Description

Nabumetone Dimer Impurity is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity and safety of the active pharmaceutical ingredient (API) nabumetone by enabling accurate identification and quantification of its dimeric byproduct. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory bodies focused on method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the analysis of nabumetone API.
• Method Development & Validation: Critical for developing and validating HPLC, UPLC, and other chromatographic methods in QC laboratories.
• Stability Studies: Used to monitor the formation of degradation products in nabumetone formulations under various storage conditions.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing impurity characterization data for drug master files.
• Pharmaceutical Research: Serves as a key intermediate or impurity marker in synthetic chemistry and process optimization research for nabumetone.
• Quality Control Testing: Enables precise assay and impurity profiling to ensure nabumetone batches meet pharmacopeial specifications (USP, EP).

Basic Information

Product Name	Nabumetone Dimer Impurity
CAS No.	343272-53-7
Molecular Formula	C30H34O4
Molecular Weight	458.59 g/mol
Synonyms	Nabumetone Dimer; Nabumetone Related Compound D; 4-(6-Methoxy-2-naphthalenyl)-2-butanone Dimer; 1,3-Bis[4-(6-methoxy-2-naphthyl)-2-oxobutyl]benzene; Bufexamac Impurity D (related); Nabumetone Impurity D
EINECS	Contact for details

Quality Control

Every batch of Nabumetone Dimer Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with industry and client specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single impurity ≤ 2.0%; Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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