
Chemical Name:Triptorelin Acetate
Synonyms:Decapeptyl, Gonapeptyl, Triptorelinum
CAS Number:57773-63-4
Molecular Formula:C₆₄H₈₂N₁₈O₁₃ · C₂H₄O₂
Molecular Weight:1311.46 g/mol (free base) + 60.05 g/mol (acetic acid) = 1371.51 g/mol (total)
Appearance:White to off-white powder
Solubility: Soluble in water, slightly soluble in ethanol
Storage Conditions :Store at 2-8°C, protected from light and moisture
Stability:Stable under recommended storage conditions
Pharmacological Class:Gonadotropin-releasing hormone (GnRH) agonist
Therapeutic Use:Treatment of prostate cancer, endometriosis, and central precocious puberty
Mechanism of Action:Initially stimulates, then suppresses the release of gonadotropins (LH and FSH)
Half-life:Approximately 2-4 hours (after subcutaneous or intramuscular injection)
Route of Administration:Subcutaneous or intramuscular injection

Triptorelin Acetate is a synthetic decapeptide analog of gonadotropin-releasing hormone (GnRH). It acts as a potent agonist of GnRH receptors, initially stimulating the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), followed by downregulation of these hormones. This makes it effective in treating conditions such as prostate cancer, endometriosis, and central precocious puberty. It is typically administered via injection and is available in various formulations, including immediate-release and sustained-release forms.

Parameter | Specification | Test Result | Method |
---|
Appearance | White or off-white powder | Complies | Visual inspection |
Identification | Complies with reference standard | Complies | HPLC, MS |
Assay (Purity) | ≥ 98.0% | [Insert Value] | HPLC |
Water Content | ≤ 6.0% | [Insert Value] | Karl Fischer titration |
Acetic Acid Content | 5.0% - 8.0% | [Insert Value] | Titration |
Related Substances | ≤ 2.0% (total impurities) | [Insert Value] | HPLC |
Heavy Metals | ≤ 10 ppm | [Insert Value] | ICP-MS |
Residual Solvents | Complies with ICH guidelines | Complies | GC |
Microbial Limits | Complies with USP <61> | Complies | Microbial testing |
Endotoxins | < 10 EU/mg | [Insert Value] | LAL test |
Remarks
The product complies with the specifications as per [Insert Pharmacopeia Standard, e.g., USP, EP, or JP].
Storage conditions: Store at 2-8°C, protected from light and moisture.
