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  • Dexamethasone Usp Ip Bp Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Dexamethasone USP CAS No: 50- 02- 2

    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 By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

    4. Related Substances

    Individual Impurity Total Impurity

    0.32 %

    1.32%

    NMT 1.0%

    NMT 2.0%

    5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) +74º Between + 72° to +80°

    6. Loss on drying 0.12% NMT 0.5%

    7. Residue On Ignition 0.09% NMT 0.2%

    8. Assay HPLC 98.43% 97.0% –102.0%

    . .

    Dexamethasone

    Skeletal formula of dexamethasone

    Ball- and- stick model of the dexamethasone molecule

    Systematic ( IUPAC) name

    ( 8S, 9R, 10S, 11S, 13S, 14S, 16R, 17R) - 9- Fluoro- 11, 17- dihydroxy- 17- ( 2- hydroxyacetyl) - 10, 13, 16- trimethyl- - dodecahydro- 3H- cyclopenta[ a] phenanthren- 3- one

    Clinical data

    AHFS/ Drugs. com monograph

    MedlinePlus a682792

    Pregnancy

    category

    AU: A

    US: C ( Risk not ruled out)

    Legal status

    AU: Prescription Only ( S4)

    CA: ℞ - only

    UK: Prescription- only ( POM)

    US: ℞ - only

    Routes of

    administration Oral, IV, IM, SC and IO

    Pharmacokinetic data

    Bioavailability 80- 90%

    Protein binding 77%

    Metabolism hepatic

    Biological half- life 190 minutes

    Excretion Urine ( 65% )

    Identifiers

    CAS Registry Number 50- 02- 2 Yes

    ATC code A01AC02 C05AA09, D07AB19, D10AA03, H02AB02, R01AD03, S01BA01, S02BA06, S03BA01

    PubChem CID: 5743

    IUPHAR/ BPS 2768

    DrugBank DB01234

    ChemSpider 5541 Yes

    UNII 7S5I7G3JQL Yes

    KEGG D00292 Yes

    ChEBI CHEBI: 41879 Yes

    ChEMBL CHEMBL384467 Yes

    Chemical data

    Formula C22H29FO5

    Molecular mass 392.461 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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