| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Non-Customized |
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Product Description
Introduction of Alirocumab:
Alirocumab is marketed under the Praluent brand and is a second-line treatment for high cholesterol in adults whose cholesterol is not controlled by diet and statin therapy. It is a human monoclonal antibody that belongs to a new class of anti-cholesterol drugs called PCSK9 inhibitors and is the first such drug to be approved by the FDA.
Function of Alirocumab:
1. Alirocumab is used to treat primary hyperlipidemia in adults
2. Reduce heart attack (myocardial infarction or MI)
|
1. Concentration |
60.0±6.0 mg/ml |
61.0 mg/ml |
|
2. pH value |
Corresponds to reference standard |
Pass |
|
3. Purity |
NLT 99.0% |
Pass |
|
3.1 Non-reduced CE-SDS |
Main peak NLT 90.0% |
98.4% |
|
3.2 SEC-HPLC |
Main peak NLT 95.0% |
99.1% |
|
4. Isoelectric Point |
Corresponds to reference standard |
Pass |
|
5. Bacterial Endotoxins Test |
<5 EU/ml |
<1 EU/ml |
|
6. Residual Proteins of Host Cell |
≤100 ng/mg |
1 ng/mg |
|
7. Exogenous Residual DNA |
≤100 pg/mg |
<1 pg/mg |
|
8. Residual protein A |
≤100 ng/mg |
<1 ng/mg |
|
9. Biological Activity |
Compared with standard, the range of biological activity is from 80% to 125%. |
113% |
|
10. Osmolality |
Corresponds to reference standard |
Pass |
|
11. Peptide mapping |
Corresponds to reference standard |
Pass |
|
12. N-terminal sequence |
Corresponds to reference standard |
Pass |
Packaging & Shipping.
| By Express | By Air | By Sea |
| Suitable for under 1kg | Suitable for more than 1kg | Suitable for more than 10kg |
| Fast: 3-7 days | Fast: 5-9 days | Slow: 10-30 days |
| High cost | Medium cost | Low cost |
| Door to door service | Port to port service | Port to port service |
Compnay Information
Shanghai HuiRui Chemical Technology Co., Ltd.(HuiCHem) is a high-tech enterprise engaged in the area of health care & nutrition. HuiChem have been working closely with our customers we deliver products and solutions that create value and competitive advantage while positively impacting the world we live in, as well as attentive service for the purpose to meet the demand of customers, spare no effort to create value for customers.
HuiChem is now headquartered in Shanghai, and has offices in Jiangsu, Shandong, Anhui and HongKong. Its Shanghai headquarters has nearly 2000 square meters of operation premises, including a total of over 1500 square meters of synthesis laboratories and more than 200 square meters of analysis laboratories (equipped with AAS, LC-MS, FTIR, NMR and other basic test equipment). We have set up two pilot scale laboratories, which lay speedy and stable foundation for process amplification and production of superior products. Besides, we have partner factories that are responsible for the commercial production in Jiangsu Province and Shandong Province. All of those, ensuring growing customer demand and smooth commercial production. We have been certified ISO9001:2008 and ISO14001:2004. The company has established good cooperative relationships with Shanghai Institute of Organic Chemistry of Chinese Academy of Sciences(SIOC), Shanghai Institute of Materia Medica (SIMM), University of Science and Technology of China and Fudan University, and carried out a variety of creative R&D cooperation activities.
We attach great importance to technical innovation and follow the latest dynamic of discovery and development to research and develop new products relying on advanced technology of synthetic chemistry, medicinal chemistry, biochemistry and analytical chemistry. We also pay attention to introduce and foster professional and technical personnel, the company has a group of vigorous and well-trained employees, and strong technical R&D forces. HuiChem has established a new system covering research and development, production and sales. Based on advanced equipment and strict management, always pursue the "open, inclusion, innovation, sharing" business philosophy, creating a win-win cooperation platform.
Everything originates from innovation. HuiChem combines the power of science and the passion of innovation. We believe to connect chemistry and innovation with the principles of sustainability to create a healthy life.
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