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  • Rifabutin Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Rifabutin USP CAS No: 72559- 06- 9

    Batch No: RIF/ 030313 A. R. No 13/ FP/ RIF/ 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

    0.18%

    1.4%

    NMT 0.5%

    NMT 3.0%

    5. Water Content by KF 1.2% NMT 2.5%

    6. Assay HPLC 978 mg/ mg 950–1020 mg/ mg

    Rifabutin structure. svg

    Systematic ( IUPAC) name

    ( 9S, 12E, 14S, 15R, 16S, 17R, 18R, 19R, 20S,

    21S, 22E, 24Z) - 6, 16, 18, 20- tetrahydroxy- 1' -

    isobutyl- 14- methoxy- 7, 9, 15, 17, 19, 21, 25-

    hepta- methyl- spiro[ 9, 4- ( epoxypentadeca

    [ 1, 11, 13] trienimino) - 2H- furo- [ 2' , 3' : 7, 8] - naphth

    [ 1, 2- d] imidazol- 2, 4' - piperidin] - 5, 10, 26- ( 3H, 9H) -

    trione- 16- acetate

    Clinical data

    Trade names Mycobutin

    AHFS/ Drugs. com monograph

    MedlinePlus a693009

    Pregnancy

    category

    C ( Australia) , B ( United States)

    Legal status

    POM ( UK) , ℞ - only ( U. S. )

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability 85%

    Protein binding 85%

    Metabolism Hepatic

    Biological half- life 28 to 62 hours ( mean)

    Excretion Renal and fecal

    Identifiers

    CAS Registry Number 72559- 06- 9 Yes

    ATC code J04AB04

    PubChem CID: 6323490

    DrugBank DB00615 Yes

    ChemSpider 10482168 Yes

    UNII 1W306TDA6S Yes

    KEGG D00424 Yes

    ChEBI CHEBI: 45367 Yes

    ChEMBL CHEMBL444633 Yes

    Chemical data

    Formula C46H62N4O11

    Molecular mass 847.005 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 14, 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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