Description

Azithromycin-D3 is a deuterium-labeled analog of the broad-spectrum macrolide antibiotic azithromycin, specifically designed for use as an internal standard in analytical chemistry. This high-purity stable isotope-labeled compound is essential for ensuring the accuracy and reliability of quantitative mass spectrometry analyses. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities engaged in pharmacokinetic studies, drug metabolism research, and bioanalytical method development.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard in LC-MS/MS and GC-MS methods for the precise quantification of azithromycin in biological matrices such as plasma, serum, and tissue homogenates.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and non-clinical studies.
• Drug Metabolism Research: Used in metabolite identification and profiling studies to differentiate between drug-derived and endogenous compounds.
• Method Development and Validation: A key component in developing and validating robust, regulatory-compliant analytical methods for Good Laboratory Practice (GLP) and clinical trials.
• Quality Control in Manufacturing: Can be employed in impurity profiling and assay verification during the production of azithromycin active pharmaceutical ingredients (APIs).
• Forensic and Anti-Doping Analysis: Supports accurate measurement in forensic toxicology and sports anti-doping control programs.

Basic Information

Item	Detail
Product Name	Azithromycin-D3
CAS No.	163921-65-1
Molecular Formula	C38H69D3N2O12
Molecular Weight	749.00 g/mol (approx.)
Synonyms	9-Deoxo-9a-aza-9a-methyl-9a-homoerythromycin A-D3; Azithromycin (methyl-D3); 9-Deoxo-9a-methyl-9a-aza-9a-homoerythromycin A-D3; Azithromycin-d3; Deuterated Azithromycin; Azithromycin Internal Standard; (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-Ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-15-oxo-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadec-13-yl 2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranoside-D3
EINECS	Contact for details

Quality Control

Our Azithromycin-D3 is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is characterized by advanced spectroscopic and chromatographic techniques, including NMR, HPLC, and mass spectrometry, to confirm identity, isotopic enrichment (typically ≥98 atom % D), and chemical purity (typically ≥95%). A comprehensive Certificate of Analysis (COA) detailing all specifications is provided with every shipment.

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 should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Isotopic Purity	≥ 98 atom % D
Chemical Purity	≥ 95.0%
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.