Description

Octreotide Impurity CAS NO 83679-71-4 is a critical reference standard used in the pharmaceutical development and quality control of Octreotide, a synthetic peptide analog of somatostatin. This impurity is essential for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and validation of peptide-based therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Octreotide Acetate API and finished drug products.
• Analytical Research: Used in HPLC, UPLC, and LC-MS studies for the identification, characterization, and quantification of process-related impurities and degradation products.
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity profiles and stability data to meet ICH guidelines (Q3A, Q3B).
• Process Development & Optimization: Aids in monitoring and controlling impurity formation during the synthesis, purification, and scale-up of Octreotide.
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of Octreotide.

Basic Information

Product Name	Octreotide Impurity
CAS No.	83679-71-4
Molecular Formula	C49H66N10O10S2
Molecular Weight	1019.24 g/mol
Synonyms	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; Octreotide Related Compound; Octreotide EP Impurity; Octreotide USP Impurity; Somatostatin Analog Impurity; (R)-2-((2R,5S,8S,11S,14R,17S)-11-((S)-sec-butyl)-14-((R)-1-hydroxyethyl)-5,8-diisopropyl-2,17-dimethyl-4,7,10,13,16-pentaoxo-3,6,9,12,15-pentaazaoctadecan-18-yl)-3-phenylpropanoic acid (IUPAC-style descriptor).
EINECS	Contact for details

Quality Control

Our Octreotide Impurity is manufactured under strict quality systems suitable for pharmaceutical reference standards. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure compliance with relevant pharmacopeial guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided, supporting traceability and regulatory 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. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

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%
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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