Description

Granisetron Impurity C is a specified impurity of the antiemetic drug Granisetron Hydrochloride, used to monitor and control the quality of the active pharmaceutical ingredient (API). This high-purity reference standard is critical for ensuring drug safety, efficacy, and regulatory compliance during development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) involved in analytical method development, validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Granisetron HCl API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling and forced degradation studies.
• Quality Control & Batch Release Testing: Essential for routine QC testing to ensure impurity levels in commercial API batches comply with pharmacopeial limits (e.g., ICH Q3A/B).
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Process Chemistry Research: Helps chemists identify and eliminate the source of this impurity during API synthesis and purification process optimization.

Basic Information

Product Name	Granisetron Impurity C
CAS No.	160177-67-3
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 C; 1-Methyl-1H-indazole-3-carboxylic acid (1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-ylamide; Granisetron Impurity 3; UNII-6J4A3W6V0H
EINECS	Contact for details

Quality Control

Every batch of Granisetron Impurity C is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including advanced chromatographic techniques, to ensure high chemical purity and accurate identification, aligning with current pharmacopeial expectations for reference standards. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profile is provided with each shipment to support your regulatory and quality requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.