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  • Letrozole Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Letrozole USP CAS No: 112809- 51- 5

    Batch No: LET/ 030313 A. R. No 13/ FP/ LET/ 0303

    Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

    Batch Quantity 165 kg Date of Retest Jan- 2016

    Sr. No Test Results Acceptance Criteria

    1. Appearance

    2. Solubility

    3. Identification

    Complies a) By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

    Complies b) By HPLC: Retention time of the principle peak in the chromatogram obtained with sample solution should match with that of the principle peak in chromatogram obtained with standard solution.

    4. Related Substances

    Individual Impurity Total Impurity

    0.03%

    0.18%

    NMT 0.1%

    NMT 0.3%

    5. Heavy Metals Complies 10ppm

    6. Water Content by KF 4.7% NMT 0.3%

    7. Residue On Ignition 0.065% NMT 0.1%

    8. Assay HPLC 99.54% 98.0% –102.0%

    Letrozole

    Letrozole2DACS. svg

    Letrozol3D. png

    Systematic ( IUPAC) name

    4, 4' - ( ( 1H- 1, 2, 4- triazol- 1- yl) methylene) dibenzonitrile

    Clinical data

    Trade names Femara

    AHFS/ Drugs. com monograph

    MedlinePlus a698004

    Licence data US FDA: link

    Pregnancy

    category

    US: D ( Evidence of risk)

    Legal status

    CA: Schedule VII

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability 99.9%

    Protein binding 60% , mainly to albumin

    Metabolism pharmacologically- inactive carbinol metabolite ( 4, 4΄ - methanol- bisbenzonitrile) [ 1]

    Biological half- life 2 days[ 1]

    Excretion Kidneys[ 1]

    Identifiers

    CAS Registry Number 112809- 51- 5 Yes

    ATC code L02BG04

    PubChem CID: 3902

    IUPHAR/ BPS 5209

    DrugBank DB01006 Yes

    ChemSpider 3765 Yes

    UNII 7LKK855W8I Yes

    KEGG D00964 Yes

    ChEBI CHEBI: 6413 Yes

    ChEMBL CHEMBL1444 Yes

    Chemical data

    Formula C17H11N5

    Molecular mass 285.303 g/ mol


    Company Contact:


    • Phone: 912406641875

    • Address: PLOT NO: 04 JALGAON ROAD, HARSOOL, AURANGABAD, India

    • Email: Email


    Published date: September 9, 2015 -

    • Business Description: We, at SWAPNROOP, are committed to providing affordable Drugs &

      Pharmaceuticals of global quality standards to Pharma Companies all over

      the world. In our warehouse facilities, approved by FDA. we supply

      Pharmaceutical Finished products, Dental products and Active

      Pharmaceutical Ingredients.

      We, at SWAPNROOP, are committed to providing affordable Drugs & Pharmaceuticals of global quality standards to Pharma Companies all over the world. Our warehouse facilities is approved by FDA and we are specializes in sales and marketing of Pharmaceutical Finished products, Pharmaceutical Active Ingredients (API's) and Dental products, providing a wide range of quality and affordable products to a large number of pharmaceutical companies, reputed private and government/semi government organizations/ research centers as well as universities.

      We supply and market over 500 molecules and their combinations in multiple dosage forms, catering to patient needs in various therapies. These include Anti infectives, Cardiovascular, Pain management, Central Nervous System (CNS), Gastrointestinal, Respiratory, Dermatology, Orthopaedics, Nutritionals, Urology and Dental.

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