Description

Pembrolizumab CAS NO 1374853-91-4 is a high-purity, humanized monoclonal antibody (mAb) that functions as a programmed cell death protein 1 (PD-1) immune checkpoint inhibitor. This compound is of critical importance in modern oncology for its role in enhancing the body's immune response against tumor cells. It is an essential active pharmaceutical ingredient (API) primarily required by pharmaceutical manufacturers, biotechnology companies, and advanced research institutions developing and producing innovative cancer immunotherapies.

Application

• Oncological Pharmaceutical Manufacturing: As the key active pharmaceutical ingredient (API) in the formulation of injectable cancer immunotherapies.
• Biosimilar Development: Serves as a reference standard and starting material for companies developing biosimilar versions of PD-1 inhibitor therapies.
• Clinical Research & Pre-clinical Studies: Used in laboratory research to investigate mechanisms of immune checkpoint blockade and combination therapies.
• Bioconjugation & Drug Delivery Systems: A candidate for advanced drug delivery platforms, including antibody-drug conjugates (ADCs) and targeted nano-carriers.
• Quality Control & Analytical Testing: Employed as a certified reference standard in HPLC, bioassay, and other analytical methods for product release testing.
• Regulatory Submissions: Provides the necessary high-quality material for stability studies and documentation required for regulatory filings (e.g., FDA, EMA).

Basic Information

Product Name	Pembrolizumab
CAS No.	1374853-91-4
Molecular Formula	C6504H10004N1716O2036S46
Molecular Weight	Approx. 146.3 kDa
Synonyms	MK-3475; Lambrolizumab; Pembrolizumab (USAN/INN); Anti-PD-1 Monoclonal Antibody; Keytruda® (Brand Name API); PD-1 Inhibitor Antibody; Humanized IgG4-kappa Anti-PD-1 Antibody; SCH 900475
EINECS	Contact for details

Quality Control

Our Pembrolizumab is manufactured under strict quality management systems. Each batch is subjected to a comprehensive battery of analytical tests to ensure identity, purity, potency, and safety, meeting the stringent requirements for pharmaceutical active ingredients. Certificates of Analysis (COA) detailing specifications for purity (by SEC-HPLC and CE-SDS), biological activity (cell-based bioassay), endotoxin levels, and host cell protein content are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at -20°C to -70°C. Avoid repeated freeze-thaw cycles. The product is hygroscopic (moisture-sensitive); ensure containers are sealed under controlled, dry conditions after each use.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (Mass Spec)	Conforms
Purity (SEC-HPLC)	≥ 98.0% (Monomer)
Purity (CE-SDS, Reduced)	≥ 95.0% (Main Peak)
Assay (Protein Content)	90.0% - 110.0% of label claim
Potency (Cell-based Bioassay)	90% - 125% of reference standard
Endotoxin	< 1.0 EU/mg
Host Cell Protein (HCP)	< 100 ppm
pH	5.5 - 6.5 (for solution)

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