Description

Granisetron Impurity 7 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antiemetic drug Granisetron. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of a well-characterized impurity standard is essential for maintaining the stringent purity profiles mandated in modern pharmacopeias.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Granisetron Impurity 7 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in accordance with ICH guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to monitor impurity levels and ensure drug substance and product specifications meet USP, EP, or other pharmacopeial standards.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate comprehensive impurity profiling.
• Research & Development: Serves as a key material in synthetic chemistry R&D for process optimization and impurity fate and tolerance studies.

Basic Information

Product Name	Granisetron Impurity 7 Hcl
CAS No.	110766-33-1
Molecular Formula	C18H25ClN4O2 • HCl
Molecular Weight	409.33 g/mol (for free base: 372.87 g/mol)
Synonyms	Granisetron Related Compound H; 1-Methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide Hydrochloride; Granisetron EP Impurity H; Granisetron USP Impurity H; 1-Methyl-1H-indazole-3-carboxylic acid (1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-ylamide hydrochloride; BRL-43694 Impurity 7 HCl
EINECS	Contact for details

Quality Control

Every batch of Granisetron Impurity 7 Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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