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  • Itraconazole Ep Ip Bp Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name ITRACONAZOLE EP CAS No: 84625- 61- 6

    Batch No: ITR/ 011114 A. R. No 14/ FP/ ITR/ 0111

    Date of Manufacture Nov- 2014 Date of Analysis 02- 11- 14

    Batch Quantity 100 kg Date of Retest Jan- 2017

    Sr. No Test Results Acceptance Criteria

    1. Appearance Complies White to Off white crystalline powder

    2. Solubility Complies Practically insoluble in water, freely soluble in

    methylene chloride, sparingly soluble in

    tetrahydrofuran, very slightly soluble in

    alcohol.

    3. Identification 168.2°C to 169.3ºC

    Complies

    Complies A] Melting Point: 166ºC to 170ºC

    B] By I. R.

    C] By T. L. C

    D] By reaction ( a) of Chloride.

    4. Solution S Complies Dissolve 2gm in methylene chloride and

    dilute to 20ml of the same solvent.

    5. Appearance of solution Complies Solution S is clear and not more intensely

    colored than reference solution BY6.

    6. Optical rotation - 0.008º - 0.10º to +0.10º determined on solution S.

    7. Related substances

    [ By H. P. L. C. ]

    Single impurity

    Total impurity

    0.18%

    0.31%

    NMT 0.50%

    NMT 1.25%

    8. Loss On Drying 0.25% NMT 0.5%

    9. Sulphated Ash 0.07% NMT 0.1%

    10. Assay [ By Titration] 99.63% 98.5% to 101.5% [ on dried basis]

    Itraconazole

    Itraconazole2DACS. svg

    Systematic ( IUPAC) name

    ( 2R, 4S) - rel- 1- ( Butan- 2- yl) - 4- { 4- [ 4- ( 4- { [ ( 2R, 4S) - 2- ( 2, 4- dichlorophenyl) - 2- ( 1H- 1, 2, 4- triazol- 1- ylmethyl) - 1, 3- dioxolan- 4- yl] methoxy} phenyl) piperazin- 1- yl] phenyl} - 4, 5- dihydro- 1H- 1, 2, 4- triazol- 5- one

    Clinical data

    Trade names Sporanox

    AHFS/ Drugs. com monograph

    MedlinePlus a692049

    Pregnancy

    category

    AU: B3

    US: C ( Risk not ruled out)

    Legal status

    AU: Prescription Only ( S4)

    CA: ℞ - only

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration Oral and i. v. , Oral only ( UK and US)

    Pharmacokinetic data

    Bioavailability 55% , maximal if taken with full meal

    Protein binding 99.8%

    Metabolism hepatic ( CYP3A4)

    Biological half- life 21 hours

    Excretion Urine, faeces

    Identifiers

    CAS Registry Number 84625- 61- 6 Yes

    ATC code J02AC02

    PubChem CID: 55283

    DrugBank DB01167 Yes

    ChemSpider 49927 Yes

    UNII 304NUG5GF4 Yes

    KEGG D00350 Yes

    ChEBI CHEBI: 6076 Yes

    ChEMBL CHEMBL22587 Yes

    Chemical data

    Formula C35H38Cl2N8O4

    Molecular mass 705.64


    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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