Description

Ondansetron Hcl Impurity-G CAS NO 99614-03-6 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the antiemetic drug Ondansetron Hydrochloride by accurately identifying and quantifying process-related impurities. It is an essential material for analytical chemists, quality assurance professionals, and research scientists working in pharmaceutical R&D, quality control laboratories, and regulatory affairs.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Ondansetron Hcl Impurity-G in drug substances and finished products.
• Method Development and Validation: Used in developing and validating analytical methods, such as HPLC, UPLC, and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring drug product consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity specifications and justify safety thresholds.
• Stability Studies: Used as a marker to track impurity formation and degradation pathways in drug stability testing programs.
• Research and Development: Facilitates process chemistry research to understand and minimize the formation of this impurity during synthesis.

Basic Information

Product Name	Ondansetron Hcl Impurity-G
CAS No.	99614-03-6
Molecular Formula	C18H19N3O
Molecular Weight	293.37 g/mol
Synonyms	1,2,3,9-Tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one; Ondansetron Impurity G; Ondansetron Related Compound G; GR 38032F Impurity; Zofran Impurity G; 4H-Carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-
EINECS	Contact for details

Quality Control

Every batch of Ondansetron Hcl Impurity-G is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure compliance with high-grade reference standard specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle with appropriate laboratory safety practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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