Description

Granisetron Impurity F is a designated impurity standard used in the analytical profiling and quality control of the antiemetic pharmaceutical, Granisetron. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) and its finished dosage forms. It is an essential component for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) involved in method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Granisetron Impurity F in Granisetron API and drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine QC testing to monitor impurity levels and ensure batches meet pharmacopeial (e.g., USP, EP) or internal specifications.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop purification processes for the API.

Basic Information

Product Name	Granisetron Impurity F
CAS No.	1364914-39-5
Molecular Formula	C18H24N4O
Molecular Weight	312.41 g/mol
Synonyms	1-Methyl-N-((1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]nonan-3-yl)-1H-indazole-3-carboxamide; Granisetron Related Compound F; Granisetron EP Impurity F; Granisetron USP Impurity F; 1H-Indazole-3-carboxamide, 1-methyl-N-((1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl)-; UNII-9K2V7138QJ
EINECS	Contact for details

Quality Control

Every batch of Granisetron Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatographic purity and assigned chemical structure, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C. The material should be handled in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Assay (HPLC)	90.0% - 110.0% on anhydrous basis
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.