Description

Clarithromycin-n-Methyl-13C, D3 is a high-purity, isotopically labeled derivative of the macrolide antibiotic Clarithromycin, specifically labeled with carbon-13 and deuterium. This compound is essential as a certified reference standard and internal standard for precise quantitative analysis in complex matrices. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in method development, pharmacokinetic studies, and bioanalytical research.

Application

• Bioanalytical Method Development: Serves as a critical internal standard for the accurate quantification of Clarithromycin and its metabolites in biological fluids (e.g., plasma, serum) using LC-MS/MS.
• Pharmacokinetic and Metabolism Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Certified Reference Material (CRM): Used for the calibration of analytical instruments and the validation of analytical methods to ensure accuracy and regulatory compliance.
• Stable Isotope Dilution Assays: Provides superior accuracy in mass spectrometry-based assays by correcting for matrix effects and instrument variability.
• Pharmaceutical Quality Control: Supports impurity profiling and assay verification of Clarithromycin active pharmaceutical ingredients (APIs) and finished drug products.
• Forensic and Doping Control Analysis: Acts as a definitive standard for the confirmatory analysis of Clarithromycin in forensic toxicology and anti-doping programs.

Basic Information

Item	Detail
Product Name	Clarithromycin-n-Methyl-13C, D3
CAS No.	959119-22-3
Molecular Formula	C38H6713CD3NO13 *
Molecular Weight	~ 751.00 g/mol *
Synonyms	6-O-Methylerythromycin A-n-Methyl-13C, D3; Clarithromycin (methyl-13C,d3); Clarithromycin-13C,D3; (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-[13C,[2H3]methyl]oxacyclotetradecane-2,10-dione; Isotopically Labeled Clarithromycin
EINECS	Contact for details

* Calculated for the most abundant isotopologue. Contact us for exact specifications.

Quality Control

Our Clarithromycin-n-Methyl-13C, D3 is manufactured under strict quality systems to ensure the highest isotopic and chemical purity required for analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing isotopic enrichment (e.g., 13C, D), chemical purity by HPLC, and identity confirmation by NMR and MS. We adhere to relevant guidelines for reference materials to ensure reliability and traceability in your critical analyses.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C or as specified on the label or Certificate of Analysis. 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 (HPLC-MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment (13C)	≥ 99 atom %
Isotopic Enrichment (D)	≥ 98 atom % (D3)
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits

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