Description

Trastuzumab Deruxtecan is an antibody-drug conjugate (ADC) designed for targeted cancer therapy, combining a monoclonal antibody with a potent cytotoxic payload. This innovative therapeutic agent is critical for the precise delivery of chemotherapy to specific cancer cells, thereby enhancing efficacy while potentially reducing systemic side effects. It is primarily required by pharmaceutical manufacturers, biotechnology research organizations, and clinical development facilities engaged in advanced oncology treatments.

Application

• Oncological Therapeutics: Primary active pharmaceutical ingredient (API) for the treatment of HER2-positive metastatic breast cancer, gastric cancer, and other solid tumors.
• Pharmaceutical R&D: Key reference standard and intermediate in the research and development of novel antibody-drug conjugates and targeted cancer therapies.
• Clinical Manufacturing: Used in the cGMP-compliant production of finished dosage forms, such as lyophilized powders or injectable solutions for clinical trials and commercial supply.
• Bioconjugation Studies: Serves as a model compound in studies focusing on linker technology, drug-to-antibody ratio (DAR) optimization, and ADC stability.
• Bioanalytical Development: Employed as a critical standard for method development and validation in pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity assays.

Basic Information

Product Name	Trastuzumab Deruxtecan
CAS No.	1826843-81-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	DS-8201; Trastuzumab Deruxtecan; Fam-Trastuzumab Deruxtecan-nxki; ENHERTU® (brand name); T-DXd; [fam-]Trastuzumab Deruxtecan; Anti-HER2 ADC DS-8201a; RC-000007
EINECS	Contact for details

Quality Control

Our Trastuzumab Deruxtecan is manufactured and controlled under strict quality systems suitable for pharmaceutical applications. Each batch undergoes comprehensive analytical testing, including purity by HPLC, determination of drug-to-antibody ratio (DAR), and assessment of aggregates and fragments. Certificates of Analysis (COA) documenting compliance with stringent in-house specifications are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. This product is hygroscopic (moisture-sensitive) and should be handled under controlled, dry conditions to maintain stability. For long-term storage, keep desiccated.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or solid
Identification (HPLC/MS)	Conforms to reference standard
Purity (HPLC)	≥ 98.0%
Drug-to-Antibody Ratio (DAR)	~8 (Specify range upon request)
Aggregates (SEC-HPLC)	≤ 2.0%
Potency (Cell-based assay)	Conforms to reference
Endotoxin	< 1.0 EU/mg
Residual Solvents (GC)	Meets ICH guidelines

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