Description

Cyclosporine Resolution Mixture (25 Mg) is a critical analytical standard used for the separation and identification of Cyclosporine A and its related compounds. This high-purity mixture is essential for ensuring the accuracy and reliability of chromatographic methods in pharmaceutical quality control. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical manufacturers involved in the development, production, and regulatory compliance of immunosuppressant drugs.

Application

• Primary standard for the HPLC and UPLC method development and validation of Cyclosporine A.
• System suitability testing for chromatographic assays in pharmaceutical quality control laboratories.
• Reference material for the identification and resolution of Cyclosporine isomers and impurities in active pharmaceutical ingredient (API) analysis.
• Calibration standard for ensuring the precision of analytical instruments in pharmacopoeial testing (e.g., USP, EP monographs).
• Critical tool in bioanalytical research for studying drug metabolism and pharmacokinetics.
• Supporting material for regulatory submissions to agencies like the FDA and EMA, requiring validated analytical methods.

Basic Information

Product Name	Cyclosporine Resolution Mixture (25 Mg)
CAS No.	108027-45-8
Molecular Formula	C62H111N11O12
Molecular Weight	1202.61 g/mol
Synonyms	Cyclosporin Resolution Mixture; Cyclosporine A Resolution Mixture; CsA Resolution Mixture; Ciclosporin Resolution Mixture; Cyclosporine System Suitability Mixture; OL 27-400 Resolution Mixture; Sandimmune Resolution Mixture; [R-[R*,R*-(E)]]-Cyclosporin A Resolution Mixture
EINECS	Contact for details

Quality Control

Our Cyclosporine Resolution Mixture is produced under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC purity analysis and spectroscopic identification, to ensure it meets the exacting standards required for analytical reference materials. A detailed Certificate of Analysis (COA), providing batch-specific data, is supplied with every unit to guarantee traceability and compliance with research and pharmacopoeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term stability, store under inert atmosphere if the container is opened frequently.

Specification

Item	Specification
Appearance	White to off-white powder or solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0% (Total of Cyclosporine A and specified related compounds)
Related Substances (HPLC)	Meets specified limits for individual and total impurities
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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