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74381-53-6 Leuprorelin acetate Antitumor drugs (hormones)
It is given by injection into a muscle or under the skin.
ITEMS |
SPECIFICATION |
Appearance |
White powder |
Solubility |
Soluble in water or 1% acetic acid at a concentration of ≥1mg/ml to give a clear, colorless solution |
Identity |
A. IR Same with the reference spectrum of Leuprolide B. HPLC Same with the reference solution C. Amino Acid Analysis Ser: 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 |
Specific Optical Rotation |
-38.0~-42.0° [a]20D(c=1,1% HAc) |
RelatedSubstance (By HPLC) |
Total Impurities(%)≤2.5% acetyl-leuprolide≤1.0% D-His-leuprolide≤0.5% L-Leu6-leuprolide≤0.5% D-Ser-leuprolide≤0.5% Any other Impurity≤0.5% |
Acetate Content(By HPLC) |
4.7~9.0% |
Water Content(Karl Fischer) |
≤5.0% |
Sulphate ash |
≤0.3% |
Bacterial Endotoxins |
≤16.7 IU/mg |
Residual Organic Solvents |
Acetonitrile ≤0.041%(By GC) DMF ≤0.088%(By GC) MEOH ≤0.3%(By GC) TFA ≤0.1%(By HPLC) |
Assay(By Anhydrous, Acetic Acid-free ) |
97.0~103.0% |
Leuprorelin may be used in the treatment of hormone-responsive cancers such as prostate cancer and breast cancer. It may also be used for estrogen-dependent conditions such as endometriosis or uterine fibroids.
It may be used for precocious puberty in both males and females, and to prevent premature ovulation in cycles of controlled ovarian stimulation for in vitro fertilization (IVF).
Leuprorelin, along with triptorelin and goserelin, are often used to delay puberty in transgender youth until they are old enough to begin hormone replacement therapy. They are also sometimes used as superior alternatives to anti-androgens like spironolactone and cyproterone acetate for suppressing test osterone production in trans women.
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