Description

Exo-Granisetron (Granisetron Impurity F) is a specified impurity of the antiemetic pharmaceutical agent Granisetron, used in quality control and analytical research. This compound is critical for ensuring the purity, safety, and efficacy of Granisetron drug substances and finished products by serving as a reference standard. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Granisetron Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurities in Granisetron batches.
• Quality Control & Assurance: Employed in routine QC testing to ensure Granisetron meets pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B) for impurity profiles.
• Stability Studies: Used to track the formation and levels of this specific degradation product during forced degradation and long-term stability studies of Granisetron formulations.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Supports synthetic chemistry research aimed at understanding the degradation pathways of Granisetron and improving synthetic processes to minimize impurity formation.

Basic Information

Product Name	Exo-Granisetron (Granisetron Impurity F)
CAS No.	127472-42-8
Molecular Formula	C18H24N4O
Molecular Weight	312.41 g/mol
Synonyms	Granisetron Impurity F; 1-Methyl-N-((1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]nonan-3-yl)-1H-indazole-3-carboxamide; (1R,3r,5S)-3-((1-Methyl-1H-indazol-3-yl)carbonylamino)-9-methyl-9-azabicyclo[3.3.1]nonane; Exo-isomer of Granisetron; Granisetron Related Compound F
EINECS	Contact for details

Quality Control

Our Exo-Granisetron (Granisetron Impurity F) is manufactured under strict quality systems suitable for use as a pharmaceutical reference standard. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for regulatory and research applications. A comprehensive Certificate of Analysis (COA) detailing purity, chromatographic data, and storage recommendations is 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 should be handled in a dry environment to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.