Description

Octreotide Non-Cyclic System Suitability Marker (20 Mg) (Cold Shipment Required) is a high-purity analytical reference standard specifically designed for chromatographic system suitability testing. This compound is critical for ensuring the performance, resolution, and reproducibility of analytical methods, particularly in the quality control of peptide pharmaceuticals. It is an essential tool for pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in method validation and regulatory compliance. The product requires cold chain logistics to maintain its stability and integrity during transport.

Application

• Chromatographic System Suitability Testing: Primary standard for verifying the performance of HPLC and UHPLC systems in peptide analysis.
• Pharmaceutical Quality Control (QC): Used as a critical reference marker in the assay and impurity profiling of Octreotide acetate and related somatostatin analog drug substances and products.
• Analytical Method Development and Validation: Serves as a key component in developing, optimizing, and validating stability-indicating methods for regulatory submissions (e.g., FDA, EMA).
• Pharmacopeial Testing: Applicable for testing procedures aligned with USP, EP, or other pharmacopeial monographs for peptide-based therapeutics.
• Contract Laboratory Services: Essential reference material for CROs and testing labs providing outsourced analytical services to the biopharma industry.
• Research and Development: Used in R&D settings for the structural elucidation and comparative analysis of synthetic peptides.

Basic Information

Product Name	Octreotide Non-Cyclic System Suitability Marker (20 Mg) (Cold Shipment Required)
CAS No.	774239-80-4
Molecular Formula	C49H66N10O10S2
Molecular Weight	1019.24 g/mol
Synonyms	Octreotide Open-Chain Impurity; Octreotide System Suitability Marker; Octreotide Non-Cyclic Related Substance; Desmopressin System Suitability Marker EP; (2-Mercaptopropionyl)-D-Phe-Cys-Phe-D-Trp-Lys-Thr-Cys-Thr-ol; Linear Octreotide; Octreotide EP Impurity C; Octreotide USP Resolution Mixture Component
EINECS	Contact for details

Quality Control

This high-grade reference standard is manufactured under controlled conditions and undergoes rigorous analytical characterization using techniques including HPLC, mass spectrometry, and NMR to confirm identity and purity. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing assay, purity, and chromatographic performance data. Our quality system is designed to support cGMP and ISO 9001 compliance for our customers in regulated industries.

Storage

Preserve in a tightly closed container, protected from light. Store frozen at or below -20°C. This product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a dry environment before opening to prevent condensation and moisture uptake.

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%
Water Content (KF)	≤ 5.0%
Chromatographic Performance	Suitable for system suitability test as per defined method

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