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  • Cinacalcet Hcl Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Cinacalcet HCl CAS No: 364782- 34- 3

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

    2. Identification Complies HPLC retention time

    3. Purity 99.7% NLT 99.5%

    4. Total impurity 0.10% NMT 0.5%

    5. Individual impurity 0.05% NMT 0.3%

    6. Heavy metals 8 PPM NMT 20 PPM

    7. Water content 0.2% NMT 1.0%

    8. Residue on ignition 0.03% NMT 0.1%

    9. Assay 99.3% 98.5% to 101.0%

    Cinacalcet

    Cinacalcet Structural Formulae. png

    Cinacalcet ball- and- stick. png

    Systematic ( IUPAC) name

    ( R) - N- [ 1- ( 1- naphthyl) ethyl] - 3-

    [ 3- ( trifluoromethyl) phenyl] propan- 1- amine

    Clinical data

    AHFS/ Drugs. com monograph

    MedlinePlus a605004

    Licence data EMA: Link, US FDA: link

    Pregnancy

    category

    AU: B3

    US: C ( Risk not ruled out)

    Legal status

    ℞ ( Prescription only)

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability 20 to 25%

    Increases if taken with food

    Protein binding 93 to 97%

    Metabolism Hepatic ( CYP3A4- , CYP2D6- and CYP1A2- mediated)

    Biological half- life 30 to 40 hours

    Excretion Renal ( 80% ) and fecal ( 15% )

    Identifiers

    CAS Registry Number 226256- 56- 0 Yes

    ATC code H05BX01

    PubChem CID: 156419

    IUPHAR/ BPS 3308

    DrugBank DB01012 Yes

    ChemSpider 137743 Yes

    UNII UAZ6V7728S Yes

    KEGG D03504 Yes

    ChEBI CHEBI: 48390 Yes

    ChEMBL CHEMBL1201284

    Chemical data

    Formula C22H22F3N

    Molecular mass 357.412 g/ mol


    Company Contact:


    • Phone: 912406641875

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

    • Email: Email


    Published date: September 6, 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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