Description

Octreotide Impurity CAS NO 87759-89-5 is a high-purity chemical reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient (API) Octreotide. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure the safety, efficacy, and regulatory compliance of their products. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and contract research organizations (CROs) for method development, validation, and stability studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of related substances in Octreotide acetate API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurities during manufacturing.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to ensure drug substance and product purity meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Aids in understanding the degradation pathways and chemical behavior of the Octreotide molecule during synthesis and formulation.

Basic Information

Item	Details
Product Name	Octreotide Impurity
CAS No.	87759-89-5
Molecular Formula	C₄₉H₆₆N₁₀O₁₀S₂
Molecular Weight	1019.24 g/mol
Synonyms	D-Phenylalanyl-L-cystyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[(1R,2R)-2-hydroxy-1-(hydroxymethyl)propyl]-L-cysteinamide cyclic (2→7)-disulfide; Octreotide Related Compound; Octreotide EP Impurity; Octreotide USP Impurity; Somatostatin analog impurity; SMS 201-995 impurity
EINECS	Contact for details

Quality Control

Every batch of Octreotide Impurity is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified criteria.

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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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