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  • Duloxetine Hydrochloride Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Duloxetine hydrochloride CAS No: 136434- 34- 9

    Batch No: DUL/ 011114 A. R. No 14/ FP/ DUL/ 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 A white to almost white crystalline powder

    2. Identification Complies The IR absorption spectrum is accordant with

    the spectrum obtained with CRS

    3. Assay 100.31% 97.5% to 102.0%

    4. Solubility Complies Soluble in methanol, slightly soluble in water,

    almost insoluble in n- hexane

    5. Residue on ignition 0.07% NMT 0.1%

    6. Heavy metals Complies NMT 0.001%

    7. Loss on drying 0.02% NMT 0.5%

    8. Related substances

    Impurity F

    Unknown impurity

    Total impurities

    0.06%

    0.008%

    0.08%

    NMT 0.4%

    NMT 0.1%

    NMT 0.5%

    9. Chirality Not detected NMT 0.5%

    10. Residual solvents

    Ethanol

    Ethyl acetate

    Cycohexane

    Toulene

    0.02%

    Not detected

    Not detected

    NMT 0.194%

    NMT 0.089%

    Duloxetine

    Duloxetine. svg

    Duloxetine- 3D- ball- model. png

    Systematic ( IUPAC) name

    ( +) - ( S) - N- Methyl- 3- ( naphthalen- 1- yloxy) - 3- ( thiophen- 2- yl) propan- 1- amine

    Clinical data

    Trade names Cymbalta

    AHFS/ Drugs. com monograph

    MedlinePlus a604030

    Licence data EMA: Link, US FDA: link

    Pregnancy

    category

    AU: B3

    US: C ( Risk not ruled out)

    Legal status

    AU: Prescription Only ( S4)

    CA: ℞ - only

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration Oral

    Pharmacokinetic data

    Bioavailability ~ 50% ( 32% to 80% )

    Protein binding ~ 95%

    Metabolism Liver, two P450 isozymes, CYP2D6 and CYP1A2

    Biological half- life 12.1 hours

    Excretion 70% in urine, 20% in feces

    Identifiers

    CAS Registry Number 116539- 59- 4 ( free base)

    136434- 34- 9 ( hydrochloride)

    ATC code N06AX21

    PubChem CID: 60835

    IUPHAR/ BPS 202

    DrugBank DB00476 Yes

    ChemSpider 54822 Yes

    UNII O5TNM5N07U Yes

    KEGG D07880 Yes

    ChEBI CHEBI: 36795 Yes

    ChEMBL CHEMBL1175 Yes

    PDB ligand ID 29E ( PDBe, RCSB PDB)

    Chemical data

    Formula C18H19NOS

    Molecular mass 297.41456 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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