Description

Cyclosporin Impurity 28 (005-95) is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Cyclosporin A, a vital immunosuppressive drug, by enabling accurate identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on method development, validation, and quality control in drug substance and product analysis.

Application

• Pharmaceutical Quality Control (QC): Serves as a certified reference standard for the identification and quantification of impurities in Cyclosporin A active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Cyclosporin A formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development (R&D): Used in metabolic and pharmacokinetic studies to understand the degradation pathways of Cyclosporin A.
• Calibration Standard: Acts as a precise calibrant for ensuring the accuracy and reliability of analytical instrumentation used in impurity testing.

Basic Information

Product Name	Cyclosporin Impurity 28 (005-95)
CAS No.	1907654-63-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cyclosporin A Impurity 28; Cyclosporine Impurity 28; CsA Impurity 28; UNII-005-95; (005-95); Cyclosporin Related Compound 28; Cyclosporin Derivative 28
EINECS	Contact for details

Quality Control

Every batch of Cyclosporin Impurity 28 (005-95) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, MS, and NMR to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 2.0%
Water Content (KF)	≤ 5.0%

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