Exenatide Acetate

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Basic Information

CAS No

C184H282N50O60S
Place of Origin

Jilin, China (Mainland)
Type

Endocrine System Agents
Appearance

white powder
Purity

98.0%

Brief description

white powder Exenatide Acetate

Detailed description

Specifications

1. white powder
2. used for a treatment of type 2 diabetes
3. the mechanism is similar to that of GLP-1

Exenatide, an incretin mimic peptide comprised of 39 amino acid residue, is a new antidiabetic drug approved by FDA in 2005 for the treatment of diabetes mellitus type 2.

The main physiological functions are followings: promote insulin excretion in glucose-dependence manner, restoration of glucose sensitivity to the islets, inhibition of apoptosis of existing cells and increase the number of β cells, inhibition of gastric emptying leads to decreased food intake and reduced body weight. The exenatide therapy has the following advantages to compare with insulin therapy: no hypoglycemia effect, reducing body weight, improving insulin resistance, promoting islets cell function of patients.

Exenatide is developed and marketed (brand name Byetta) by Amylin Pharmaceuticals and Eli Lilly and Company. Due to some historical reasons, there is no compound patent for the drug in many countries. The API of the drug and generics have been developed and currently under clinical trial in China. Beyel Pharmaceutical is capable of manufacturing Exenatide Acetate by solid phase synthesis under GMP compliance.

Essential information

Amino acid sequence:

H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln–Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH₂

Molecular formula: C₁₈₄H₂₈₂N₅₀O₆₀S

Molecular weight: 4186.61

Quality standard-1

Appearance: White powder

Water content (Karl Fischer): ≤5%

Acetate content (HPLC method):≤5%

Amino acid composition: ±10% theoretical value

Purity (by two HPLC methods): ≥99.0%

Single impurity (by two HPLC methods): ≤0.5%

Total impurity (by two HPLC methods): ≤1.0%

Peptide content (Kjeldahl method): ≥85%

Assay (anhydrous, without acetate): 95%-103%

Bacterial endotoxins: ≤5EU/mg

Package: plastic bottle (peptide special) or glass vial

Short-term storage: avoid from moisture and light at 2-8°C

Long-term storage: avoid from moisture and light at -20°C

Period of validity: 2.0 years

Quality standard-2

Appearance: White powder

Water content (Karl Fischer): ≤7%

Acetate content (HPLC method): ≤7%

Amino acid composition: ±10% theoretical value

Purity (by two HPLC methods): ≥98.0%

Single impurity (by two HPLC methods): ≤1.0%

Total impurity (by two HPLC methods): ≤2.0%

Peptide content (Kjeldahl method): ≥85%

Assay (anhydrous, without acetate): 95%-103%

Bacterial endotoxins: ≤5EU/mg

Package: plastic bottle (peptide special) or glass vial

Short-term storage: avoid from moisture and light at 2-8°C

Long-term storage: avoid from moisture and light at -20°C

Period of validity: 2.0 years

Exenatide Acetate

Company Profile

Established in 2004, our company is located in the High & New Technology Development Zone of Changchun City in Northeast China. Our company is a biopharmaceutical enterprise engaged in the research, development, production and marketing of vaccines, biologics and peptide & chemical drugs.

There are two products of Varicella Vaccines (live) and Human-use Rabies Vaccines (Vero cell) in Chinese market. The sales amount of Varicella Vaccines in 2009 reached RMB220 million and the sales amount of Rabies Vaccines is growing constantly in 2010. A new vaccine being developed in our company against HIV for the prevention of epidemic disease of Aids is in phase II clinical trial in China. Furthermore, a peptide drug for the treatment of diabetes mellitus is on clinical trial and is estimated to be introduced to Chinese market in 2012. In addition, our company has a wide range of projects at different stages in a variety of therapeutic areas and a strong product pipeline, aiming at launching several more vaccines, biologics, peptide and chemical drugs in the coming years.

Since our establishment, our company has been emphasizing building up our cutting-edge technology with the most dedicated and talented scientists and state-of-the-art equipment and facilities. Each year, our company invests a considerable amount of money from the sales turnover in R&D to develop innovative and qualified healthcare products.

About 70 researchers among our 500 staff members are with university education or with postgraduate study in multi-disciplines of chemistry, biology and medicine. Most of them have been working in project R&D and product manufacture in biopharmaceutical industry for many years with adorable experience and expertise. A number of members in the management team and senior consultants have been educated and working in pharmaceutical companies in the USA and Europe. Besides, our company has cooperated with several well-known universities and research institutes in China and in the world to enforce and promote our innovative platform. The long relationship and close dialogues with SFDA (State Food and Drug Administration of China) ensure our products have great development and best fulfill all regulatory requirements in the market.

Changchun BCHT Biotechnology Co. has facilities of laboratories under GLP or GMP management for research, pilot plants for scaling up and factories for product manufacture. The R&D facilities, with an area over 2000sqm and more than 200 sets of instruments, include clear rooms, dark rooms, PCR rooms and laboratories for synthesis, purification, fermentation, analysis, in-vitro tests and animal tests, providing advanced means for our company to develop vaccines and peptide & chemical drugs. The pilot plants, with an area over 3500sqm and more than 300 sets of equipment, allow our company to carry out and promote the promising candidates of products from laboratory to massive production lines in factories. We have three production subsidiaries: BCHT Biopharma for the production of Varicella Vaccines (live), Maifeng Biopharma for the production of Rabies Vaccines and Baiyi Pharma for the production of peptide and chemical drugs in the future, currently under construction and GMP management by FDA for API manufacture.

Noteworthily, Changchun BCHT Biotechnology Co. has an extensive sales network and organization in China for marketing our products.

We sincerely wish to find competitive partners worldwide on technology cooperation and product co-promotion in any possibly creative form, establishing win-win partnerships and achieving bilateral commercial success with customers.

Our mission is as the abbreviation in our company's name - BCHT: "Biotech Creates a Healthy Tomorrow for the mankind".