Description

7-Hydroxygranisetron is a key pharmaceutical intermediate and metabolite of the antiemetic drug granisetron. This compound matters significantly for its role in drug metabolism studies, pharmacokinetic research, and the development of analytical reference standards. It is primarily needed by pharmaceutical R&D laboratories, analytical testing facilities, and manufacturers of active pharmaceutical ingredients (APIs) for quality control and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a critical certified reference material (CRM) for the quantitative and qualitative analysis of granisetron and its metabolites in biological matrices.
• Drug Metabolism & Pharmacokinetics (DMPK): Essential for in vitro and in vivo studies to understand the metabolic pathways, clearance, and bioavailability of granisetron.
• Impurity Profiling: Used as a specified impurity standard in the quality control of granisetron API batches to ensure compliance with pharmacopeial limits (e.g., USP, EP).
• Analytical Method Development: A vital component for developing and validating robust HPLC, LC-MS, or GC-MS methods for drug assay and impurity testing.
• Clinical Research: Employed in bioanalytical laboratories to monitor drug and metabolite levels during clinical trials for safety and efficacy.
• Synthetic Intermediate: Can be utilized in the chemical synthesis of granisetron analogs or related serotonergic compounds for new drug discovery.

Basic Information

Product Name	7-Hydroxygranisetron
CAS No.	133841-15-3
Molecular Formula	C18H24N4O
Molecular Weight	312.41 g/mol
Synonyms	1-Methyl-N-(9-methyl-9-azabicyclo[3.3.1]non-3-yl)-1H-indazole-3-carboxamide, 7-hydroxy derivative; Granisetron Metabolite; 1-Methyl-1H-indazole-3-carboxylic acid (1-methyl-9-azabicyclo[3.3.1]non-3-yl)amide, 7-hydroxy-; 7-OH-Granisetron; 7-Hydroxy Granisetron; 7-Hydroxy-1-methyl-N-(9-methyl-9-azabicyclo[3.3.1]non-3-yl)-1H-indazole-3-carboxamide
EINECS	Contact for details

Quality Control

Our 7-Hydroxygranisetron is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical research and development. Certificates of Analysis (COA) detailing purity, related substances, and residual solvents are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment away from direct light exposure to maintain stability and purity.

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 single unknown impurity ≤ 0.5%
Loss on Drying	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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