Triptorelin Acetate

1. lyophilization 2. white powder 3. manufactured under GMP compliance 4. high quality 5. SPPS

  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