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  • Bromfenac Sodium Usp Ip Ep Manufacturer - India

    price: contact company for price

    CERTIFICATE OF ANALYSIS

    Product Name Bromfenac Sodium CAS No:

    Batch No: BRO/ 011114 A. R. No 14/ FP/ BRO/ 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 Yellowish- orange to orange crystalline powder. No

    Visible evidence of contamination for foreign matter. Odorless.

    2. Solubility Complies Freely soluble in water, sparingly soluble in methanol,

    practically insoluble in ethyl acetate.

    3. Identification Complies

    Complies

    Complies 1. Max. absorption exhibited at 268nm to 379nm

    2. The infrared absorption spectrum corresponds to that

    of reference standard

    3. The identification of sodium salt is positive reaction

    4. PH 8.9 8.3 to 9.5

    5. Chlorides 0.05% NMT 0.05%

    6. Loss on drying 7.16% 6.50% to 7.50%

    7. Heavy metals ( USP) 10 PPM NMT 10 PPM

    8. Heavy metals ( EP) 10 PPM NMT 10 PPM

    9. Related substances Impurity A≤ 0.10% , LOD=0.0014% , LOQ=0.0043%

    Impurity B≤ 0.10% , LOD=0.00092% , LOQ=0.0028%

    Impurity C≤ 0.10% , LOD=0.0022% , LOQ=0.0065%

    Impurity D≤ 0.10% , LOD=0.00097% , LOQ=0.0030%

    Max other single impurity≤ 0.10%

    Total impurities≤ 0.50% 0.18% NMT 0.0014%

    NMT 0.068%

    NMT 0.0022%

    NMT 0.00097%

    NMT 0.055%

    NMT 0.18%

    10. Residual solvents Methyl benzene≤ 890ppm

    <Dichloromethane≤ 600ppm

    Diisopropyl ether≤ 500ppm

    Ethanol≤ 3000ppm

    Methanol ≤ 3000ppm

    2- methoxyethanol≤ 50ppm

    Acetone≤ 3000ppm

    Benzene ≤ 2ppm NMT 14.6 PPM

    NMT 23 PPM

    NMT 19.8 PPM

    NMT 21.9 PPM

    NMT 8 PPM

    NMT 1 PPM

    NMT 142 PPM

    NMT 0.15 PPM

    . .

    Bromfenac

    Bromfenac. svg

    Systematic ( IUPAC) name

    2- [ 2- amino- 3- ( 4- bromobenzoyl) phenyl] acetic acid

    Clinical data

    Trade names Bromday, Prolensa

    AHFS/ Drugs. com monograph

    MedlinePlus a611018

    Pregnancy

    category

    C

    Legal status

    US: ℞ - only

    Routes of

    administration Oral ( discontinued)

    ophthalmic

    Identifiers

    CAS Registry Number 91714- 94- 2 Yes

    ATC code S01BC11

    PubChem CID: 60726

    IUPHAR/ BPS 7131

    DrugBank DB00963 Yes

    ChemSpider 54730 Yes

    UNII 864P0921DW Yes

    KEGG D07541 Yes

    ChEBI CHEBI: 240107 Yes

    ChEMBL CHEMBL1077 Yes

    Chemical data

    Formula C15H12BrNO3

    Molecular mass 334.16g/ 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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