Nomen:Leuprolide Acetate,Leuprorelin Acetate, Leuproreline Acetate, Leuprorelinum Acetate
Cas No:74381-53-6
Formulae: C61H88N16O14
Molecular:1269.45
Sequentia: Pyr-Eii-Trp Ser-Tyr-D-Leu-Leu-Arg-Pro-NHEt sal acetatis.
Puritas:98%
Aspectus: cerussa
Leuprolide acetas synthetica nonapeptida est quae potens gonadotropin-hormone receptor solvens (GnRHR) agonist propter diversas applicationes orci, inter curationem cancer prostatae, endometriosis, fibroids vteri, centralis praecocus pubertatis et in vitro fecundatio ars. Ut basic mechanism agendi, leuprolide acetas gonadotrope secretionem hormonum luteinizing ac folliculum hormonum excitat, quae deinde productionem steroidem gonadalarum sexum supprimit.. Insuper, acetas leuprolide statim temptatur pro curatione morbi praefecti, ovarium polycysticum syndrome, eget alvum morbo, statura brevis, premenstrual syndrome et etiam ut jocus ad contraceptionem. Ascensus probationes suggerit GnRH agonistam suppressionem serum gonadotropinorum etiam momenti esse in multis applicationibus clinicis supra descriptis.. Praeterea, praesentia GnRHR in multitudine fibrarum non generativarum incluso recenti inventionis GnRHR expressionis in hippocampi et cortex cerebri humani indicat GnRH analogs ut acetas leuprolides etiam per textus GnRHRs directe agere possit ad modulandum. (cerebrum) munus. Sic, mechanismi hypothetici subiacent effectum therapeuticum GnRH analogorum in curatione horum morborum magis implicatum esse quam primum cogitationem.. Hae observationes etiam suadeant potentias usus GnRH analogs in modulatione GnRH significandi et curationis morborum adhuc plene impleri..
1.Leuprorelin in curatione carcinomata hormona-responsiva ut cancer prostatae et carcinomati similis. Potest etiam adhiberi ad condiciones dependens estrogen-dependens ut endometriosis vel fibroides uterinae.
2.Potest adhiberi ad pubertatem praecoquens in masculis et feminis, et ne ovulation praematura in cyclis ovarii stimulationis moderati pro in vitro fecundationis (IVF).
3.Leuprore.lin, una cum triptore, Saepe pubertatem in transgender adolescentia morari solebant, donec per aetatem incipere hormone replacement illic. Solent etiam interdum ut superiores optiones anti-androgens sicut spironolac.tono et cyproterone acetate ad suppressionem testi osteronis productionis in trans mulieres..
| ITEMS |
SPECIFICATION |
RESULT |
| Aspectus |
Pulvis albus |
Conforms |
| Solubilitas |
Solutum in aqua vel 1% acetic acid at a *
coniunctis ≥1mg / ml dare manifesta,
hyalina solution |
Conforms |
| Identity |
A. ET'
Idem cum spectro Leuprolideo
B. HPLC
Etiam cum solutione referat
C. Amino Acidum Analysis
Esse: Present
Glu: 0.85~1.1
Pro: 0.85~1.1
Leu: 1.80~2.2
Tyr: 0.85~1.1
His: 0.85~1.1
Arg: 0.85~1.1
Trp: Present |
Conforms
Conforms
0.84
0.97
1.04
2.02
1.01
0.99
1.00
present |
| Imprimis Rotatione Optica |
-38.0~-42.0° [a]20D(c=1.1% HAc) |
-39.2° |
| RelatedSubstance
(per HPLC) |
Totalis immunditias(%)≤2.5%
acetyl-leuprolide≤1.0%
D-Eius-leuprolide≤0.5%
L-Leu6-leuprolide≤0.5%
D-Ser-leuprolide≤0.5%
Alia alia Impurity≤0.5% |
0.21%
Conforms
Conforms
Conforms
Conforms
0.2% |
| Acetate Content(per HPLC) |
4.7~9.0% |
8.7% |
| Aqua Content(Carolus Fischer) |
≤5.0% |
1.4% |
| Cinis sulphate |
≤0.3% |
Conforms |
| Bacterial Endotoxins |
≤16.7 IU/mg |
Conforms |
| Residua Organic Solvents |
Acetonitrile ≤0.041%(per GC)
DMF ≤0.088%(per GC)
MEOH ≤0.3%(per GC)
TFA ≤0.1%(per HPLC) |
Conforms
Conforms
Conforms
Conforms |
| Assay(per Anhydrous, Acidum aceticum-liberum ) |
97.0~103.0% |
98.10% |
