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  • Cytarabine Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name CYTARABINE CAS No: 147- 94- 4

    Batch No: CYT/ 011114 A. R. No 14/ FP/ CYT/ 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 or almost white crystalline powder

    2. Solubility Complies Freely soluble in water, very slightly soluble in alcohol and in methylene chloride

    3. Identification Complies

    Complies IR

    HPLC

    4. Loss on drying 0.01% NMT 1.0%

    5. Specific optical rotation +157º +154º to +160º

    6. Heavy metals Complies NMT 10 PPM

    7. Sulphated ash 0.09% NMT 0.5%

    8. Chromatographic purity

    Total impurities

    Uracil arabinoside

    Maximum individual

    Impurity

    0.14%

    0.07%

    0.05%

    NMT 0.30%

    NMT 0.10%

    9. Residual solvents

    Ethanol

    Methanol

    Acetonitrile

    144 PPM

    Not detected

    Not detected

    NMT 5000 PPM

    NMT 3000 PPM

    NMT 410 PPM

    10. Volatile Organic Impurities Complies OVI classes 1, 2, 3

    11. Endotoxins

    12. Assay 100.1% 98% to 102%

    Cytarabine

    Cytarabin. svg

    Cytarabine ball- and- stick. png

    Systematic ( IUPAC) name

    4- amino- 1- [ ( 2R, 3S, 4R, 5R) - 3, 4- dihydroxy- 5- ( hydroxymethyl) oxolan- 2- yl] pyrimidin- 2- one

    Clinical data

    Trade names Cytosar- U

    AHFS/ Drugs. com monograph

    MedlinePlus a682222

    Pregnancy

    category

    AU: D

    US: D ( Evidence of risk)

    Legal status

    ℞ ( Prescription only)

    Routes of

    administration Injectable ( intravenous injection or infusion, intrathecal, or subcutaneously)

    Pharmacokinetic data

    Bioavailability 20% oral

    Protein binding 13%

    Metabolism Liver

    Biological half- life biphasic: 10 min, 1- 3 hr

    Excretion Renal

    Identifiers

    CAS Registry Number 147- 94- 4 Yes

    ATC code L01BC01

    PubChem CID: 6253

    IUPHAR/ BPS 4827

    DrugBank DB00987 Yes

    ChemSpider 6017 Yes

    UNII 04079A1RDZ Yes

    KEGG D00168 Yes

    ChEBI CHEBI: 28680 Yes

    ChEMBL CHEMBL803 Yes

    Chemical data

    Formula C9H13N3O5

    Molecular mass 243.217 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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