Description

Palonosetron Impurity 22 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 used by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Palonosetron Impurity 22 in active pharmaceutical ingredients (API) and finished drug products.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels and ensure batches of Palonosetron HCl meet stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Palonosetron formulations.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA and EMA.
• Research and Development: Serves as a critical tool in process chemistry to understand and control impurity formation during the synthesis and purification of Palonosetron.

Basic Information

Item	Detail
Product Name	Palonosetron Impurity 22
CAS No.	1217547-14-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palonosetron Related Compound 22; Palonosetron EP Impurity 22; Palonosetron USP Impurity 22; (3aS)-2-[(1R,5S,6s)-6-(Acetylamino)-3-azabicyclo[3.2.0]hept-3-yl]-2,3,3a,4-tetrahydro-1H-benz[de]isoquinolin-1-one; 1H-Benz[de]isoquinolin-1-one, 2,3,3a,4-tetrahydro-2-[(1R,5S,6s)-6-(acetylamino)-3-azabicyclo[3.2.0]hept-3-yl]-, (3aS)-; Palonosetron Impurity F (Potential); Palonosetron Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Palonosetron Impurity 22 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated methods such as HPLC, NMR, and MS to ensure compliance with pharmacopeial and internal specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 must be kept in a desiccated environment to maintain stability and purity. Handle with appropriate precautions in a well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
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.