Description

Octreotide Impurity CAS NO 1546983-33-8 is a high-purity chemical reference standard used in the analytical profiling and quality control of Octreotide, a critical synthetic peptide pharmaceutical. This impurity is essential for pharmaceutical manufacturers and research laboratories to ensure the safety, efficacy, and regulatory compliance of their products by accurately identifying and quantifying related substances. It is primarily utilized by professionals in pharmaceutical development, quality assurance (QA), and quality control (QC) departments for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Octreotide Acetate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating high-performance liquid chromatography (HPLC) and other chromatographic methods used in purity analysis.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines, ensuring every batch meets stringent specifications.
• Stability Studies: Employed to track the formation of degradation products in Octreotide formulations under various stress conditions (e.g., heat, light, humidity) over time.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research & Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis and purification processes for Octreotide.

Basic Information

Product Name	Octreotide Impurity
CAS No.	1546983-33-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Octreotide Related Compound; Octreotide Impurity Standard; Octreotide Process Impurity; Octreotide Degradant; Somatostatin Analog Impurity; (CAS 1546983-33-8); 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)
EINECS	Contact for details

Quality Control

Our Octreotide Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via mass spectrometry (MS) and/or nuclear magnetic resonance (NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality requirements.

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. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
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 Q3C guidelines

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