Description

Trimetazidine-D8 Dihydrochloride is a high-purity, stable isotope-labeled analog of the anti-ischemic agent Trimetazidine, specifically designed for use as an internal standard in quantitative analytical methods. This deuterated compound is essential for ensuring accuracy and reliability in pharmacokinetic, metabolic, and bioanalytical studies, where precise measurement is critical. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in drug development and regulatory compliance work.

Application

• Internal Standard for LC-MS/MS: Primary application as a quantitative internal standard in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) bioanalysis of Trimetazidine and its metabolites.
• Pharmacokinetic & Metabolism Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Biomarker Analysis: Used in method development and validation for the precise quantification of Trimetazidine in complex biological matrices like plasma, serum, and urine.
• Drug Impurity Profiling: Assists in the identification and quantification of related substances and degradation products during drug substance and product stability testing.
• Forensic & Doping Control Analysis: Supports high-confidence confirmatory testing in forensic toxicology and anti-doping programs.
• Reference Material for GLP/GMP Compliance: Serves as a certified reference material in laboratories operating under Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP) guidelines.

Basic Information

Product Name	Trimetazidine-D8 Dihydrochloride
CAS No.	1219795-37-5
Molecular Formula	C14H11D8N2O3·2HCl
Molecular Weight	359.31 g/mol (approx.)
Synonyms	1-[(2,3,4-Trimethoxyphenyl)methyl]piperazine-2,2,3,3,5,5,6,6-d8 Dihydrochloride; Trimetazidine-d8; Deuterated Trimetazidine Dihydrochloride; Trimetazidine (phenyl-d8) Dihydrochloride; TMZ-D8; Vastarel-d8 (labeled analog); 2,2,3,3,5,5,6,6-Octadeutero-1-[(2,3,4-trimethoxyphenyl)methyl]piperazine Dihydrochloride
EINECS	Contact for details

Quality Control

Every batch of Trimetazidine-D8 Dihydrochloride is manufactured and tested under strict quality systems to ensure the highest standards of isotopic purity and chemical integrity. Our quality control protocols include comprehensive analysis by NMR (¹H, ¹³C), HPLC, and mass spectrometry to confirm isotopic enrichment (typically ≥98% D), chemical purity (≥95%), and identity. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting all critical parameters to support your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95%
Isotopic Purity (Deuterium Content)	≥ 98 atom % D
Chemical Purity (by NMR)	Conforms
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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