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  • Doxorubicin Hcl Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Doxorubicin HCl CAS No:

    Batch No: DOX/ 011114 A. R. No 14/ FP/ DOX/ 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 Orange- red or red crystalline powder. No

    visible evidence of contamination by foreign

    matter

    2. Solubility Complies Soluble in water and methanol; slightly

    soluble in ethanol; practically insoluble in

    acetone

    3. Identification A Complies IR spectrum corresponds to the IR spectrum

    of the reference standard

    4. Identification B Complies The principle peak in the chromatogram

    obtained with the test solution under Assay is

    similar in retention time to the principle peak

    in the chromatogram obtained with the

    reference solution

    5. PH 5.1 4.0 to 5.5

    6. Water 2.2% NMT 4.0%

    7. Residual solvents

    Acetone

    Acetone+Ethanol

    Dichloromethane

    Methanol

    0.31%

    1.4%

    Not Detected

    Not Detected

    NMT 0.5%

    NMT 2.5%

    NMT 0.06%

    NMT 0.3%

    8. Related substances

    Impurity A( Doxorubicinone)

    Any other unknown impurity

    Total unknown impurities

    Total impurities

    0.07%

    0.09%

    0.3%

    0.4%

    NMT 0.2%

    NMT 1.0%

    9. Assay 98.6% 98.0% to 102.0%

    .

    Doxorubicin

    Doxorubicin2DCSD. svg

    Doxorubicin 3D ball. png

    Systematic ( IUPAC) name

    ( 7S, 9S) - 7- [ ( 2R, 4S, 5S, 6S) - 4- amino- 5- hydroxy- 6- methyloxan- 2- yl] oxy- 6, 9, 11- trihydroxy- 9- ( 2- hydroxyacetyl) - 4- methoxy- 8, 10- dihydro- 7H- tetracene- 5, 12- dione

    Clinical data

    Trade names Adriamycin

    AHFS/ Drugs. com monograph

    MedlinePlus a682221

    Pregnancy

    category

    AU: D

    US: D ( Evidence of risk)

    Legal status

    AU: Prescription Only ( S4)

    CA: ℞ - only

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration Intravenous, intravesical

    Pharmacokinetic data

    Bioavailability 5% ( Oral)

    Protein binding 75% [ 1]

    Metabolism Hepatic

    Biological half- life Triphasic; 12 minutes, 3.3 hours, 30 hours. Mean: 1- 3 hours[ 1] [ 2]

    Excretion Urine ( 5- 12% ) , faeces ( 40- 50% ) [ 1]

    Identifiers

    CAS Registry Number 23214- 92- 8 Yes

    ATC code L01DB01

    PubChem CID: 31703

    IUPHAR/ BPS 7069

    DrugBank DB00997 Yes

    ChemSpider 29400 Yes

    UNII 80168379AG Yes

    KEGG D03899 Yes

    ChEBI CHEBI: 28748 Yes

    ChEMBL CHEMBL53463

    Chemical data

    Formula C27H29NO11

    Molecular mass 543.52 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 7, 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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