Trastuzumab

1. Product Name:Trastuzumab 2. CAS No.: 180288-69-1 3. Speicification: Injection 4. Protein content: more than 25mg/ml

5. Specification of Trastuzumab

Items	Specifications	Results
Protein content	≥25mg/ml	31.35mg/ml
Bioactivity	80~150% of reference standard	116%
Purity SDA-PAGE electrophoresis	the total purity of light and heavy chain should be not less than 95.0%	98.8%
Purity SEC-HPLC	The monomer purity should be not less than 98.0%	99.6%
Molecular weight	Heavy chain: 45.0%~55.0 kD Light chain: 20.0~28.0 kD	50.1 kDa 26.3 kDa
Isoelectric point	It should be identical to that of reference standard	Conform to
Exogenous DNA residual	≤10pg/mg protein	Conform to
CHO cell protdin residual	≤ 0.03% of total protein	0.00001%
Bacteria endotoxin	<0.2EU/mg protein	< 0.1EU/mg protein
Peptide map	It should be identical to that of reference standard	Conform to
Recombinant protein A residual	≤0.005% of totalo protein	Conform to
N-terminal amino acid sequence	Light chain : Asp-IIn-Gln-Met-Thr-Gln-Ser-Pro-Ser-Leu-Ser-Ala-Ser-Val Heavy chain:  Glu-Val-Gln-Leu-Val-Glu-Ser-Gly-Gly-Gly Leu-Val-Gln-Pro-Gly
Conclusion	this batch quality complies with the quality specification

6. Function  

Trastuzumab is a recombinant humanize anti-HER2 monoclonal antibody. it can attaches

 where HER2 attches. in order to protect the growth of Cancer cell, meanwhile. Trastuzumab 

also stimulate own immune cell to destroy Cancer cell. 

7. About cooperation

As a biosimilar with high-tech, sincerely hope we can delevop friendly and long-term cooperation for Trastuzumab  preparation. 

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Sinoway's Advantages:

(1) ISO 9001:2008 certificated company

(2) 26 years in pharmaceutical industry

(3) China office of Fischer Chemicals AG (Switzerland)

Trastuzumab