Active Pharmaceutical Ingredient

Herceptin (Trastuzumab)

Also known as: Trastuzumab / Herceptin

CAS: 180288-69-1 Monoclonal Antibody / HER2 Antagonist IP / BP / EP / USP Bulk Supply Available
Herceptin (Trastuzumab) API Manufacturer India | Mediocon Inc
Herceptin (Trastuzumab) — Pharmaceutical Grade API

Product Overview

CAS No: 180288-69-1  |  MF: C₆₄₃₈H₉₉₁₄N₁₇₄₄O₁₉₈₆S₄₄  |  MW: ~148,000 g/mol

Trastuzumab (Herceptin) is a recombinant humanized monoclonal antibody targeting the HER2/neu receptor. It is used in the treatment of HER2-positive breast cancer and gastric cancer. Mediocon Inc supplies pharmaceutical-grade Trastuzumab API with full batch documentation.

Key Features

  • HER2/neu targeted monoclonal antibody
  • Recombinant humanized antibody
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation

Applications

  • HER2-positive breast cancer
  • HER2-positive metastatic gastric cancer
  • Adjuvant breast cancer therapy
  • Combination chemotherapy regimens

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameHerceptin (Trastuzumab)
Also Known AsTrastuzumab / Herceptin
CAS Number180288-69-1
Molecular FormulaC₆₄₃₈H₉₉₁₄N₁₇₄₄O₁₉₈₆S₄₄
Molecular Weight~148,000 g/mol
CategoryMonoclonal Antibody / HER2 Antagonist
AppearanceLyophilized White Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay≥95.0% (by SDS-PAGE)
Loss on DryingNMT 5.0%
Heavy MetalsNMT 20 ppm
pH6.0 – 7.0 (reconstituted)
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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