Description

Octreotide Impurity CAS NO 1546983-16-7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Octreotide, a synthetic peptide analog of somatostatin used in therapeutic applications. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of well-characterized impurities is essential for meeting stringent pharmacopeial standards and regulatory compliance in drug development.

Application

• Pharmaceutical Quality Control (QC): Used as a reference standard for the identification and quantification of this specific impurity in Octreotide Acetate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating stability-indicating HPLC or UPLC methods for Octreotide.
• Stability Studies: Employed to monitor the formation of degradation products during forced degradation and long-term stability studies of Octreotide formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemical behavior of the Octreotide molecule.
• Calibration Standard: Acts as a calibrant for ensuring the accuracy and precision of analytical instruments used in impurity profiling.

Basic Information

Product Name	Octreotide Impurity
CAS No.	1546983-16-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Octreotide Related Compound; Octreotide Degradant; Octreotide Process Impurity; Somatostatin Analog Impurity; (CAS 1546983-16-7); 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 (Impurity of Octreotide); Sandostatin Impurity
EINECS	Contact for details

Quality Control

Every batch of Octreotide Impurity (CAS 1546983-16-7) is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability. For long-term storage, consider conditions recommended for peptide-based compounds.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with 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 Q3C guidelines

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