Description

Cyclosporine Metabolite M17 CAS NO 89270-28-0 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 is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in bioequivalence studies, metabolite profiling, and the development of sensitive analytical methods.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of Cyclosporine and its metabolites in biological matrices.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for investigating the metabolic pathways, clearance, and exposure levels of Cyclosporine in preclinical and clinical research.
• Therapeutic Drug Monitoring (TDM) Assay Development: Used to calibrate and validate immunoassays, LC-MS/MS, and HPLC methods for accurate measurement of drug levels in patient blood samples.
• Bioequivalence and Biosimilar Studies: Critical for comparing the metabolite profiles of generic or biosimilar Cyclosporine formulations against the innovator product.
• Impurity Profiling: Employed as an impurity standard in the quality control of Cyclosporine Active Pharmaceutical Ingredient (API) to ensure product purity and safety.
• Academic and Clinical Research: Supports fundamental research into immunosuppression mechanisms and personalized medicine approaches for transplant patients.

Basic Information

Product Name	Cyclosporine Metabolite M17
CAS No.	89270-28-0
Molecular Formula	C62H111N11O12
Molecular Weight	1202.6 g/mol
Synonyms	Cyclosporin M17; AM1; Cyclosporine Metabolite AM1; Cyclosporine Metabolite 17; (3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-30-Ethyl-33-[(1R,2R,6S)-1-hydroxy-2-methyl-6-(1E)-1-methylprop-1-en-1-yl]-3,6,21,24-tetraisobutyl-9-(2-methylpropyl-1-oxide)-1,4,7,10,12,15,19,25,28-nonamethyl-1,4,7,10,13,16,19,22,25,28,31-undecaazatricyclo[30.3.0.015,19]pentatriacontane-2,5,8,11,14,17,20,23,26,29,32-undecone
EINECS	Contact for details

Quality Control

Our Cyclosporine Metabolite M17 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (NMR, MS), to ensure it meets the stringent requirements for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. We support compliance with cGMP, ICH Q7, and ISO 17034 guidelines for reference material producers.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. This product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a desiccator before opening to prevent condensation and moisture uptake.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Specific Optical Rotation	Contact for details

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