Leuprolide Acetate 74381-53-6

97% up by HPLC, USP

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Product Information

Product name	Leuprolide Acetate
CAS No.	74381-53-6
Molecular Formula	C59H84N16O12
Molecular Weight	1269.65
Molecular Structure
Quality Standard	97% up by HPLC, USP
Appearance	White powder

COA of Leuprolide acetate

ITEMS	SPECIFICATION	RESULT
Appearance	White powder	Conforms
Solubility	Soluble in water or 1% acetic acid at a concentration of ≥1mg/ml to give a clear, colorless solution	Conforms
Identity	IR Same with the reference spectrum of Leuprolide	Conforms
	HPLC Same with the reference solution	Conforms
	Amino Acid Analysis	Conforms
	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	Present 0.99 1.05 2.02 1.02 0.98 1.01 present
Specific Optical Rotation	-38.0～-42.0° [a]20D(c=1，1% HAc)	-40.1°
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%	0.17% Conforms Conforms Conforms Conforms 0.17%
Acetate Content(By HPLC)	4.7~9.0%	7.5%
Water Content(Karl Fischer)	≤5.0%	1.5%
Sulphate ash	≤0.3%	Conforms
Bacterial Endotoxins	≤16.7 IU/mg	Conforms
Residual Organic Solvents	Acetonitrile ≤0.041%(By GC) DMF ≤0.088%(By GC) MEOH ≤0.3%(By GC) TFA ≤0.1%(By HPLC)	Conforms Conforms Conforms Conforms
Assay(By Anhydrous, Acetic Acid-free )	97.0～103.0%	99.5%

Usage

Function of Leuprolide Acetate

Leuprolide is a gonadotropin drug, a villous solid, and is often used clinically for endometriosis; uterine fibroids accompanied by menorrhagia, lower abdominal pain, low back pain and anemia; premenopausal breast cancer, and Estrogen receptor-positive patients; prostate cancer; central precocious puberty.

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