Description

Ondansetron Impurity B is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the antiemetic drug Ondansetron during its development and manufacturing. It is primarily required by pharmaceutical companies, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and batch release testing. The availability of a well-characterized impurity standard is essential for compliance with stringent global pharmacopeial guidelines.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material to identify, quantify, and monitor this specific impurity in Ondansetron Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Ondansetron.
• Quality Control & Batch Release: Employed as a system suitability standard and for comparative analysis in the routine QC testing of Ondansetron to ensure it meets ICH, USP, or EP specifications.
• Regulatory Compliance and Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and demonstrate control strategies for the drug substance.
• Stability Studies: Used to track the formation and level of this impurity under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Research and Development: Facilitates chemical and pharmacological research to understand the formation pathway and potential impact of this impurity.

Basic Information

Product Name	Ondansetron Impurity B
CAS No.	1076198-52-1
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 Related Compound B; (RS)-9-Methyl-3-[(2-methylimidazol-1-yl)methyl]-1,2,3,9-tetrahydro-4H-carbazol-4-one; Zofran Impurity B; GR 38032 Impurity
EINECS	Contact for details

Quality Control

Every batch of Ondansetron Impurity B is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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