Description

Palonosetron Impurity is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of Palonosetron hydrochloride, a potent antiemetic drug, by serving as a marker for identification and quantification of related substances. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on pharmaceutical impurity profiling and regulatory compliance.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of this specific impurity in Palonosetron hydrochloride Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch testing within pharmaceutical manufacturing to ensure product purity meets stringent pharmacopeial standards (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to monitor the formation of degradation products in Palonosetron formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive understanding and control of the drug substance's impurity profile.
• Research and Development: Facilitates studies on the synthesis pathway, degradation mechanisms, and toxicological profiling of Palonosetron-related compounds.

Basic Information

Product Name	Palonosetron Impurity
CAS No.	2216746-63-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palonosetron Related Compound; Palonosetron Hydrochloride Impurity; (3aS)-2-[(3S)-1-Azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4-tetrahydro-1H-benz[de]isoquinolin-1-one Impurity; Palonosetron Process Impurity; Aloxi Impurity; RS-25259-197 Impurity; 1H-Benz[de]isoquinolin-1-one, 2,3,3a,4-tetrahydro-2-[(3S)-1-azabicyclo[2.2.2]oct-3-yl]-, (3aS)- (Impurity Form)
EINECS	Contact for details

Quality Control

Every batch of our Palonosetron Impurity (CAS 2216746-63-1) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, aligning with ICH Q3A/B guidelines for impurities in new drug substances and products. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques. Our commitment to GMP-grade standards ensures reliability for your most critical pharmaceutical development and compliance work.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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