Description

Palonosetron Impurity 9 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 utilized by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Palonosetron Impurity 9 in active pharmaceutical ingredients (API) and finished drug products.
• Method Development & Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor impurity levels during the manufacturing process and in final drug substance batches.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to establish impurity profiles and justify specification limits.
• Research & Development: Aids in synthetic route optimization and impurity fate and tolerance studies during the drug development process.

Basic Information

Product Name	Palonosetron Impurity 9
CAS No.	2216755-75-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palonosetron Related Compound 9; Palonosetron EP Impurity I; Palonosetron USP 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 Degradation Product; Palonosetron Process Impurity
EINECS	Contact for details

Quality Control

Our Palonosetron Impurity 9 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, GC, MS, and NMR 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 cGMP principles for pharmaceutical reference standards.

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 and handled with appropriate laboratory safety precautions to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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