Description

[2H3]-Granisetron is a stable isotope-labeled analog of the potent and selective 5-HT3 receptor antagonist, Granisetron. This deuterated compound is an essential internal standard for the accurate quantification of Granisetron in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in pharmacokinetic studies, bioequivalence testing, and drug metabolism research.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard for the precise and accurate measurement of Granisetron concentrations in plasma, serum, and other biological fluids via mass spectrometry.
• Pharmacokinetic (PK) Studies: Enables reliable tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in clinical and non-clinical research.
• Drug Metabolism and Disposition (DMPK): Used in metabolite identification and profiling studies to understand the biotransformation pathways of Granisetron.
• Bioequivalence Testing: Supports regulatory submissions for generic drug development by ensuring accurate comparison of test and reference formulations.
• Forensic and Clinical Toxicology: Aids in the specific and sensitive detection of Granisetron in forensic analyses or therapeutic drug monitoring.
• Method Development and Validation: Essential for developing, optimizing, and validating robust LC-MS/MS analytical methods in compliance with GLP and ICH guidelines.

Basic Information

Product Name	[2H3]-Granisetron
CAS No.	1224925-64-7
Molecular Formula	C18H21D3N4O
Molecular Weight	315.41 g/mol
Synonyms	Granisetron-d3; Deuterated Granisetron; 1-Methyl-N-((1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl)-1H-indazole-3-carboxamide-d3; 1H-Indazole-3-carboxamide, 1-methyl-N-((1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl)-, d3-; Kytril-d3; Sancuso-d3; Stable Isotope-Labeled Granisetron
EINECS	Contact for details

Quality Control

Every batch of [2H3]-Granisetron is manufactured under controlled conditions and undergoes comprehensive analytical testing to ensure the highest standards of chemical purity, isotopic enrichment, and structural identity. Our quality protocols are designed to meet the stringent requirements of analytical reference standard applications. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming specifications for assay, isotopic purity, and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (MS)	≥99.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH limits

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