98% up by HPLC USP32 LETROZOLE 112809-51-5

Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:98% up by HPLC USP32 LETROZOLE 112809-51-5
CAS No.:112809-51-5
Standard:USP, BP, EP, JP, 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

  • Monthly Production Capacity: 1000kg

    Packaging Information: 25kg/drum 1kg/bottle

  • Delivery Lead Time: 7 days after payment

    Sample Provided: yes

    Payment Terms: L/L

     

    Product Information

     

    Product name

    Letrozole

    Molecular Formula

    C17H11N5

    Molecular Weight

    285.3

    CAS No.

    112809-51-5

    Quality Standard

    USP32, medical grade

    Appearance

    White powder

     

    COA of Letrozole

     

    Items

    Specification

    Appearance

    White to yellowish, crystalline powder

    Identification

    A.IR spectrum of sample should be identical to that of Reference Standard;

    The retention time of major peak in the chromatogram of the Assay preparation should correspond to that in the chromatogram of Standard preparation, as obtained in the Assay.

    Showing the white precipitate reaction.

    Water

    Not more than 0.3%

    Residue on Ignition

    Not more than 0.1%

    Heavy Metals

    Not more than 0.001%

     

    Related Compounds

    Compound A: Not more than 0.1%

    4,4’,4”-methylidenetrisbenzonitrile: Not more than 0.2%

    Any other impurity: Not more than 0.1%

    All other impurities: Not more than 0.3%

    Residual Sovents

    Ethanol: Not more than 3000ppm

    Ethyl acetate: Not more than 2000ppm

    DMF: Not more than 880ppm

    Microbe Limit

    Bacteria: Not more than 200/g

    Mold and yeast: Not more than 50/g

    Escherichia coli: should be absent

    Assay(anhydrous)

    98.0% to 102.0% of Cl7H11N5 on dried basis

    Packaging and Storage

    Preserve in tight containers at controlled room temperature.

    Conclusion

    Conforms to the USP32.

     

    Usage

     

    Function of Letrozole
    Letrozole is a new generation of highly selective aromatase inhibitors. It is a synthetic benztriazole derivative. By inhibiting aromatase, estrogen levels are reduced, thereby eliminating the stimulating effect of estrogen on tumor growth. The activity in the body is 150-250 times stronger than that of the first generation aromatase inhibitor amuromet. Because of its high selectivity, it does not affect glucocorticoids, mineralocorticoids, and thyroid function. Large doses have no inhibitory effect on the secretion of adrenal corticosteroids, so it has a high therapeutic index. Various preclinical studies have shown that letrozole has no potential toxicity, mutagenicity and carcinogenic effects on various systems and target organs in the whole body, and has less toxic and side effects, and is well tolerated. Compared with estrogen drugs, the anti-tumor effect is stronger. It is suitable for the treatment of postmenopausal patients with advanced breast cancer who are not responding to anti-estrogen therapy and early treatment of breast cancer.

     

    In December 2005, the British drug and health product regulatory agency approved Letrozole (Fron) produced by Novartis of Switzerland to be used in the treatment of breast cancer patients, allowing it to be used in surgically treated, early menopausal hormone-positive mammary glands Cancer patients. This is the second aromatase inhibitor approved following the approval of AstraZeneca ’s Rainin in June 2005. Both drugs have shown in clinical trials that they can better prevent the risk of breast cancer recurrence compared to current standard tamoxifen treatment.

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