Description

Nefopam-D3 Hcl CAS NO 1346603-30-2 is a deuterium-labeled analog of the centrally-acting, non-opioid analgesic Nefopam hydrochloride, serving as a critical internal standard for precise analytical quantification. This high-purity reference material is essential for ensuring accuracy and reliability in pharmacokinetic and metabolic studies, where distinguishing the parent compound from its metabolites is paramount. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in method development, bioanalysis, and quality control for analgesic drug formulations.

Application

• Internal Standard for LC-MS/MS Analysis: Used as a deuterated internal standard in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for the accurate quantification of Nefopam in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic and Bioavailability Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and pre-clinical research.
• Metabolite Profiling and Identification: Facilitates the differentiation between the administered drug and its metabolites during metabolic pathway studies.
• Method Development and Validation: Critical for developing and validating robust, sensitive, and specific analytical methods in compliance with ICH and FDA guidelines.
• Quality Control in Pharmaceutical Manufacturing: Supports impurity profiling and assay verification of Nefopam active pharmaceutical ingredient (API) and finished dosage forms.
• Forensic and Toxicology Analysis: Employed in forensic laboratories for the definitive identification and quantification of Nefopam in relevant cases.

Basic Information

Product Name	Nefopam-D3 Hcl
CAS No.	1346603-30-2
Molecular Formula	C17H16D3NO•HCl
Molecular Weight	289.82 g/mol
Synonyms	Nefopam-d3 Hydrochloride; 5-Methyl-1-phenyl-3,4,5,6-tetrahydro-1H-2,5-benzoxazocine-d3 Hydrochloride; Fenazoxine-d3 HCl; Acupan-d3 (deuterated); Benzoxazocine-d3 derivative; [2H3]-Nefopam HCl; Nefopam (phenyl-d3) Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Nefopam-D3 Hcl is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data including NMR (1H, 13C), Mass Spectrometry, and HPLC. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, isotopic enrichment, and confirming the absence of unlabeled compound. Our quality commitment ensures the material meets the stringent requirements for use in regulated bioanalytical method development and validation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (MS)	≥98.0 atom % D
Chemical Purity (NMR)	Conforms
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.