Description

n-Desmethyl Clarithromycin is a key pharmaceutical intermediate and metabolite of the macrolide antibiotic clarithromycin. This compound is of significant importance for research and development in the pharmaceutical industry, particularly in the study of drug metabolism, pharmacokinetics, and the synthesis of novel antibiotic derivatives. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in advanced antibiotic development and analytical method validation.

Application

• Pharmaceutical Intermediate: Critical starting material or precursor in the synthesis of advanced clarithromycin derivatives and novel macrolide antibiotics.
• Metabolite Reference Standard: Used as an analytical standard in bioanalytical studies to identify and quantify the metabolite in biological matrices for pharmacokinetic and toxicokinetic assessments.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Essential for studying the metabolic pathways, bioavailability, and clearance mechanisms of clarithromycin.
• Impurity Profiling: Serves as a known impurity standard in the quality control of clarithromycin active pharmaceutical ingredient (API) to ensure product purity and compliance with pharmacopeial standards (e.g., USP, EP).
• Clinical Research: Employed in studies investigating patient variability in drug metabolism and the clinical significance of specific metabolic pathways.
• Analytical Method Development: Used to develop and validate sensitive HPLC, LC-MS, or GC-MS methods for the detection of clarithromycin and its metabolites.

Basic Information

Product Name	n-Desmethyl Clarithromycin
CAS No.	101666-68-6
Molecular Formula	C37H66NO12
Molecular Weight	716.92 g/mol
Synonyms	6-O-Methylerythromycin D; Clarithromycin Impurity D; Clarithromycin Metabolite; 14-Hydroxy-6-O-methylerythromycin D; (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione
EINECS	Contact for details

Quality Control

Our n-Desmethyl Clarithromycin is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification, assay, and impurity profiling via HPLC, to ensure it meets high-purity standards suitable for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic data are provided to support regulatory submissions and internal quality assurance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.2%

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