Evolocumab is a fully human monoclonal antibody and biological active pharmaceutical ingredient (API) used as a lipid-lowering agent. It is a PCSK9 inhibitor that lowers low-density lipoprotein cholesterol (LDL-C) by increasing the availability of LDL receptors on the surface of liver cells.
Evolocumab is used as an adjunct to diet and other lipid-lowering therapies for conditions including hypercholesterolemia and established atherosclerotic cardiovascular disease, according to applicable approved indications.
Evolocumab is a recombinant fully human IgG2 monoclonal antibody that specifically binds to proprotein convertase subtilisin/kexin type 9 (PCSK9).
By preventing circulating PCSK9 from binding to LDL receptors, Evolocumab reduces LDL-receptor degradation and increases hepatic clearance of LDL cholesterol from the bloodstream.
CAS Number: 1256937-27-5
Molecular Formula: Not applicable as a conventional small molecule; recombinant monoclonal antibody
Molecular Weight: Approximately 141.8 kDa
Evolocumab binds specifically to circulating PCSK9 and prevents PCSK9 from interacting with LDL receptors on hepatocytes.
Its pharmacological effects include:
Evolocumab is used in pharmaceutical formulations for:
The exact indication, age range, dosage and administration requirements depend on the approved product labeling and applicable regulatory authority.
Evolocumab is a biological API / recombinant monoclonal antibody drug substance, rather than a conventional chemically synthesized small-molecule API.
Quality characterization of Evolocumab generally includes evaluation of:
Pharmaceutical-grade Evolocumab should be manufactured under appropriate biopharmaceutical GMP controls and according to the applicable approved specification and regulatory requirements.
A qualified supplier should provide appropriate Certificate of Analysis (CoA), analytical characterization documentation, SDS/MSDS where applicable, batch traceability and regulatory documentation.
Evolocumab drug substance and finished formulations require controlled storage and handling conditions because monoclonal antibodies are sensitive to temperature excursions and physical stress. Storage conditions should follow the approved manufacturer's specification.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |