Triptorelin Acetate - Exportimes.com

Supplier Details

Changchun BCHT Biotechnology Co.  

Year Established:2004

Business Type:Business Service

Management Certifiation: GMP

Operational Address:

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Triptorelin Acetate

Triptorelin Acetate
  • Triptorelin Acetate
  • Triptorelin Acetate
  • Triptorelin Acetate
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white powder Triptorelin Acetate

Product Details

Parameter

MF : C64H82N18O13
Place of Origin : Jilin, China (Mainland)
Appearance : white powder
purity : 8.0%

Description

Specifications

1. lyophilization
2. white powder
3. agonist of GnRH receptor
4. API
5. high quality

  Triptorelin is a decapeptide drug derived from gonadotrophin releasing hormone (GnRH) by the replacement of Gly6 with D- tryptophan in the amino acid sequence. Triptorelin is an agonist of GnRH receptor with higher potency and longer plasma half-life compared with its natural counterpart. After injection, Triptorelin stimulates putative to release luteinizing hormone (LH) and follicle-stimulating hormone (FSH), while the causing constant stimulation of putative leads it into refractory period that  reduces the release of Gonadotrophin and thus results in the sex steroid (testosterone or estrogen) to emasculation level. Furthermore, the above physiological process is reversible.

  In clinical, Triptorelin is used for the treatment of the hormone-responsive conditions by lowering the sex steroid hormones in serum to the emasculation level. For instance, it has been applied for medication of androgen-dependent prostatic cancer; endometriosis, fibroid and assisted reproduction.

  Triptorelin has been marketed in many countries. Beyel Pharmaceuticals is capable of manufacturing the drug API Triptorelin Acetate under GMP compliance.

 Essential information

Molecular formula: C64H82N18O13

Molecular weight: 1311.46

Amino acid sequence:

Glp-His-Trp-Ser-Tyr-D-Trp-Leu-Arg-Pro-Gly-NH2

 Quality standard

1,Appearance: white powder

2,Water content (Karl Fischer): ≤8%

3,Acetate content (HPLC method): ≤10%

4,Amino acid composition: ±10% theoretical value

5,Purity (by two HPLC methods): ≥98.0%

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

7,Total impurity (by two HPLC methods): ≤2%

8,Peptide content (Kjeldahl method): ≥80%

9,Assay (anhydrous, without acetate): 95%-105%

10,Bacterial endotoxins: ≤5EU/mg

Pack: 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

Triptorelin 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".

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