Description

Octreotide Impurity CAS NO 108102-47-2 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Octreotide, a synthetic peptide analog of somatostatin. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, particularly for those producing or testing somatostatin analogs and peptide-based therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in Octreotide Acetate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate stability-indicating HPLC, UPLC, or LC-MS methods for Octreotide and related peptide compounds.
• Stability Studies & Forced Degradation: Employed as a marker in stress testing studies to understand the degradation pathways and establish shelf-life specifications for Octreotide formulations.
• Quality Control & Batch Release Testing: A critical component in the quality control laboratory for routine impurity profiling to ensure every batch of Octreotide API meets pharmacopeial (USP, EP) and ICH guidelines.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Process Chemistry Optimization: Helps synthetic chemists identify and minimize the formation of this specific impurity during the peptide synthesis and purification process.

Basic Information

Product Name	Octreotide Impurity
CAS No.	108102-47-2
Molecular Formula	C₄₉H₆₆N₁₀O₁₀S₂
Molecular Weight	1019.24 g/mol
Synonyms	Octreotide Related Compound; D-Phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[(1R,2R)-2-hydroxy-1-(hydroxymethyl)propyl]-L-cysteinamide cyclic (2→7)-disulfide; SMS 201-995 Impurity; Sandostatin Impurity; (R)-2-((2R,3R)-1-((S)-2-((S)-2-((S)-2-((R)-2-((S)-2-((S)-2-Amino-3-phenylpropanamido)-3-(4-hydroxyphenyl)propanamido)-3-(1H-indol-3-yl)propanamido)-6-aminohexanamido)-3-hydroxybutanamido)-3-hydroxy-3-(1H-indol-3-yl)-2-((sulfanylmethyl)amino)propanamido)-3-hydroxybutyl)thio)acetic acid; Somatostatin Octapeptide Analog Impurity
EINECS	Contact for details

Quality Control

Every batch of Octreotide Impurity (CAS 108102-47-2) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via MS and NMR, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and related substances. Our quality commitment aligns with cGMP principles to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.