Description

Octreotide Impurity CAS NO 191806-77-6 is a high-purity reference standard used for the analytical characterization and quality control of the pharmaceutical peptide Octreotide. This impurity is critical for ensuring the safety and efficacy of Octreotide-based drug products by enabling precise identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory affairs departments focused on method development, validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods in drug substance and drug product analysis.
• Method Development & Validation: Used to develop, optimize, and validate analytical procedures for impurity profiling of Octreotide Acetate API and its formulations.
• Quality Control & Batch Release: Critical for establishing impurity limits, conducting stability studies, and ensuring batch-to-batch consistency in manufacturing.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing identified impurity data.
• Stability Indicating Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, pH).
• Pharmacopeial Testing: Used as a system suitability standard to comply with testing requirements outlined in USP, EP, or other pharmacopeias.

Basic Information

Product Name	Octreotide Impurity
CAS No.	191806-77-6
Molecular Formula	C49H66N10O10S2
Molecular Weight	1019.24 g/mol
Synonyms	Octreotide Related Compound; 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; (2R,7R)-N-[(2R)-2-Hydroxy-1-[(2R)-2-[[(2S)-2-[[(2S)-2-[[(2R)-2-[[(2S)-2-Amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-3-(1H-indol-3-yl)propanoyl]amino]-5-carbamimidamidopentanoyl]amino]-3-(1H-indol-3-yl)propanoyl]-1,2-dithia-5,8,11,14,17-pentaazacycloicosane-4,7,10,13,16-pentaone; Octreotide Impurity Standard; Octreotide Acetate Impurity.
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, LC-MS for structural confirmation, and NMR for identity verification, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and can be tailored to support specific pharmacopeial (USP/EP) or internal method 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. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 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.