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  • Buprenorphine Hydrochloride Usp Ip Ep Bp Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Buprenorphine Hydrochloride USP CAS No:

    Batch No: BUP/ 030313 A. R. No 13/ FP/ BUP/ 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 a) By IR Spectrum: The infrared absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard.

    Complies b) By chloride test: The sample solution meets the requirements.

    4. Related Substances

    Individual Impurity Total Impurity

    0.11 %

    0.29%

    NMT 0.25%

    NMT 0.65%

    5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) - 94º Between - 92° to - 98°

    6. pH in a solution containing 10 mg/ mL 5.3 Between 4.0- 6.0

    7. Water Content by KF 0.6% NMT 1.0%

    11. Residue On Ignition 0.03% NMT 0.1%

    12. Assay HPLC 99.37% 98.5 to 101.0%

    . .

    Buprenorphine

    Skeletal formula of buprenorphine

    Ball- and- stick model of the buprenorphine molecule

    Systematic ( IUPAC) name

    ( 2S) - 2- [ ( 5R, 6R, 7R, 14S) - 9α - cyclopropylmethyl- 4, 5- epoxy- 6, 14- ethano- 3- hydroxy- 6- methoxymorphinan- 7- yl] - 3, 3- dimethylbutan- 2- ol

    Clinical data

    Trade names Buprenex, Subutex, Suboxone, Butrans, Cizdol

    AHFS/ Drugs. com monograph

    MedlinePlus a605002

    Pregnancy

    category

    AU: C

    US: C ( Risk not ruled out)

    Legal status

    AU: Controlled ( S8)

    CA: Schedule I

    UK: Class C

    US: Schedule III

    Routes of

    administration sublingual, IM, IV, transdermal, intranasal, rectally, orally.

    Pharmacokinetic data

    Bioavailability 30% ( sublingual) [ 1] / 48.2±8.35% ( intranasal) [ 2]

    Protein binding 96%

    Metabolism hepatic

    CYP3A4, CYP2C8

    Biological half- life 20–70, mean 37 hours

    Excretion biliary and renal

    Identifiers

    CAS Registry Number 52485- 79- 7 Yes

    ATC code N02AE01 N07BC01

    PubChem CID: 644073

    IUPHAR/ BPS 1670

    DrugBank DB00921 Yes

    ChemSpider 559124 Yes

    UNII 40D3SCR4GZ Yes

    KEGG D07132 Yes

    ChEBI CHEBI: 3216 Yes

    ChEMBL CHEMBL1201894

    Chemical data

    Formula C29H41NO4

    Molecular mass 467.64 g/ mol


    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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