Description

Ramosetron Impurity 5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Ramosetron, a potent 5-HT3 receptor antagonist used to prevent nausea and vomiting. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during the development and quality control of Ramosetron API and its formulations.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to ensure accurate impurity detection and quantification.
• Stability Studies and Forced Degradation: Employed in stability-indicating assays to track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Quality Control and Batch Release Testing: Used in routine QC laboratories to establish specification limits and ensure every batch of Ramosetron meets stringent purity requirements.
• Academic and Clinical Research: Supports pharmacological and metabolic studies investigating the properties and behavior of Ramosetron and its related substances.

Basic Information

Product Name	Ramosetron Impurity 5
CAS No.	171967-69-4
Molecular Formula	C₁₇H₂₂N₄O₂
Molecular Weight	314.38 g/mol
Synonyms	(1R,3r,5S)-8-Methyl-8-azabicyclo[3.2.1]oct-3-yl 1-methyl-1H-indazole-3-carboxylate; Ramosetron Related Compound 5; Ramosetron EP Impurity C; Ramosetron USP Impurity; Ramosetron Process Impurity; Ramosetron Degradant; 1H-Indazole-3-carboxylic acid, 1-methyl-, (1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester; Azasetron Impurity (related structure)
EINECS	Contact for details

Quality Control

Every batch of Ramosetron Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH Q3A/B). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, ensuring full traceability and regulatory support for your projects.

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 cool, dry, and well-ventilated area away from incompatible substances. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%
Assay (on dried basis)	98.0% - 102.0%

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