Description

Nabumetone Related Compound A (15 Mg) (1-(6-Methoxy-2-Naphthyl)-But-1-En-3-One) is a high-purity reference standard critical for pharmaceutical research and quality control. This compound serves as a key impurity marker and analytical standard for ensuring the purity and safety of the active pharmaceutical ingredient (API) Nabumetone. It is essential for laboratories in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors engaged in method development, validation, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material (CRM) for the identification and quantification of related substances in Nabumetone API and finished dosage forms according to ICH Q3A/B guidelines.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and GC methods for stability-indicating assays.
• Pharmacopoeial Compliance: Supports testing to meet the stringent specifications of USP (United States Pharmacopeia), EP (European Pharmacopoeia), and other international pharmacopoeias.
• Stability Studies: Employed as a benchmark in forced degradation and long-term stability studies to monitor impurity formation in drug products.
• Quality Assurance/Quality Control (QA/QC): Provides a reliable standard for routine batch release testing in pharmaceutical manufacturing to ensure product consistency and safety.
• Regulatory Submissions: Essential for generating impurity data required for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.

Basic Information

Product Name	Nabumetone Related Compound A (15 Mg) (1-(6-Methoxy-2-Naphthyl)-But-1-En-3-One)
CAS No.	127053-22-9
Molecular Formula	C15H16O2
Molecular Weight	228.29 g/mol
Synonyms	1-(6-Methoxy-2-naphthyl)-1-buten-3-one; 1-(6-Methoxy-2-naphthyl)but-1-en-3-one; Nabumetone Impurity A; Nabumetone Related Substance A; Nabumetone EP Impurity A; Nabumetone USP Related Compound A; (E)-1-(6-Methoxynaphthalen-2-yl)but-1-en-3-one
EINECS	Contact for details

Quality Control

This reference standard is manufactured and controlled under a strict quality management system. Each batch is characterized using advanced analytical techniques including NMR, MS, and HPLC to confirm identity and purity. A comprehensive Certificate of Analysis (CoA) is provided, detailing the results for assay, related substances, and other critical parameters. Our quality protocols are designed to support compliance with cGMP, ICH, and relevant pharmacopoeial (USP/EP) standards for pharmaceutical impurities.

Storage

Preserve in the original tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a low-humidity 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 standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.