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  • Dextroamphetamine Sulfate Usp Ip Ep Bp Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Dextroamphetamine Sulfate USP CAS No: 51- 63- 8

    Batch No: DEX/ 030313 A. R. No 13/ FP/ DEX/ 0303

    Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

    Batch Quantity 165 kg Date of Retest Jan- 2016

    Sr. No Test Results Acceptance Criteria

    1. Appearance

    2. Solubility

    3. Identification

    Complies Sulfate: Meets the requirements

    4. Related Substances

    Individual Impurity Total Impurity

    0.05%

    0.13%

    NMT 0.1%

    NMT 0.5%

    5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) +21.1º Between +20° to +23.5°

    6. pH 5.1 Between 5.0–6.0

    7. Loss on drying 0.4% NMT 1.0%

    8. Residue On Ignition 0.06% NMT 0.1%

    . .

    Dextroamphetamine

    D- amphetamine. svg

    Systematic ( IUPAC) name

    ( 2S) - 1- phenylpropan- 2- amine

    Clinical data

    Trade names Dexedrine, Dextrostat, Metamina

    AHFS/ Drugs. com monograph

    MedlinePlus a605027

    Licence data US Daily Med: link

    Pregnancy

    category

    AU: B3

    US: C ( Risk not ruled out)

    Legal status

    AU: Controlled ( S8)

    CA: Schedule I

    UK: Class B

    US: Schedule II

    ℞ ( Prescription only)

    Dependence

    liability Physical: None

    Psychological: Moderate

    Addiction

    liability Moderate

    Routes of

    administration oral, nasal inhalation

    Pharmacokinetic data

    Bioavailability Oral 75–100% [ 1]

    Metabolism CYP2D6, [ 2] DBH, [ 3] FMO3, [ 4] XM- ligase, [ 5] and ACGNAT[ 6]

    Onset of action IR dosing: Immediate

    XR dosing: 1.5–2 hours[ 7] [ 8]

    Biological half- life 9–11 hours[ 2] [ 9]

    pH- dependent: 8–31 hours[ 10]

    Duration of action IR dosing: 3–7 hours[ 7] [ 11]

    XR dosing: 12 hours[ 7] [ 8] [ 11]

    Excretion Renal ( 45% ) ; [ 12] urinary pH- dependent

    Identifiers

    CAS Registry Number 51- 64- 9 Yes

    ATC code N06BA02

    PubChem CID: 5826

    IUPHAR/ BPS 2147

    DrugBank DB01576 Yes

    ChemSpider 5621 Yes

    UNII TZ47U051FI Yes

    KEGG D03740 Yes

    ChEBI CHEBI: 4469 Yes

    ChEMBL CHEMBL612 Yes

    Chemical data

    Formula C9H13N

    Molecular mass 135.20622

    SMILES[ show]

    InChI[ show]

    Physical data

    Density 0.913 g/ cm3

    Boiling point 201.5 °C ( 394.7 °F)

    Solubility in water 20 mg/ mL ( 20 °C)


    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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