Description

Evolocumab is a human monoclonal antibody (IgG2) that selectively binds to proprotein convertase subtilisin/kexin type 9 (PCSK9), inhibiting its interaction with the low-density lipoprotein receptor (LDLR) and thereby enhancing LDL cholesterol clearance from the bloodstream. As a biopharmaceutical agent of high therapeutic significance, it delivers clinically proven efficacy in reducing cardiovascular risk for patients with hypercholesterolemia and familial hypercholesterolemia. It is essential for pharmaceutical R&D, biosimilar development, reference standard preparation, and analytical method validation in global biologics manufacturing and regulatory laboratories. Evolocumab CAS NO 1256937-27-5 is supplied as a lyophilized powder or solution under stringent GMP-aligned conditions for research and development use.

Application

• Reference standard for HPLC, LC-MS, and ELISA assay development and calibration
• Active pharmaceutical ingredient (API) sourcing for biosimilar development programs
• Stability-indicating method validation in quality control laboratories
• Pharmacokinetic and pharmacodynamic (PK/PD) study material in preclinical and clinical research
• Calibration and qualification of biosafety testing platforms (e.g., host cell protein assays)
• Development of anti-drug antibody (ADA) detection assays
• Comparability studies during process changes or site transfers
• Regulatory submission support (e.g., ICH Q5, Q6B compliance documentation)

Basic Information

Product Name	Evolocumab
CAS No.	1256937-27-5
Molecular Formula	C6572H10124N1728O2012S44 (approx. for IgG2 monoclonal antibody; exact mass varies by glycoform)
Molecular Weight	~149,000 Da (monomeric, reduced; varies with glycosylation)
Synonyms	AMG 145; Repatha® (brand name); PCSK9 inhibitor monoclonal antibody; Anti-PCSK9 mAb; Evolocumab injection; Human anti-PCSK9 IgG2 monoclonal antibody; LY3015014; CVR-201; PCSK9-neutralizing antibody; Recombinant human IgG2 kappa anti-PCSK9
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. Testing includes identity confirmation (peptide mapping, intact mass analysis), purity assessment (SEC-HPLC, CE-SDS), potency (cell-based PCSK9 binding/inhibition assay), and sterility/endotoxin testing per USP <71> and <85>. All lots meet specifications aligned with ICH Q5, Q6B, and Q5C guidelines for biotechnological/biological products.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8°C for liquid formulations; lyophilized powder should be stored at –20°C or below. Protect from moisture due to hygroscopic nature. Avoid repeated freeze-thaw cycles. Maintain under inert atmosphere if reconstituted and stored long-term.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear, colorless to pale yellow solution
Identification (Peptide Mapping)	Conforms to reference standard
Identification (Intact Mass)	±0.1% of theoretical mass (by LC-MS)
Assay (by SEC-HPLC)	≥95.0%
Aggregates (by SEC-HPLC)	≤5.0%
Fragmentation (by CE-SDS)	≤3.0%
Endotoxin	≤5.0 EU/mg
Sterility	Complies with USP <71>
pH (reconstituted)	5.0–6.5
Residual Solvents	Meets ICH Q3C limits

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