Description

Palonosetron Impurity Tm1-Rr 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 essential for method development, validation, and routine testing in the production of Palonosetron hydrochloride active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Tm1-Rr in Palonosetron API and drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate stability-indicating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: A critical component in the QC laboratory for routine impurity testing to ensure batches meet ICH guidelines and regulatory specifications.
• Stability Studies: Employed to monitor the formation and level of this specific impurity during forced degradation and long-term stability studies of Palonosetron formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation during the manufacturing process.

Basic Information

Product Name	Palonosetron Impurity Tm1-Rr
CAS No.	1022895-91-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Palonosetron Related Compound Tm1-Rr; Palonosetron Impurity R; (3aS)-2-[(3S)-1-Azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4-tetrahydro-1H-benz[de]isoquinolin-1-one; Palonosetron Process Impurity; Aloxi Impurity Tm1-Rr
EINECS	Contact for details

Quality Control

Our Palonosetron Impurity Tm1-Rr is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and analytical results.

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. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.