Description

Metaxalone Usp Rc C is a high-purity pharmaceutical reference standard and active pharmaceutical ingredient (API) used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of muscle relaxant formulations during development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories engaged in quality control, method validation, and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Used as a primary standard for the identification, assay, and impurity profiling of Metaxalone in drug products and raw materials.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, GC, and spectroscopic methods for quality control laboratories.
• Pharmacological Research: Employed in preclinical and clinical studies to investigate the pharmacokinetics, metabolism, and mechanism of action of skeletal muscle relaxants.
• Quality Control & Assurance: Essential for routine testing and batch release in API and finished dosage form manufacturing to ensure compliance with specified monographs.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing authenticated material for stability studies and specification setting.

Basic Information

Product Name	Metaxalone Usp Rc C
CAS No.	805972-34-3
Molecular Formula	C12H15NO3
Molecular Weight	221.25 g/mol
Synonyms	Metaxalone; 5-[(3,5-Dimethylphenoxy)methyl]-2-oxazolidinone; 2-Oxazolidinone, 5-[(3,5-dimethylphenoxy)methyl]-; Skelaxin (brand name); Metaxalon; NSC 102627; AHR-438
EINECS	Contact for details

Quality Control

Our Metaxalone Usp Rc C is manufactured and tested to meet stringent pharmacopeial standards. Each batch undergoes comprehensive analytical testing, including identification, assay, and impurity profiling, to ensure compliance with relevant USP (United States Pharmacopeia) monograph requirements. A detailed Certificate of Analysis (COA) is provided, confirming identity, purity, and conformance to specifications.

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 must be kept in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%

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