Description

Cyclosporin L Related Compound 2 CAS NO 104372-56-7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the accuracy and reliability of quality control testing in pharmaceutical development and manufacturing. It is primarily utilized by analytical laboratories, quality assurance departments, and research institutions working with immunosuppressant drugs and related metabolites.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Cyclosporin L and related impurities in drug substances and finished products.
• Analytical Method Development & Validation: Used as a critical component in developing, optimizing, and validating HPLC, UPLC, and LC-MS/MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand drug product behavior.
• Metabolite & Impurity Research: Facilitates research into the metabolic pathways, degradation products, and synthetic by-products of cyclosporine analogs.
• Regulatory Submissions: Provides essential data to support regulatory filings (e.g., FDA, EMA) by characterizing and controlling related substances.

Basic Information

Product Name	Cyclosporin L Related Compound 2
CAS No.	104372-56-7
Molecular Formula	C62H111N11O12
Molecular Weight	1202.6 g/mol
Synonyms	Cyclosporin L Impurity 2; Cyclosporin L Related Substance 2; [D-Ser]8-Cyclosporin A; Cyclosporin L Analog; Cyclosporin Derivative; Cyclosporin L Metabolite; Cyclosporine L Related Compound B
EINECS	Contact for details

Quality Control

Every batch of Cyclosporin L Related Compound 2 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and impurity profiling, to ensure compliance with pharmaceutical reference standard requirements. 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 at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
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.