Description

Palonosetron Impurity 12 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 in research and development, method validation, and stability studies for Palonosetron hydrochloride formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Palonosetron Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to monitor impurities during the manufacturing process.
• Stability Indicating Method: Used in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Quality Control & Batch Release: A critical component in the QC laboratory for routine testing of production batches against established impurity limits as per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data for health authorities like the US FDA and EMA.

Basic Information

Product Name	Palonosetron Impurity 12
CAS No.	1251515-96-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palonosetron Related Compound 12; Palonosetron Impurity; (3aS)-2-[(1R,5S,6s)-6-Acetyl-8-azabicyclo[3.2.1]oct-8-yl]-2,3,3a,4-tetrahydro-1H-pyrrolo[3,2-c]quinolin-1-one; UNII-6G7J7B2F1F; 6G7J7B2F1F
EINECS	Contact for details

Quality Control

Our Palonosetron Impurity 12 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques such as HPLC, NMR, and MS. We adhere to relevant ICH Q3A/B guidelines for impurities in new drug substances and products.

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 Certificate of Analysis. The material should be kept in a dry environment and handled with appropriate laboratory safety practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with COA
Residual Solvents (GC)	Complies with ICH Q3C

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