Description

Palonosetron Impurity 24 is a designated impurity standard used in the analytical profiling and quality control of the antiemetic drug Palonosetron. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development, process validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Palonosetron HCl API and finished drug products.
• Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in accordance with ICH guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels and ensure batches meet stringent pharmacopeial specifications (USP, EP).
• Stability Studies: Acts as a critical marker in forced degradation and long-term stability studies to track impurity formation over time.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Research & Development: Utilized in synthetic route optimization and process chemistry to understand and control impurity formation.

Basic Information

Product Name	Palonosetron Impurity 24
CAS No.	83721-32-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palonosetron Related Compound 24; Palonosetron EP Impurity 24; Palonosetron USP Impurity 24; (3aS)-2-[(1R,5S)-8-Methyl-8-azabicyclo[3.2.1]oct-3-yl]-2,3,3a,4-tetrahydro-1H-pyrrolo[3,2-c]quinolin-1-one; Palonosetron Impurity; Palonosetron Degradant
EINECS	Contact for details

Quality Control

Our Palonosetron Impurity 24 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic confirmation (NMR, MS), to ensure identity, strength, and composition. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality assurance requirements.

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) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

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
Water Content (KF)	≤ 5.0%

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