Description

Cyclosporine Metabolite M21 is a key pharmacologically active metabolite of the immunosuppressant drug Cyclosporine A. This compound is of critical importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and therapeutic drug monitoring. It serves as an essential reference standard for analytical laboratories in pharmaceutical, clinical, and academic settings. The CAS number for this compound is 89270-23-5.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Cyclosporine and its metabolites in biological matrices.
• Drug Metabolism & Pharmacokinetics (DMPK) Studies: Crucial for in vitro and in vivo studies to understand the metabolic pathways, clearance, and bioavailability of Cyclosporine-based therapies.
• Therapeutic Drug Monitoring (TDM): Used to calibrate assays (e.g., HPLC, LC-MS/MS) for accurately measuring metabolite levels in patient blood samples to optimize dosing and minimize toxicity.
• Bioanalytical Method Development & Validation: Serves as a critical component in developing, validating, and ensuring the regulatory compliance of analytical methods for immunosuppressant drugs.
• Clinical Research: Supports investigations into the correlation between metabolite concentrations and clinical outcomes (efficacy and adverse events) in transplant and autoimmune disease patients.
• Impurity Profiling: Used in the quality control of Cyclosporine Active Pharmaceutical Ingredients (APIs) and finished drug products to identify and quantify related substances.

Basic Information

Product Name	Cyclosporine Metabolite M21
CAS No.	89270-23-5
Molecular Formula	C62H111N11O12
Molecular Weight	1202.6 g/mol
Synonyms	Cyclosporin M21; AM1; Cyclosporine Metabolite AM1; Cyclosporine Metabolite 1; (3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-30-Ethyl-33-[(1R,2R,4E)-1-hydroxy-2-methyl-4-hexen-1-yl]-6,9,18,24-tetraisobutyl-3,21-diisopropyl-1,4,7,10,12,15,19,25,28-nonamethyl-1,4,7,10,13,16,19,22,25,28,31-undecaazacyclotetratriacontane-2,5,8,11,14,17,20,23,26,29,32-undecone
EINECS	Contact for details

Quality Control

Our Cyclosporine Metabolite M21 is manufactured under strict quality control protocols suitable for analytical and research applications. Each batch undergoes comprehensive testing including identity confirmation by spectroscopic methods (NMR, IR, MS), purity assessment by HPLC, and determination of related substances. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring traceability, consistency, and compliance with in-house specifications developed for reference standard use.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). For long-term stability, storage at -20°C is recommended. The container should be kept in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%

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