Description

Octreotide Impurity CAS NO 1546983-18-9 is a high-purity chemical reference standard used for the analytical profiling and quality control of Octreotide, a critical synthetic peptide pharmaceutical. This impurity is essential for pharmaceutical manufacturers and analytical laboratories to ensure the safety, efficacy, and regulatory compliance of Octreotide drug substances and products. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and impurity identification studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Octreotide Acetate API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles throughout the drug lifecycle.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to confirm that Octreotide batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed as a marker to track the formation of degradation products under various stress conditions (e.g., heat, light, pH) during drug stability testing.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval and market authorization.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis and purification processes of Octreotide to minimize impurity formation.

Basic Information

Product Name	Octreotide Impurity
CAS No.	1546983-18-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Octreotide Related Compound; Octreotide Impurity Standard; Octreotide Degradant; Octreotide Process Impurity; Somatostatin Analog Impurity; (CAS 1546983-18-9); Octreotide Acetate Impurity
EINECS	Contact for details

Quality Control

Every batch of Octreotide Impurity (CAS 1546983-18-9) is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing the results against established specifications. Our quality commitment aligns with cGMP principles and supports compliance with ICH guidelines for impurities in new drug substances.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle the container with care to minimize exposure to atmospheric humidity during use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specified limits
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.