Description

Palonosetron Impurity 8 is a designated impurity standard used in the analytical profiling and quality control of the antiemetic drug Palonosetron hydrochloride. This high-purity reference material is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is essential for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Palonosetron API and finished drug products.
• Method Development & Validation (HPLC/LC-MS): Critical for developing, validating, and verifying chromatographic methods to separate and detect Palonosetron Impurity 8.
• Stability Indicating Method: Used in forced degradation and long-term stability studies to monitor the formation of this impurity over time and under various stress conditions.
• Quality Control & Batch Release: Employed in routine QC testing to ensure batches of Palonosetron hydrochloride meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Palonosetron, supporting formulation optimization.

Basic Information

Item	Detail
Product Name	Palonosetron Impurity 8
CAS No.	2216755-70-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palonosetron Related Compound 8; Palonosetron EP Impurity I; Palonosetron Hydrochloride Impurity 8; (3aS)-2-[(3S)-1-Azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4-tetrahydro-1H-benz[de]isoquinolin-1-one; UNII-9F6W0N6ZCK; 1H-Benz[de]isoquinolin-1-one, 2-[(3S)-1-azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4-tetrahydro-, (3aS)-
EINECS	Contact for details

Quality Control

Our Palonosetron Impurity 8 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination, identity confirmation by spectroscopic methods (IR, NMR, MS), and control of related substances. A comprehensive Certificate of Analysis (COA) is supplied with each lot, providing batch-specific data. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.