Description

Zilucoplan is a synthetic macrocyclic peptide inhibitor of complement component C5, designed for targeted therapeutic intervention in complement-mediated diseases. It delivers high-affinity, reversible blockade of C5 cleavage—preventing formation of pro-inflammatory C5a and membrane attack complex (C5b-9)—thereby addressing the root pathophysiology in conditions such as paroxysmal nocturnal hemoglobinuria (PNH) and generalized myasthenia gravis (gMG). This precision mechanism makes it critically valuable for pharmaceutical R&D, clinical trial supply, and commercial-scale API manufacturing. Zilucoplan CAS NO 1841136-73-9 is supplied as a high-purity active pharmaceutical ingredient meeting stringent regulatory expectations for biologics-adjacent small-molecule therapeutics.

Application

• Active Pharmaceutical Ingredient (API) for clinical development and commercial manufacturing of anti-complement therapies
• Preclinical and clinical reference standard for pharmacokinetic, pharmacodynamic, and bioanalytical method validation
• Research tool for mechanistic studies of terminal complement pathway inhibition in autoimmune and inflammatory disease models
• Key compound in stability-indicating assay development (e.g., forced degradation studies under oxidative, humid, and photolytic stress)
• Starting material or intermediate in synthetic route optimization for next-generation C5 inhibitors
• Calibration standard for LC-MS/MS and HPLC-based quantification in biological matrices (serum, plasma)

Basic Information

Product Name	Zilucoplan
CAS No.	1841136-73-9
Molecular Formula	C91H133N25O22
Molecular Weight	2038.22 g/mol
Synonyms	Zilucoplan; RA101495; RA-101495; RA 101495; Zilucoplan sodium salt; Sodium zilucoplan; Zilucoplan (sodium); C5 inhibitor RA101495; [Nle1, Nle8, D-Phe12, Lys13(N-Me), D-Ala16]-Cyclo[Asn1-Pro2-Val3-Trp4-Leu5-Gly6-Leu7-Nle8-Tyr9-Thr10-Cys11-D-Phe12-Lys13-Asp14-Ala15-D-Ala16-Cys17]; Cyclo(Asn-Pro-Val-Trp-Leu-Gly-Leu-Nle-Tyr-Thr-Cys-D-Phe-Lys-Asp-Ala-D-Ala-Cys)-Nle1,Nle8,Lys13(N-Me)
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. All batches conform to ICH Q5, Q7, and Q9 guidelines and are manufactured under cGMP-compliant conditions. Testing includes identity (HPLC, IR, MS), assay (HPLC), related substances (HPLC), residual solvents (GC), water content (Karl Fischer), heavy metals (ICP-MS), and microbiological limits (where applicable). Purity is verified to be ≥99.0% by area normalization HPLC.

Storage

Preserve in a tightly closed container, protected from light. Store under inert atmosphere (argon or nitrogen) at -20°C for long-term stability. Due to its hygroscopic and easily oxidized nature, minimize exposure to ambient humidity and oxygen during handling. Allow to equilibrate to room temperature in a desiccator before opening.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Characteristic peaks consistent with reference spectrum
Assay (HPLC)	99.0–101.0% (on anhydrous basis)
Related Substances (HPLC)	Any single impurity ≤0.3%; Total impurities ≤1.0%
Water Content (KF)	≤5.0%
Residual Solvents (GC)	Meets ICH Q3C limits
Heavy Metals	≤10 ppm
Microbial Limits	Total aerobic count ≤100 CFU/g; Absence of E. coli, S. aureus, P. aeruginosa, and S. typhi

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