Description

9-Hydroxy-9-Desmethylcyclosporine is a key metabolite and structural analog of the potent immunosuppressant Cyclosporine A. This compound is of significant interest for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and the development of novel immunosuppressive agents with potentially improved therapeutic profiles. It serves as a critical reference standard and intermediate for researchers and manufacturers in the pharmaceutical, biotechnology, and fine chemical synthesis sectors.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for analytical method development, validation, and quality control in drug testing laboratories.
• Metabolite Research: Essential for studying the metabolic pathways, bioavailability, and clearance mechanisms of Cyclosporine A in preclinical and clinical research.
• Active Pharmaceutical Ingredient (API) Intermediate: Serves as a sophisticated building block in the synthetic pathways for novel immunosuppressant candidates.
• Biochemical Research: Employed in studies investigating the structure-activity relationships (SAR) of cyclosporine derivatives and their interaction with cellular targets like cyclophilin.
• Impurity Profiling: Used to identify, quantify, and control related substance impurities in Cyclosporine A bulk drug and finished dosage forms.

Basic Information

Product Name	9-Hydroxy-9-Desmethylcyclosporine
CAS No.	132362-39-1
Molecular Formula	C61H111N11O13
Molecular Weight	1206.61 g/mol
Synonyms	9-Hydroxy-9-Desmethyl-Cyclosporin A; Cyclosporin A, 9-hydroxy-9-desmethyl-; 9-Hydroxy-9-Desmethyl-CsA; 9-OH-9-Desmethyl Cyclosporine; AM1 Metabolite of Cyclosporine; (3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-30-Ethyl-33-[(1R,2R,4E)-1-hydroxy-2-methyl-4-hexen-1-yl]-1,4,7,10,12,15,19,25,28-nonamethyl-6,9,18,24-tetrakis(2-methylpropyl)-3,21-di(propan-2-yl)-1,4,7,10,13,16,19,22,25,28,31-undecaazatricyclo[30.3.0.012,16]pentatriacontane-2,5,8,11,14,17,20,23,26,29,32-undecone
EINECS	Contact for details

Quality Control

Our 9-Hydroxy-9-Desmethylcyclosporine is produced and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the exacting standards required for pharmaceutical research. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting critical parameters such as assay, related substances, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. For long-term storage, consider desiccation.

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)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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