Description

Granisetron Impurity B is a specified impurity and degradation product of the antiemetic drug Granisetron Hydrochloride. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and validation. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Granisetron Hydrochloride active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines on impurities.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and control strategies.
• Research & Synthesis: Serves as an intermediate or marker in the research of Granisetron synthesis pathways and related compounds.

Basic Information

Product Name	Granisetron Impurity B
CAS No.	76272-56-5
Molecular Formula	C18H24N4O
Molecular Weight	312.41 g/mol
Synonyms	1-Methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide; Granisetron Related Compound B; 1-Methyl-1H-indazole-3-carboxylic acid (1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-ylamide; BRL 43694 Impurity B; Kytril Impurity B
EINECS	Contact for details

Quality Control

Our Granisetron Impurity B is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and identity confirmation. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including HPLC purity, NMR, and mass spectrometry for structural confirmation. We support compliance with ICH guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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