Product name Leuprorelin
Product No. 600615
Sequence Glp-His-Trp-Ser-Tyr-D-Leu-Leu-Arg-Pro-NHEt
Appearance White or almost white powder
Solubility Soluble in water ,1% acetic acid
Specific Optical Rotation (-38.0°to -42.0°)(anhydrous and acetic acid free substance)
Water ≤8.0%
Amino acid analysis Arg:0.85-1.10;His:0.85-1.10
Leu:1.80-2.20;Pro:0.85-1.10
Tyr:0.85-1.10;Glu:0.85-1.10
Ser: Present No more than the traces of the other amino acids are present, with the exception of tryptophan.
Related substances Any impurity: NMT 0.5% Total impurity: NMT 2.0%
Assay 97.0%-103.0% (anhydrous and acetic acid free substance)
Acetate acid 4.7%-9.0%
MS 1209.4 ± 1.0
Bacterial endotoxins <16.7IU/mg
Storage Condition In an air tight container, protected from light at temperature 2-8℃.
Leuprorelin Acetate is for the treatments of Endometriosis; uterine fibroids with menorrhagia, lower abdominal pain, low back pain and anemia; premenopausal breast cancer, and estrogen receptor-positive patients; prostate cancer; central precocious puberty. Clinical mainly for prostate cancer and endometriosis.
Originator Companies:TAP (Takeda Abbott Phamaceuticals), and Abbott
Dosage for finished formulation: 1.8mg or 3.75mg
Mechanism of action: Leuprorelin acts as an agonist at pituitary GnRH receptors. By interrupting the normal pulsatile stimulation of, and thus desensitizing, the GnRH receptors, it indirectly downregulates the secretion of gonadotropins luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to hypogonadism and thus a dramatic reduction in estradiol and testosterone levels in both sexes.
Product No. 600615
Sequence Glp-His-Trp-Ser-Tyr-D-Leu-Leu-Arg-Pro-NHEt
Appearance White or almost white powder
Solubility Soluble in water ,1% acetic acid
Specific Optical Rotation (-38.0°to -42.0°)(anhydrous and acetic acid free substance)
Water ≤8.0%
Amino acid analysis Arg:0.85-1.10;His:0.85-1.10
Leu:1.80-2.20;Pro:0.85-1.10
Tyr:0.85-1.10;Glu:0.85-1.10
Ser: Present No more than the traces of the other amino acids are present, with the exception of tryptophan.
Related substances Any impurity: NMT 0.5% Total impurity: NMT 2.0%
Assay 97.0%-103.0% (anhydrous and acetic acid free substance)
Acetate acid 4.7%-9.0%
MS 1209.4 ± 1.0
Bacterial endotoxins <16.7IU/mg
Storage Condition In an air tight container, protected from light at temperature 2-8℃.
Leuprorelin Acetate is for the treatments of Endometriosis; uterine fibroids with menorrhagia, lower abdominal pain, low back pain and anemia; premenopausal breast cancer, and estrogen receptor-positive patients; prostate cancer; central precocious puberty. Clinical mainly for prostate cancer and endometriosis.
Originator Companies:TAP (Takeda Abbott Phamaceuticals), and Abbott
Dosage for finished formulation: 1.8mg or 3.75mg
Mechanism of action: Leuprorelin acts as an agonist at pituitary GnRH receptors. By interrupting the normal pulsatile stimulation of, and thus desensitizing, the GnRH receptors, it indirectly downregulates the secretion of gonadotropins luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to hypogonadism and thus a dramatic reduction in estradiol and testosterone levels in both sexes.