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  • Calcium Pitavastatin Usp Ip Ep Bp Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Calcium pitavastatin CAS No:

    Batch No: CAL/ 011114 A. R. No 14/ FP/ CAL/ 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 powder or crystalline powder

    2. Specific optical rotation +21.9º +18.5º to +23.5º

    3. Identification Complies

    UV

    4. Water 2.1% NMT 5.0%

    5. Ca 4.53% 4.3% to 4.8%

    6. Enantiomric purity 0.10% NMT 1.0%

    7. Diastereomeric purity 0.28% NMT 1.0%

    8. Related substances 0.46% NMT 1.0%

    9. Heavy metals Complies NMT 20 PPM

    10. Chloride Complies NMT 0.1%

    11. Content 99.5% 99.0% to 101.0%

    12. Residual absorption Complies Complies

    .

    Pitavastatin

    Pitavastatin2DCSD. svg

    Pitavastatin3Dan. gif

    Systematic ( IUPAC) name

    ( 3R, 5S, 6E) - 7- [ 2- cyclopropyl- 4- ( 4- fluorophenyl) quinolin- 3- yl] - 3, 5- dihydroxyhept- 6- enoic acid

    Clinical data

    Trade names Livalo

    AHFS/ Drugs. com monograph

    MedlinePlus a610018

    Licence data US FDA: link

    Pregnancy

    category

    AU: D

    US: X ( Contraindicated)

    Legal status

    AU: Prescription Only ( S4)

    CA: ℞ - only

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability 60%

    Protein binding 96%

    Metabolism minimally CYP2C9

    Biological half- life 11 hours

    Excretion Faeces

    Identifiers

    CAS Registry Number 147511- 69- 1

    ATC code C10AA08

    PubChem CID: 5282452

    IUPHAR/ BPS 3035

    ChemSpider 4445604 Yes

    UNII M5681Q5F9P Yes

    ChEBI CHEBI: 32020

    ChEMBL CHEMBL1201753

    Chemical data

    Formula C25H24FNO4

    Molecular mass 421.461


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 5, 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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