Description

Trastuzumab Emtansine is a targeted antibody-drug conjugate (ADC) designed for the treatment of specific cancers. This innovative therapeutic combines the monoclonal antibody trastuzumab with the cytotoxic agent DM1 (emtansine) to deliver potent chemotherapy directly to HER2-positive tumor cells. It is a critical active pharmaceutical ingredient (API) for pharmaceutical manufacturers developing advanced oncology treatments. The product is supplied as a high-purity compound for research and commercial drug product synthesis.

Application

• Primary active pharmaceutical ingredient (API) in the manufacture of the oncology drug Kadcyla® (ado-trastuzumab emtansine).
• Key intermediate in the research and development of novel antibody-drug conjugate (ADC) therapies.
• Reference standard for quality control and analytical method development in pharmaceutical laboratories.
• Bioconjugation studies for exploring new linker-payload technologies in targeted cancer therapy.
• Preclinical and clinical research focusing on HER2-positive cancers, including breast and gastric cancers.

Basic Information

Product Name	Trastuzumab Emtansine
CAS No.	1018448-65-1
Molecular Formula	C6448H9948N1720O2014S44
Molecular Weight	Approx. 148,700 g/mol (Contact for exact lot-specific details)
Synonyms	Ado-Trastuzumab Emtansine; Trastuzumab-DM1; T-DM1; Trastuzumab Emtansine Conjugate; Trastuzumab-MCC-DM1; Genentech Drug Code: RO5304020; Kadcyla API; Anti-HER2 ADC
EINECS	Contact for details

Quality Control

Our Trastuzumab Emtansine is manufactured and controlled under a strict quality management system. Each batch is subjected to a comprehensive suite of analytical tests to ensure identity, purity, potency, and consistency, meeting the stringent requirements for pharmaceutical active ingredients. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting compliance with agreed specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. This product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a dry environment before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or solid
Identification (HPLC/MS)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 95.0% (Monomer)
Drug-to-Antibody Ratio (DAR)	3.3 - 3.9 (by UV-HPLC or HIC-HPLC)
Protein Content (UV)	90.0 - 110.0 % of label claim
Free DM1 / Small Molecule Content	≤ 2.0 %
Potency (Cell-based assay)	Within specified range
Endotoxin	< 10 EU/mg
Residual Solvents (GC)	Meets ICH Q3C guidelines

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