Description

Ondansetron Ep Impurity H CAS NO 201409-17-8 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the antiemetic drug Ondansetron. This compound is critical for pharmaceutical research and development, enabling precise analytical method validation and ensuring drug safety and efficacy. It is an essential material for quality control laboratories in the pharmaceutical industry, regulatory bodies, and contract research organizations (CROs) focused on impurity profiling and compliance with ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ondansetron Ep Impurity H in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component for developing, optimizing, and validating chromatographic methods to monitor and control impurity levels.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical manufacturing to ensure product purity and compliance with pharmacopeial specifications (e.g., USP, EP).
• Regulatory Submissions & Compliance: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability testing of Ondansetron formulations.
• Research on Degradation Pathways: Aids in studying the chemical stability and degradation mechanisms of Ondansetron under various conditions.

Basic Information

Product Name	Ondansetron Ep Impurity H
CAS No.	201409-17-8
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 H; Ondansetron Related Compound H; GR 38032F Impurity H; Ep Impurity H of Ondansetron; Zofran Impurity H
EINECS	Contact for details

Quality Control

Our Ondansetron Ep Impurity H is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. We support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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