minimization of undesired by-products and enhances the overall yield and purity of the active pharmaceutical ingredient.

Stability and degradation studies: The structural features of Lanreotide impurity 4 make it a valuable tool for forced degradation and stability-indicating studies. Researchers utilize this compound to simulate real-world storage or handling conditions, assessing how lanreotide and its formulations behave under various stressors such as heat, light, pH variation, or oxidative environments. The resulting data contribute to a thorough understanding of degradation pathways, shelf-life estimation, and the development of robust storage guidelines for peptide-based drugs.

Pharmaceutical formulation research: The inclusion of characterized impurities like Lanreotide impurity 4 in formulation studies aids in evaluating the compatibility of lanreotide with excipients and packaging materials. By monitoring the interaction of this impurity within complex matrices, formulators can identify potential risks associated with impurity migration, transformation, or accumulation over time. These insights are critical for designing stable, high-quality drug products and for meeting stringent quality assurance requirements in the pharmaceutical industry.

Structure-activity relationship investigations: The distinct molecular structure of Lanreotide impurity 4 provides researchers with a unique probe for exploring the relationship between peptide sequence alterations and biological or physicochemical properties. Comparative studies between the impurity and the parent compound can reveal how specific modifications impact receptor binding, metabolic stability, or aggregation propensity. Such research not only deepens the understanding of structure-activity relationships in somatostatin analogs but also informs the rational design of next-generation peptide therapeutics with improved profiles.

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