Description

n-Desmethyl Nefopam HCl is a key pharmaceutical intermediate and analytical reference standard, primarily used in the research, development, and quality control of the analgesic drug nefopam. This compound is critical for ensuring the purity, safety, and efficacy of the final pharmaceutical product. It is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug synthesis, impurity profiling, and metabolic studies.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of the analgesic drug Nefopam Hydrochloride.
• Analytical Reference Standard: Used in HPLC, LC-MS, and other chromatographic methods for the identification and quantification of impurities in Nefopam API and finished dosage forms.
• Metabolite Studies: Serves as a reference compound for pharmacokinetic and metabolic pathway research related to Nefopam.
• Quality Control & Assurance: Essential for pharmaceutical QC labs to establish specifications and validate analytical methods for drug substance and product release.
• Research & Development: Used in medicinal chemistry programs for the development of new analogs or formulations based on the Nefopam structure.
• Regulatory Compliance: Supports regulatory filings (e.g., with FDA, EMA) by providing a characterized impurity standard for stability and batch testing.

Basic Information

Product Name	n-Desmethyl Nefopam HCl
CAS No.	147656-98-2
Molecular Formula	C16H17NO•HCl
Molecular Weight	275.77 g/mol
Synonyms	Desmethylnefopam Hydrochloride; 5-Methyl-1-phenyl-3,4,5,6-tetrahydro-1H-2,5-benzoxazocine Hydrochloride; N-Desmethyl Nefopam Hydrochloride; Nefopam Impurity C (HCl); Nefopam Metabolite; 1-Phenyl-5-methyl-3,4,5,6-tetrahydro-1H-2,5-benzoxazocine Hydrochloride; Nefopam Related Compound C
EINECS	Contact for details

Quality Control

Our n-Desmethyl Nefopam HCl is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification, assay, and impurity profile determination via validated methods such as HPLC and NMR. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with ICH guidelines and current Good Manufacturing Practice (cGMP) principles for pharmaceutical intermediates.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture.

Specification

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

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