Description

Palonosetron Impurity 11 is a designated impurity standard used in the analytical profiling and quality control of the antiemetic drug Palonosetron. This high-purity reference material is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily required by professionals in pharmaceutical R&D and quality assurance for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Palonosetron Impurity 11 in active pharmaceutical ingredients (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in compliance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels and ensure batches meet stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) during drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Palonosetron Impurity 11
CAS No.	2216753-67-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palonosetron Related Compound 11; (3aS)-2-[(3S)-1-Azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4-tetrahydro-1H-benz[de]isoquinolin-1-one (specific isomer); Palonosetron Process Impurity; Palonosetron Degradant; Aloxi Impurity 11
EINECS	Contact for details

Quality Control

Our Palonosetron Impurity 11 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality commitment aligns with the standards required for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment. For long-term storage, consider conditions recommended for labile organic compounds.

Specification

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

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