Description

Tolperisone-D10, Hydrochloride is a deuterated isotopologue of the centrally acting muscle relaxant Tolperisone hydrochloride, where ten hydrogen atoms are replaced by deuterium. This high-purity stable-labeled compound is essential for use as an internal standard in quantitative bioanalytical methods, ensuring unparalleled accuracy and reliability in pharmacokinetic and metabolic studies. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in drug development and regulatory compliance for Tolperisone.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of Tolperisone in complex biological matrices such as plasma, serum, and urine.
• Pharmacokinetic & Metabolism Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Bioanalytical Method Development & Validation: Serves as a reference standard to develop, optimize, and validate robust analytical assays compliant with FDA and ICH guidelines.
• Drug Impurity Profiling & Degradation Studies: Used in stability-indicating methods to identify and quantify potential deuterated impurities or degradation products.
• Forensic & Doping Control Analysis: Supports accurate detection and measurement of Tolperisone in forensic toxicology and anti-doping programs.

Basic Information

Product Name	Tolperisone-D10, Hydrochloride
CAS No.	1185160-65-9
Molecular Formula	C16H13D10ClN2O
Molecular Weight	305.88 g/mol (for deuterated form)
Synonyms	2,4,6-Trimethyl-3-(3,5-dimethylphenyl)-1-piperidinepropanone-D10 Hydrochloride; Tolperisone-d10 HCl; Mydocalm-D10; Mydetone-D10; 2-Methyl-3-piperidino-1-(p-tolyl)-1-propanone-D10 Hydrochloride; 3-(2-Methylpiperidino)-1-(p-tolyl)-1-propanone-D10 Hydrochloride; Peripherally acting muscle relaxant deuterated standard.
EINECS	Contact for details

Quality Control

Every batch of Tolperisone-D10, Hydrochloride is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure it meets the stringent requirements for isotopic purity and chemical purity demanded by modern bioanalysis. Our quality assurance includes comprehensive characterization by NMR, HPLC, and mass spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming specifications for isotopic enrichment, chemical purity, and identity.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant in the container.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (Mass Spectrometry)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Enrichment)	≥ 98.0 atom % D
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.