Description

Pegcetacoplan is a targeted C3 complement inhibitor, representing a significant advancement in therapeutic peptides for the treatment of complement-mediated disorders. Its primary value lies in its precise mechanism of action, offering a potent and specific therapeutic option for conditions driven by dysregulated complement activity. This high-purity active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers and research institutions developing treatments for paroxysmal nocturnal hemoglobinuria (PNH), geographic atrophy (GA), and other complement-related diseases.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of injectable therapeutics for complement-mediated diseases.
• Paroxysmal Nocturnal Hemoglobinuria (PNH) Treatment: Core component in therapies designed to control intravascular hemolysis in PNH patients.
• Geographic Atrophy (GA) Treatment: Used in ophthalmic formulations targeting the progression of GA secondary to age-related macular degeneration (AMD).
• Biomedical Research: Critical reference standard and investigational material for studying the complement cascade (C3 pathway) in vitro and in vivo.
• Drug Discovery & Development: Serves as a lead compound or benchmark for developing next-generation complement inhibitors.
• Clinical Trial Material (CTM): Manufactured under GMP guidelines for use in Phase I-III clinical studies.

Basic Information

Product Name	Pegcetacoplan
CAS No.	2019171-69-6
Molecular Formula	C₂₀₈H₃₂₀N₅₄O₆₈
Molecular Weight	Approx. 4840 g/mol (Pegylated form)
Synonyms	APL-2; APL 2; Pegylated Compstatin Derivative; C3 Inhibitor Peptide; EMPAVELI (Brand Name); ASPAVELI (Brand Name); Complement C3 Inhibitor; Compstatin-PEG
EINECS	Contact for details

Quality Control

Our Pegcetacoplan is manufactured under strict quality management systems, adhering to current Good Manufacturing Practice (cGMP) guidelines for active pharmaceutical ingredients. Each batch undergoes comprehensive analytical testing to ensure identity, purity, potency, and safety. Key parameters include peptide content, pegylation homogeneity, and stringent control of related substances and residual solvents. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. This product is hygroscopic (moisture-sensitive). For long-term storage, keep desiccated. Under these conditions, the product is stable for at least 24 months from the date of receipt. Allow the vial to warm to room temperature before opening to minimize moisture condensation.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or solid
Identification (HPLC/MS)	Conforms to reference standard
Assay (HPLC)	≥ 98.0% (on anhydrous and solvent-free basis)
Purity (Related Substances, HPLC)	Total impurities ≤ 2.0%
Single Maximum Unknown Impurity	≤ 1.0%
Water Content (KF)	≤ 5.0%
Acetic Acid Content (HPLC)	≤ 10.0%
Bacterial Endotoxins	< 10 EU/mg
Sterility (where applicable)	Sterile

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