Description

Alirocumab is a fully human monoclonal antibody (mAb) specifically designed to inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9). This targeted action is critical for lowering low-density lipoprotein cholesterol (LDL-C) levels in patients with hypercholesterolemia. It is a vital active pharmaceutical ingredient (API) for the formulation of advanced lipid-lowering injectable therapies. Pharmaceutical manufacturers and research organizations globally require this high-purity compound for drug development and production.

Application

• Primary Pharmaceutical API: Core active ingredient in the manufacture of PCSK9 inhibitor injectables for treating familial hypercholesterolemia and clinical atherosclerotic cardiovascular disease.
• Biosimilar Development: Reference standard and starting material for companies developing biosimilar versions of PCSK9 inhibitor therapies.
• Clinical Research: Used in preclinical and clinical trial materials to study efficacy, pharmacokinetics, and new therapeutic indications.
• Formulation R&D: Essential for stability studies, excipient compatibility testing, and development of final drug product formulations (e.g., pre-filled syringes, auto-injectors).
• Quality Control & Analytical Standards: Serves as a reference standard for identity, purity, and potency testing (e.g., HPLC, bioassay) in quality control laboratories.
• Biopharmaceutical Research: Tool compound for investigating PCSK9 biology, LDL receptor metabolism, and novel pathways in cardiovascular disease.

Basic Information

Item	Details
Product Name	Alirocumab
CAS No.	1245916-14-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	REGN727; SAR236553; Anti-PCSK9 Monoclonal Antibody; Praluent® (Brand Name API); Evolocumab (Isotype control/related mAb); Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor; Human IgG1, anti-(human PCSK9) (monoclonal REGN727 heavy chain), disulfide with monoclonal REGN727 light chain, dimer
EINECS	Contact for details

Quality Control

Our Alirocumab is manufactured and controlled under a strict quality management system. Each batch undergoes comprehensive analytical testing to ensure identity, purity, potency, and safety, meeting the stringent requirements for pharmaceutical active substances. Certificates of Analysis (COA) are provided, detailing results for critical quality attributes such as assay, related proteins, host cell proteins, and endotoxins.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store frozen at -20°C to -80°C. Avoid repeated freeze-thaw cycles. Under these conditions, the product remains stable for the duration specified on the certificate of analysis.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (HPLC/MS)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 98.0% (Monomer)
Assay (UV Spectroscopy)	90.0% - 110.0% of label claim
Protein Content	As per COA
Biological Activity (Binding ELISA)	Conforms to reference standard
Endotoxins (LAL)	< 1.0 EU/mg
Host Cell Proteins (HCP ELISA)	< 100 ppm
Sterility (Membrane Filtration)	Sterile

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