97% up by HPLC USP Leuprolide Acetate 74381-53-6

Category:Bio Products > Protein/Antigen/Polypeptide > Other Protein
Product Name:97% up by HPLC USP Leuprolide Acetate 74381-53-6
CAS No.:74381-53-6
Standard:In-house Standards
Price(USD):Negotiable
Company:Sinoway Industrial Co.Ltd.

Basic Info
  • Grade: Pharmaceutical Grade

    Factory Location: Xiamen Fujian

    Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa

  • Monthly Production Capacity: 10ton/year

    Packaging Information: 25kg/drum; 5kg/bag, 1kg/bag

  • Delivery Lead Time: 7 days after payment

    Sample Provided: yes

    Payment Terms: L/L

     

    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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