Description

Metformin-D6, Hydrochloride is a stable isotope-labeled analog of the widely used antidiabetic drug, Metformin, where six hydrogen atoms are replaced by deuterium. This high-purity 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 a critical tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in drug development and clinical research for diabetes and metabolic disorders.

Application

• Internal Standard for LC-MS/MS: Primary application as a deuterated internal standard in Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) for the precise quantification of Metformin in biological matrices (plasma, serum, urine).
• Drug Metabolism and Pharmacokinetics (DMPK): Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical studies.
• Clinical Research & Bioequivalence Studies: Critical for ensuring data integrity in clinical trials and bioequivalence testing of generic Metformin formulations.
• Forensic and Doping Analysis: Used in specialized laboratories for the confirmatory analysis of Metformin in forensic toxicology and anti-doping controls.
• Stable Isotope Dilution Assays: Serves as the labeled component in high-accuracy assays to minimize matrix effects and ionization variability.
• Method Development and Validation: A key reagent for developing, optimizing, and validating robust analytical methods in compliance with FDA, EMA, and ICH guidelines.

Basic Information

Product Name	Metformin-D6, Hydrochloride
CAS No.	1185166-01-1
Molecular Formula	C4H5D6ClN5
Molecular Weight	171.66 g/mol
Synonyms	1,1-Dimethylbiguanide-D6 hydrochloride; Metformin-d6 HCl; N,N-Dimethylimidodicarbonimidic diamide-d6 hydrochloride; Dimethylbiguanide-D6 hydrochloride; Glucophage-d6 (labeled analog); (Diaminomethylideneamino)(dimethyl-d6)carbamimidoylazanium chloride
EINECS	Contact for details

Quality Control

Every batch of Metformin-D6, Hydrochloride is manufactured and tested under strict quality systems. We guarantee high chemical and isotopic purity, with comprehensive testing including assay, isotopic enrichment (D-content), and impurity profiling. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specifications for use in regulated bioanalysis. Our quality commitment supports your adherence to GMP, GLPs, and ICH Q2(R1) guidelines for analytical method validation.

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). For long-term storage, keep the container in a dry environment. Handle with standard laboratory precautions.

Specification

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