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  • Rosuvastatin Calcium Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Rosuvastatin Calcium CAS No:

    Batch No: ROS/ 011114 A. R. No 14/ FP/ ROS/ 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 yellow powder

    2. Identification Complies

    Complies A. IR- Spectrum

    B. UV

    3. Calcium content 3.8% 3.5% to 4.5%

    4. Water 4.3% NMT 5.0%

    5. Specific rotation 18.2

    14.0 to 20.0

    6. Heavy metals 0.002% NMT 0.002%

    7. Related substance ( HPLC)

    Diastereomer

    Rosuvastatin Lactone

    Diene

    Unknown single impurity

    Total impurity

    Complies

    0.7%

    NMT 0.3%

    NMT 0.2%

    NMT 1.0%

    8. Assay on dry basis 99.2% 98.0% to 102.0%

    . .

    Rosuvastatin

    Rosuvastatin2DCSD. svg

    Rosuvastatin3Dan. gif

    Systematic ( IUPAC) name

    ( 3R, 5S, 6E) - 7- [ 4- ( 4- fluorophenyl) - 2- ( N- methylmethanesulfonamido) - 6- ( propan- 2- yl) pyrimidin- 5- yl] - 3, 5- dihydroxyhept- 6- enoic acid

    Clinical data

    Trade names Crestor

    AHFS/ Drugs. com monograph

    MedlinePlus a603033

    Pregnancy

    category

    AU: D

    US: X ( Contraindicated)

    Legal status

    AU: Prescription Only ( S4)

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration oral

    Pharmacokinetic data

    Bioavailability 20% [ 1]

    Protein binding 88% [ 1]

    Metabolism Liver ( CYP2C9 and CYP2C19- mediated; only minimally ( ~10% ) metabolised) [ 1]

    Biological half- life 19 hours[ 1]

    Excretion Faeces[ 1]

    Identifiers

    CAS Registry Number 287714- 41- 4 Yes

    ATC code C10AA07

    PubChem CID: 446157

    IUPHAR/ BPS 2954

    DrugBank DB01098 Yes

    ChemSpider 393589

    UNII 413KH5ZJ73 Yes

    KEGG D01915

    ChEBI CHEBI: 38545

    ChEMBL CHEMBL1496

    PDB ligand ID FBI ( PDBe, RCSB PDB)

    Chemical data

    Formula C22H28FN3O6S

    Molecular mass 481.539


    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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