Description

Ramosetron Impurity 13 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 antiemetic drug Ramosetron hydrochloride during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments. The precise characterization of this impurity is essential for method validation, stability studies, and meeting stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Ramosetron Impurity 13 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling of Ramosetron.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with specifications.
• Stability Studies: A key component in forced degradation and long-term stability studies to understand the degradation pathways of Ramosetron.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the fate of this impurity in biological systems.

Basic Information

Item	Details
Product Name	Ramosetron Impurity 13
CAS No.	183613-77-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ramosetron Related Compound 13; Ramosetron EP Impurity C; Ramosetron Hydrochloride Impurity 13; (1R,3r,5S)-8-Methyl-8-azabicyclo[3.2.1]oct-3-yl 1-methyl-1H-indazole-3-carboxylate; Granisetron Impurity; 1H-Indazole-3-carboxylic acid, 1-methyl-, (1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl ester; Ramosetron Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Ramosetron Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and mass spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. Desiccants are recommended for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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