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  • Nitrofurantoin Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Nitrofurantoin USP CAS No: 67- 20- 9

    Batch No: NIT/ 030313 A. R. No 13/ FP/ NIT/ 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 Very slightly soluble in water and in alcohol; soluble in dimethyl formamide. Very slightly soluble in water and in alcohol; soluble in dimethylformamide.

    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. Water Content by KF 7.1% 6.5% –7.5%

    5. Assay HPLC 99.45% 98.0% –102.0%

    6. Specific Surface Area 0.12 m2/ g 0.045–0.20 m2/ g

    Nitrofurantoin

    Structural formula of nitrofurantoin

    Ball- and- stick model of the nitrofurantoin molecule

    Systematic ( IUPAC) name

    ( E) - 1- [ ( 5- nitro- 2- furyl) methylideneamino] imidazolidine- 2, 4- dione

    Clinical data

    Trade names Macrobid, Macrodantin and others

    AHFS/ Drugs. com monograph

    MedlinePlus a682291

    Pregnancy

    category

    AU: A

    US: B ( No risk in non- human studies)

    Legal status

    AU: Prescription Only ( S4)

    CA: ℞ - only

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration by mouth

    Pharmacokinetic data

    Bioavailability 40%

    Metabolism liver ( 75% )

    Biological half- life 20 minutes

    Excretion urine and bile

    Identifiers

    CAS Registry Number 67- 20- 9 Yes

    ATC code J01XE01

    PubChem CID: 6604200

    DrugBank DB00698 Yes

    ChemSpider 5036498 Yes

    UNII 927AH8112L Yes

    KEGG D00439 Yes

    ChEBI CHEBI: 71415

    ChEMBL CHEMBL572 Yes

    Chemical data

    Formula C8H6N4O5

    Molecular mass 238.16

    SMILES[ show]

    InChI[ show]

    Physical data

    Melting point 270 to 272 °C ( 518 to 522 °F) ( decomp. )


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 10, 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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