Description

Nizatidine-D3 is a deuterium-labeled analog of the H₂-receptor antagonist nizatidine, specifically designed for use as an internal standard in quantitative analytical methods. This high-purity stable isotope-labeled compound is essential for ensuring accuracy and reliability in mass spectrometry-based analyses, particularly in pharmacokinetic and metabolic studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in drug development and bioanalytical method validation.

Application

• Internal Standard for LC-MS/MS: Critical for the precise quantification of nizatidine in complex biological matrices such as plasma, serum, and urine.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles.
• Bioanalytical Method Development and Validation: Serves as a reference compound to establish robust, reproducible, and regulatory-compliant analytical assays.
• Clinical Research and Therapeutic Drug Monitoring (TDM): Supports studies measuring drug concentration in patients to optimize dosing regimens.
• Pharmaceutical Impurity Profiling: Aids in the identification and quantification of related substances and degradants in drug substances and products.
• Forensic and Toxicology Analysis: Used in laboratories for the confirmatory analysis of nizatidine in forensic and toxicological casework.

Basic Information

Product Name	Nizatidine-D3
CAS No.	1246833-99-7
Molecular Formula	C12H18D3N5O2S2
Molecular Weight	332.47 g/mol
Synonyms	Nizatidine-d3; [2H3]-Nizatidine; N-[2-[[[2-[(Dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine-d3; 1,1-Ethenediamine, N-[2-[[[2-[(dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N'-methyl-2-nitro-, (Z)-, d3-; Deuteron Nizatidine; Nizatidine (methyl-d3); Stable Isotope Labeled Nizatidine
EINECS	Contact for details

Quality Control

Every batch of Nizatidine-D3 is manufactured and tested under strict quality management systems to ensure the highest standards of isotopic purity and chemical integrity. Our products undergo rigorous analytical characterization, including NMR, HPLC, and mass spectrometry, to confirm identity, chemical purity, and isotopic enrichment. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality documentation requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (MS)	≥ 99.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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